Topic: General

NorthX Biologics is a pioneering Swedish contract development and manufacturing organization (CDMO) that combines deep-rooted scientific heritage with cutting-edge biotechnological advancements. Headquartered in Matfors with an additional facility in Stockholm, NorthX specializes in a wide range of biologics modalities, including proteins, nucleic acids, and viral vectors. The company’s Innovation Hub plays a central role in supporting the development of both traditional and advanced therapies, a vital testing ground for new programs and approaches. With a commitment to sustainability and community involvement, NorthX leverages proprietary technologies and development and manufacturing experience to provide services that go beyond the typical CDMO, pioneering novel approaches for both large and small clients. In this Q&A, Chief Executive Officer Janet Hoogstraate, Ph.D., discusses the strategic initiatives helping the company to comprehensively address the evolving needs of the biopharmaceutical sector, in conversation with Pharma’s Almanac Editor in Chief David Alvaro, Ph.D.

David Alvaro (DA): To begin, can you share the story of the origins of NorthX Biologics and the foundational vision driving the company?

Janet Hoogstraate (JH): NorthX Biologics was officially established in October 2021, although the facilities and its people have long been operational under different entities and leadership dating back to 1963. Our founding vision was to create a state-of-the-art facility here in Matfors, Sweden, with advanced capabilities for biologics, including proteins, RNA, and cell therapies, primarily aimed at empowering R&D projects and innovative therapies where manufacturing might not yet be established. This focus is crucial, especially for smaller biotechs and even larger companies where not every project can be accommodated.

We have been able to leverage the legacy experience and expertise of sites and teams from our predecessor companies, like Cobra Biologics, to deliver on this new vision. The acquisition of the Stockholm-based Clinical Trial Manufacturing unit from Valneva last year not only expanded the geographical footprint but also enhanced our technical expertise and capabilities, particularly in mammalian expression systems and viral vectors. This combination of heritage, innovation, and modern capabilities continues to shape NorthX’s unique culture and strength.

DA: What are the values that define NorthX Biologics and the company’s culture?

JH: At NorthX, we say, “We are small enough to care; big enough to deliver.” Although this is a borrowed phrase, it captures our core very well. True values must be demonstrated consistently by an organization, not merely stated. For us, caring is central, and that care manifests in our focus on customer relationships and partnerships, which are built to last and are foundational to our operations.

Innovation is also an important pillar. Our Innovation Hub was truly central to the inception of NorthX, and that dedication to innovation cascades from there across all of our operations. 

Our long-standing site in Matfors is not just a workplace; it’s a community deeply rooted in the traditions of rural Sweden. This setting has shaped a strong culture of collaboration, where team dynamics and a collective ability to overcome challenges are key to our success. Our employees embody a tight-knit spirit that enhances our processes and drives continuous growth and development.

This emphasis on teamwork and community is integral not only locally but across all our interactions, playing a crucial role in successfully delivering projects. As we expand in Sweden and beyond, we continue to diversify our team. Successfully integrating a range of cultural backgrounds has enriched our company culture and bolstered our global operations. Our leadership team, with its diverse experiences from various industries, significantly contributes to our strategic and operational approaches, strengthening our internal capabilities and enhancing our position in the global market.

Reliability and experience underpin our ability to deliver on promises, ensuring that our partners can depend on us for both small-scale and large-scale projects.

DA: Are there any additional values or priorities you have personally brought to the company since your appointment as CEO last summer?

JH: I firmly believe in fostering a culture of accountability within the team. It’s crucial for me that team members feel empowered to make decisions independently while knowing they have my full support. This approach encourages a proactive rather than reactive decision-making process throughout the organization. I also strive to instill enthusiasm and engagement among our team members. Being genuinely engaged in what we do and helping each other succeed are fundamental principles I champion, and they drive the collective success and fulfillment of our roles.

DA: How are your core capabilities and services structured, and to what extent do you see them evolving in the near future?

JH: We describe our service as providing complete solutions. Whether it’s a large pharmaceutical company or a biotech startup with a groundbreaking idea needing clinical development, they may lack the necessary manufacturing expertise or capacity. That’s where we come in, offering a full CMC package that includes process and analytical development, manufacturing, quality control, quality assurance, and qualified person services.

We approach our services by dividing them into two main areas –– microbial and mammalian work –– each requiring specific expertise with some overlap. From there, we branch into various modalities like plasmids, mRNA, proteins, viral vectors, and cell therapies, but they all begin with the specific capabilities and expertise needed at the microbial and mammalian levels.

Looking forward, we are keenly observing the industry’s evolution. Our Chief Technology Officer Ola Tuvesson and his team stay actively engaged through collaborations, literature, and conferences to gauge emerging trends. Our goal is to evolve alongside our customers, ensuring that we are equipped with the right technologies to support their needs and ambitions, often before they even articulate them. This proactive approach allows us to adapt and potentially prioritize new modalities that align with market developments and client demands.

DA: What can you share about recent and forthcoming acquisitions and your overall growth strategy looking forward?

JH: Last year’s acquisition primarily aimed to enhance our mammalian capabilities, which were more developed at our Stockholm site compared with our headquarters in Matfors. This has significantly broadened our technical scope. Internally, we recognize that our technical capacity can be expanded by adding both personnel and new projects, so there is considerable potential for organic growth within our existing operations.

However, we are always looking for strategic acquisitions or partnerships that can extend our service offerings. When a new technology emerges that aligns with our customers’ needs, we evaluate whether to develop this capability in-house or through a company that brings the desired expertise and cultural fit. This proactive approach to potential acquisitions is a continuous focus for us.

Regionally, while we are rooted in Sweden and have traditionally served Nordic countries, we are actively expanding our presence in Europe and are increasingly looking toward the U.S. market. We have already established some key partnerships there and are committed to establishing a stronger customer base in the United States.

DA: Can you elaborate on the role of the Innovation Hub and its central role at NorthX?

JH: The Innovation Hub at NorthX is central to both our identity and strategy, not merely enabling early projects but providing state-of-the-art infrastructure for both non-GMP and GMP manufacturing. This includes cutting-edge techniques like mRNA manufacturing, allowing us to support innovative academic or biotech projects without the need for heavy investment in expertise or facilities. For example, we established an mRNA line in anticipation of its growing importance in modern therapies well before we had a specific project lined up.

The hub’s flexibility and responsiveness allow us to tailor our capabilities to customer needs swiftly, avoiding the typical delays of setting up complex equipment like reactors. It’s designed to quickly advance ideas from concept to next-phase development, offering researchers and startups the opportunity to work directly with our labs to move their projects forward and identify bottlenecks early on.

Moreover, our Innovation Hub serves as a testing ground for new technologies that may later integrate into our broader CDMO services. This includes proprietary technologies, such as our plasmids and our work with outer membrane vesicles.

This dual role of the Innovation Hub — supporting external innovation while enhancing our internal capabilities — ensures that we stay at the forefront of biotechnology, continuously integrating successful innovations into our manufacturing practices. It’s supported by Vinnova, Sweden’s innovation agency, which helps us stay connected to national and European research and funding networks, further enhancing our capacity to innovate. Through these efforts, we aim to offer complete solutions to clients of all sizes, helping them bring innovative therapies to patients. This is what drives us every day at NorthX.

DA: Are you working toward a specialized focus in one or more of your capabilities or aiming to remain remaining flexible to change in order to meet various customer needs and market demands?

JH: At NorthX, we operate within the advanced biologics sector, focusing primarily on GMP standards, although we also engage in non-GMP processes as steps toward concept testing and clinical manufacturing. Our capabilities encompass preclinical, clinical, and commercial manufacturing, enabling NorthX to support our clients throughout the entire development process. We clearly emphasize versatility and adaptability in our offerings. For instance, if a particular modality doesn’t see expected demand or market interest within a couple of years, we’re prepared to shift our focus. Our approach is to balance market demands with anticipated trends, ensuring that we can swiftly adapt and align our capabilities with emerging needs and opportunities in the biotech field.

DA: Could you discuss any current strategic alliances or partnerships that are crucial to NorthX’s success?

JH: Certainly, our strategic alliances are integral to our growth and innovation. Our engagement with immuno-oncology company Mendus illustrates our commitment to advancing cell therapy solutions for acute myeloid leukemia, reflecting our ability to tackle complex biologics manufacturing. Our work on outer membrane vesicles with vaccine development company Abera Biosciences not only advances novel biotechnological approaches but also supports our strategic focus on non-viral delivery systems as a promising alternative to conventional viral methods.

 Another strategic collaboration has been the recently completed OPENCORONA project (OPENCORONA | Karolinska Institutet), developing a DNA vaccine all the way to testing in humans, which was led by the Karolinska Institute, located near our Stockholm site. This project not only enhanced our connection with top European researchers from countries like Germany and Italy but also strengthened our network within a broad European alliance.

Additionally, we are part of AdBIOPRO, a competence center driven by the Royal Technical University in Stockholm, where we collaborate with several companies and the university itself to enhance bioprocessing techniques like cell culture processes. This consortium allows us to exchange ideas and tackle common challenges openly, enhancing our processes and solutions.

These collaborations are predominantly at the national and European levels, but we are actively looking to expand our alliances to include partners in the United States, which is still in the early stages. These strategic partnerships are vital as they foster innovation and allow us to stay at the forefront of technological advancements in the biopharmaceutical industry.

DA: One innovative area you mentioned is non-viral delivery systems.  How do you view their potential?

JH: Viral delivery systems received considerable attention in the development of gene therapies, but there remains a degree of skepticism about their widespread application beyond infectious diseases and vaccines. This opens the door for the development and integration of non-viral delivery methods, which I believe are crucial for diversifying treatment options. For example, our involvement developing and manufacturing a DNA vaccine as part of the OPENCORONA consortium included techniques like electroporation, which, while not a universal solution, illustrates the potential for physical methods of delivery.

We are exploring various non-viral approaches, such as outer membrane vesicles and lipid particles, which are less immunogenic and toxic and thus provide a potentially safer alternative to traditional viral methods. These innovations are promising not only because they offer a counterbalance to viral delivery’s limitations but also because they expand capabilities in biologics, making treatments more adaptable and less prone to causing immune reactions. As these technologies mature, they will become increasingly important to our strategy, complementing our existing suite of solutions and potentially leading the way in next-generation biopharmaceutical development.

DA: As the pharmaceutical industry begins to move toward more personalized and precision therapies, how is NorthX preparing to adapt to these emerging demands for smaller, more individualized batch production?

JH: NorthX is actively preparing for the shift toward more personalized therapies, particularly in cell therapy, which by nature requires a more tailored approach. For instance, while it isn’t itself a personalized therapy, the allogeneic cell therapy we produce for Mendus is manufactured with technology that aligns well with the personalized therapy model.

Additionally, we are assessing the potential for personalized therapies at our Matfors facility to ensure the rapid turnaround times that such treatments require. Looking ahead, it’s clear that the broader adoption of personalized therapies will necessitate a significant focus on cost reduction, both in clinical and manufacturing contexts. As the industry progresses, and potentially hundreds of cell and gene therapies become registered, managing and minimizing costs will become even more critical. This focus on cost-efficiency is likely to become an integral part of the innovation environment as we adapt our facilities and processes to accommodate these evolving demands.

DA: Sustainability is increasingly becoming a priority in biopharma. Can you discuss how NorthX is addressing sustainability in its operations and the importance of these efforts both for your customers and internally?

JH: Sustainability is a critical component of our operations and is deeply valued by our customers and staff.

We are committed to using only green energy and meticulously managing our waste, aiming to minimize our environmental footprint. We also balance the use of single-use systems with stainless steel in manufacturing to mitigate the environmental impact, particularly where single-use systems can be avoided.

Beyond environmental considerations, we emphasize social sustainability through various community engagement and educational initiatives. We actively participate in local and national educational programs, contributing to leadership development and fostering career opportunities for students, which aligns with our broader commitment to societal improvement.

Moreover, our approach to sustainability isn’t just about minimizing harm; it’s about actively contributing to the community and setting a standard for responsible business practices in the life sciences sector. I believe it’s essential to give back –– I see competence development as a circular process, both in regard to sharing experiences to support people in the beginning of their careers and fostering further scientific advancements. This holistic view on sustainability — spanning from green practices to social responsibility — is integral to our mission and is increasingly recognized as vital by our customers.

DA: To wrap things up, how do you see NorthX building upon your foundation and your current differentiators and continuing to evolve along with your customers?

JH: At NorthX, our philosophy is encapsulated by the phrase “Beyond CDMO.” We aim to be more than just a contract development and manufacturing organization; we focus on understanding our clients’ needs and growing alongside them throughout their development journey. This approach means we don’t just execute prescribed tasks; we engage deeply with our clients, fostering strong, lasting relationships whether the clients are large or small. This commitment to client-centric partnerships is what truly differentiates us in the industry.

Looking ahead, the biologics manufacturing landscape is poised for significant changes, driven by advancements in personalized medicine and other emerging modalities. We see ourselves continuing to be at the forefront of developing and manufacturing complex proteins and cell and gene therapies. Another area we are keenly focusing on is how our Innovation Hub and manufacturing capabilities can enable pandemic preparedness, ensuring that regions and countries are better equipped for future health crises, a direction that has gained momentum since the COVID-19 pandemic.

Overall, our goal is to lead in innovation and adaptability, staying ahead of industry trends and aligning our capabilities with the evolving needs of the biopharmaceutical sector.

A recent article in BioStock details how Lipum has begun the manufacturing process of SOL-116 for Phase II studies, in partnership with NorthX Biologics, a leading manufacturer of advanced biological drugs. SOL-116 is a monoclonal antibody that inhibits Bile Salt-Stimulated Lipase (BSSL), a protein crucial for sustaining chronic inflammation, initially targeting rheumatoid arthritis. The production of biological drugs is complex and costly, requiring precision and long lead times. Lipum chose NorthX Biologics as their contract manufacturer to reduce costs and lead times while maintaining high quality.

The collaboration involves NorthX Biologics handling the entire manufacturing process, including cell cultivation, scaling up, purification, quality control, vial filling, analytical work, and stability studies. The manufacturing process is expected to take 18 months and has already begun. NorthX Biologics has extensive experience in manufacturing biological drugs and offers a cost-effective, comprehensive solution for both the drug substance and sterile fill-finish. The partnership aims to bring this therapy closer to patients.

Read full article here.

The pharmaceutical and biotech industries are experiencing a paradigm shift that is redefining the roles and responsibilities of Contract Development and Manufacturing Organizations (CDMOs). Over the past few decades, these organizations have transitioned from being mere service providers to becoming essential partners in the drug development and manufacturing process. We at NorthX Biologics, a company that has been engaged in pharmaceutical manufacturing since 1963, have witnessed firsthand how the landscape has transformed—particularly in the realm of advanced biologics. This transformation is not just about scaling up operations; it’s about redefining relationships, expectations, and outcomes.

The shift from transactional to partnership-based models

Historically, CDMOs were seen primarily as external contractors—a means to an end for pharmaceutical companies that required additional capacity or specialized expertise. These relationships were often transactional, with clear boundaries between the client and the service provider. The CDMO was expected to deliver a specific product or service, with little room for collaboration beyond the agreed-upon terms.

However, as the industry has matured, it has become increasingly clear that this transactional model is insufficient to meet the demands of modern drug development, particularly in the context of advanced biologics. Today, there is a clear shift towards partnership-based models, where CDMOs and their clients work hand-in-hand throughout the entire drug development lifecycle—from early-stage development through to commercialization and beyond.

At NorthX Biologics, we have evolved from our roots in traditional medicine production to become a leader in advanced biological manufacturing. This evolution has been driven by several factors:

1. Increasing complexity of biologics: Unlike small molecules, which are relatively straightforward to manufacture, biologics are complex, large-molecule drugs derived from living cells. Their development and production require a deep understanding of biology, chemistry, and engineering, as well as a high degree of precision to ensure product stability and consistency across batches.
2. The rise of personalized medicine: Personalized medicine, including therapies tailored to individual patients’ genetic profiles, is becoming more prevalent. This requires a more flexible and responsive manufacturing process, where the CDMO must be able to quickly adapt to the specific needs of each therapy.
3. Demand for innovative therapies: The biotech industry is increasingly focused on developing cutting-edge therapies such as cell, gene, and mRNA therapies. These therapies require specialized manufacturing processes that go far beyond the capabilities of traditional small molecule production. As such, the role of the CDMO has expanded to include not just manufacturing, but also process development, regulatory support, and even post-market surveillance.

As a result of these factors, CDMOs like NorthX Biologics are no longer just service providers—we have become integral partners in the drug development process. This shift towards partnership-based models has profound implications for both CDMOs and their clients.

Advanced biologics: More than just a product

The production of advanced biologics is fundamentally different from the manufacturing of small molecules, and this difference has significant implications for the relationship between biotech companies and CDMOs.

Small molecule drugs are often straightforward chemical compounds that can be mass-produced using well-established processes. In contrast, biologics are complex drugs made from living cells. These drugs are not just products—they are processes. The manufacturing of biologics involves numerous steps, each of which must be carefully controlled to ensure the final product meets the necessary quality standards.

Moreover, biologics are highly sensitive to changes in their manufacturing environment. Even minor variations in the production process can lead to significant differences in the final product, which can affect its safety and efficacy. This complexity means that biologics manufacturing is not a one-size-fits-all service. Each biologic is unique, requiring a tailored approach to development and production.

This is where the traditional fee-for-service model, commonly used in small molecule production, falls short. In the world of biologics, you’re not just purchasing a product; you’re engaging in a collaborative process that involves ongoing dialogue, adaptation, and problem-solving between the biotech company and the CDMO. At NorthX Biologics, we have embraced this collaborative approach, recognizing that the successful development of advanced biologics requires a partnership mindset.

The importance of integrated services

In the rapidly evolving biotech industry, the ability to offer integrated services has become a key differentiator for CDMOs. As highlighted in the recent WittKieffer report (1), CDMOs that can provide end-to-end services—from process development to commercial-scale manufacturing—are increasingly in demand.

However, it’s not just about the breadth of services offered; it’s about how well these services are integrated and executed. A CDMO that can seamlessly coordinate activities across different departments and sites can significantly reduce the time and cost associated with drug development. This is particularly important in the early stages of development when processes and methods are still being refined.

For example, knowledge transfer is a critical component of the drug development process. Ensuring that insights gained during early-stage development are effectively communicated to the teams responsible for later stages can make the difference between hitting a critical milestone or facing costly delays. Similarly, close collaboration between the CDMO’s regulatory and manufacturing teams can help ensure that the final product meets all necessary regulatory requirements, thereby reducing the risk of delays during the approval process.

At NorthX Biologics, we have integrated our services across all stages of drug development and manufacturing, from early-stage process development to full-scale commercial production. This integrated approach has allowed us to provide our clients with the agility and expertise needed to navigate the complexities of biologics manufacturing, ultimately accelerating time-to-market for their products.

The leadership imperative

The shift from transactional relationships to partnership-based models also demands a new kind of leadership within CDMOs. As the WittKieffer report (1) points out, the traditional business-focused leadership model may no longer be sufficient to navigate the complexities of today’s market.

In the past, CDMO leadership was often focused on operational efficiency and cost control. However, as the role of CDMOs has evolved, so too have the demands placed on their leaders. Today’s CDMO leaders must be able to drive digital transformation, embrace sustainability, and manage the unique challenges posed by novel modalities like gene and mRNA therapies.

For biotech companies, this means choosing a CDMO partner with the right leadership—one that not only has the technical expertise but also the strategic vision to guide projects to success in a fast-paced, ever-changing environment. The right leadership can make the difference between a successful partnership and one that falls short of expectations.

At NorthX Biologics, our leadership team is committed to driving innovation and excellence in all aspects of our operations. With over six decades of experience, our evolution from traditional medicine manufacturing to advanced biologics production has been guided by a leadership ethos that prioritizes collaboration, agility, and strategic foresight. This leadership approach ensures that we are not only meeting the needs of today’s market but also anticipating the challenges and opportunities of tomorrow.

Conclusion: Choosing the right CDMO partner

As we look to the future, the role of CDMOs will continue to evolve, becoming even more integral to the success of drug development programs. For emerging biotech companies, selecting the right CDMO partner is not just about finding a provider with the right capabilities. It’s about finding a partner with whom you can build a long-term, collaborative relationship—one that is based on trust, shared goals, and a deep understanding of the complexities involved in biologics manufacturing.

In this new era, the choice of a CDMO is more critical than ever. It’s not just about what they can do for you today, but how they can help you navigate the challenges and opportunities that lie ahead. The right partner will not only help bring your product to market but will also play a crucial role in your company’s growth and success.

At NorthX Biologics, our history of innovation and commitment to excellence positions us as the ideal partner for biotech companies navigating the complex landscape of advanced biologics. With a legacy that spans over six decades, we understand that the path to success is paved with collaboration, expertise, and a shared vision for the future. As your CDMO partner, we are dedicated to helping you achieve your goals and drive meaningful impact in the world of healthcare.

(1) the-shifting-cdmo-leadership-landscape-wittkieffer-july-2024-1.pdf

NorthX Biologics is an established provider of process development and manufacturing services with expertise in the biologics used in vaccines, gene therapy and other advanced applications. Headquartered in Matfors in central Sweden, the company has been manufacturing biologics to GMP since 1992, with a proven track record of converting early-stage processes into manufacturing processes suitable for clinical applications and on into commercialization.

Read the article by clicking the link below.

In the dynamic and complex world of pharmaceuticals and drug development, the quest to find the right Contract Development and Manufacturing Organization (CDMO) often feels akin to searching for a life partner. As a person often facing and meeting the companies scouting for a CDMO I have heard this analogy so many times.  This kind of partner hunt it’s a journey filled with careful considerations, weighing options, and seeking that perfect match that aligns with your unique innovation needs. It is a in a way a “do we have the chemistry” test without pointing to the real type of chemistry.  This intricate process, surprisingly like finding a soulmate, requires more than just a scientific approach – it’s about understanding, compatibility, and a shared vision.

The romanticized idea of finding “the one” in a world brimming with potential partners parallels the challenges in the CDMO landscape. Just as there’s no single destined soulmate for each individual, the notion of one perfect manufacturing partner amidst a plethora of providers is equally unrealistic. In both scenarios, numerous potential partners could foster healthy, productive relationships. However, the selection process in the biotech industry involves less emotion and more objective evaluation (hopefully!), focusing on specific criteria that align with a company’s strategic goals.

Embarking on this ‘dating’ journey with CDMOs means engaging in a series of ‘dates’ – site visits, audits, and meetings that are crucial for understanding each other’s capabilities, goals, and values. At NorthX, we have  learned that compatibility, trust, and shared objectives are paramount for a successful partnership. Just like in personal relationships, these factors heavily influence the selection process. It takes a lot and  is not  easy to be able to show the true side, the naked truth in this dating game, but this is where transparency really has its purpose. As a customer you can set quite high expectations and as a CDMO representant  it means that you need to know your whole organization and trust your organizations to its full potential. Therefore being big is not always better in the CDMO space.

In the world of CDMO selection, it’s not just about the allure of state-of-the-art facilities or advanced bioreactors (a shiny new thing might of course be an extra plus). The real connection lies in the less tangible yet critical aspects like shared vision, trust, and effective communication. These elements form the heart of a strong partnership. For instance, financial compatibility and transparency are as vital in this relationship as they are in personal life, ensuring that your project’s budget aligns with the CDMO’s pricing structure.

The team behind the CDMO plays a role comparable to meeting a partner’s family. Their collective expertise, dedication, and collaboration will significantly impact the success of your project. This is especially true in the unique nature of biologics manufacturing, where precision, understanding, and a collaborative spirit are essential. The recent consolidation in the CDMO market, resulting in fewer but more diverse providers, has introduced new dynamics in the selection process. This change has led to providers acquiring additional capabilities (horizontal integration) or adding upstream or downstream services (vertical integration). These integrations promise simplicity and speed, but as a actor open to meet your perfect match you should sometimes instead  look for added technical benefits. Adding on also challenge the internal work structure and communication. This internal communication is so important and the mutual respect that different departments must display is crucial for an efficient scale up, scale out and transfer. So when you are dating, please dare to test the culture and climate of your CDMO,  do not satisfy with “ most convenient”. Be mindful of potential red flags indicating incomplete integration or separate operation of teams within a CDMO, but do not judge without asking about it. Even though a meeting with a “convenient”   person can lead to a flourishing long lasting relationship, it is quite rarely. You should not choose your life partner because this person was just the easiest one to get hold of or the only one still standing at three o’clock when you are walking home. Referrals is so underestimated, it should be the core if possible.  By using your existing network you add a layer of security, someone has already done the screening, and when it comes to CDMOs I would really recommend dating your best friends friend rather than blind dates ( meeting a stranger).

When you meet  “the family “ for the first time, you need to embrace all the members of the family.  A family dinner is never pleasant when some persons in the family do not really get a long, and if the family is very big the possibilities for this  kind of stressful family gatherings increases. Such nuances can reveal much about the internal culture and operational effectiveness of a CDMO.

During my years I have also encountered a lot of smaller biotech companies telling me about how they were not satisfied with their CDMO, but despite lack of trust and a lot of water under the bridges they choose to come back, year after year. This kind of bouncing back to your ex might seem like a really easy thing to do, you know what to expect and what you get, and you just started to hope that the ex had changed and became this prince/princess that you at first thought he/she was.  But honestly, bouncing back seldom gives you the “happily ever after”.  From a statistical point of view this reunition with your ex/former CDMO might have a 50/50 success rate,but it might also end up in you judging and he/she not being pleased with the way you communicate? This bouncing back can sometimes delay projects ( material to start clinical trial etc) more than actually moving and changing partner even though you always add time doing a new Tech Transfer.

In conclusion, selecting the right CDMO is akin to finding a long-term, committed life partner in the personal realm. It’s a decision that extends beyond the immediate, tangible aspects to the core of shared values, goals, and mutual understanding. This choice not only impacts your immediate project needs but also sets the stage for long-term success in the evolving world of therapeutic biologics. As you navigate this ‘dating’ landscape, remember that the right match is out there – a CDMO that understands your vision, aligns with your goals, and stands ready to join you in advancing healthcare innovation. Lets find the one, Lets Journey Together!

As the pharmaceutical and biotechnological industries are obliged to align their operations with Good Manufacturing Practice (GMP) guidelines, a unique set of challenges emerges for facilities tasked with producing non-GMP proteins. GMP is widely recognized as the gold standard for ensuring that products are consistently produced and controlled according to quality standards. However, in some cases, the production of non-GMP proteins (or “technical proteins), often required for research, industrial applications, or other non-clinical purposes, becomes a necessity.  At NorthX we serve both the non-gmp and GMP protein communities and place a strong emphasis on utilizing a strong Quality Management System, while at the same time respecting the process for each product.

Producing these proteins efficiently within a predominantly GMP-driven environment poses several challenges:

Segregation

Both GMP and non-GMP processes have their distinct sets of protocols and standards. Applying spatial, procedural or time-based segregation between GMP and non GMP products is essential. In cases where GMP manufacturing is the prevailing standard this will also stipulate how and what is needed to be done so ensure this segregation. Normally is not allowed to produce more than one pharmaceutical product at a time in a multipurpose facility and thorough product change over routines need to be in place to ensure the risk for carry overs and mix ups are minimized also contributing to the integrity and high quality of the non GMP protein manufactured.

Documentation dilemmas

GMP operations thrive on meticulous documentation. Every step, change, or deviation is carefully recorded. While non-GMP production doesn’t demand the same level of rigorous record-keeping, facilities must strike a balance. Too little documentation for non-GMP processes can lead to inefficiencies or inconsistencies, while over-documenting can unnecessarily tie up resources.

Training and personnel challenges

Staff trained predominantly in GMP protocols might find it challenging to switch gears for non-GMP production. The mindset and attentiveness required for GMP can be deeply ingrained, making it difficult to adapt to the more flexible requirements of non-GMP production.

Resource allocation

In a facility primarily designed for GMP production, resources – be it equipment, personnel, or space – are typically allocated with GMP requirements in mind. Efficiently producing non-GMP proteins requires a rethinking of these allocations without compromising GMP production.

Cross-contamination concerns

Even with segregation in place, the risk of cross-contamination always looms. It is therefore important that the superior quality system stipulates what operations is needed to be in place and what measures to take between batches. Ensuring that non-GMP proteins don’t compromise the quality of GMP products is paramount.

Regulatory scrutiny

Regulatory bodies, aware of the potential risks, might subject such dual-purpose facilities to heightened scrutiny. This can lead to more frequent inspections and audits, creating additional pressure on the facility to demonstrate clear demarcation and control over its two types of production.

Efficiently navigating the dual landscape

• While the challenges are significant, they’re not insurmountable. With strategic planning and a clear understanding of both GMP and non-GMP requirements, facilities can effectively navigate this dual Tailored Training Programs: Implement training modules specifically designed to address the nuances of working in a dual production environment.
• Robust Quality Management Systems (QMS): Implement a QMS that can adapt to both the rigorous demands of GMP and the flexibility of non-GMP.
• Regular Internal Audits: Periodically review and assess the efficacy of the separation strategies in place.

The expanding horizons of non-GMP technical proteins: A deep dive

In the biopharmaceutical arena, the importance of Good Manufacturing Practice (GMP) often takes center stage. However, beyond this GMP-centric world lies an equally essential category of proteins known as “industrial” or “technical proteins”. While they might not be used directly in therapeutic applications, they serve a myriad of functions that propel innovation and understanding in biotechnology. Let’s explore the expanding applications of these technical proteins.

1. Enzymes

Enzymes are the meticulous craftsmen of the biological world. They speed up chemical reactions, sculpt molecules, and construct or deconstruct various compounds. Their role in biotechnology is diverse:

• Biocatalysis: Enzymes, with their ability to catalyze reactions under mild conditions, offer eco-friendly alternatives in chemical synthesis. They’re used in producing biofuels, fine chemicals, and even pharmaceutical intermediates.
• Biomolecular Engineering: Restriction enzymes, ligases, and polymerases are the workhorses of genetic engineering, enabling DNA manipulation and amplification.
• Industrial Applications: From the enzymes in your laundry detergent that break down stains, to those in the food industry aiding cheese production, these proteins have a multitude of commercial applications.

2. Ligands

Ligands are molecules that can bind to other specific molecules. In biotechnology, protein ligands have invaluable roles:

• Affinity Chromatography: Protein ligands are used to purify other proteins or molecules. They bind to the target molecule, enabling its separation from a mixture.
• Diagnostics: Ligands play a central role in many diagnostic tests. For instance, they can capture specific biomolecules, indicating the presence or absence of a disease marker.
• Biosensors: Ligands are vital for the development of sensors that can detect specific molecules, from toxins in the environment to glucose in blood.

3. Analytical proteins

These proteins are indispensable for research, diagnostics, and quality control:

• Reporter Proteins: Proteins like Green Fluorescent Protein (GFP) are used to track gene expression, protein localization, and even monitor cellular events in real-time.
• Quality Control: Proteins employed in assays ensure that therapeutic products are consistent, potent, and free from contaminants.
• Drug Development: Proteins used in assays can screen potential drug candidates, assess their efficacy, or gauge potential side effects.

4. Structural and functional probes

To understand the complex dance of life at the molecular level, proteins are used as probes:

• Protein Crystallization: Some proteins can induce crystallization of other proteins or large complexes, aiding in their structural determination.
• Functional Assays: Proteins can be used to test the function of other molecules, be they drugs, other proteins, or even whole cellular pathways.

Championing the value of technical proteins

While the biopharma industry and regulatory bodies necessarily emphasize GMP due to its direct implication on human health, the role of technical proteins cannot be understated. They serve as the unsung heroes, facilitating innovation, preliminary testing, and foundational research.

As the industry continues to evolve, so will the applications of these non-GMP proteins. By understanding and championing their value, we can ensure that both the R&D and GMP spheres of biotechnology and pharmaceuticals continue to thrive and innovate hand in hand. The future is bright, and technical proteins will undoubtedly play a significant role in illuminating the path forward.

Have a technical protein in mind?  We would love to discuss with you how to move your project forward.  Please email us at contact@nxbio.com to learn more!

Current trends in ATMPs

This article is written by NorthX Biologics Senior Advisor Helena Strigård och Bio-works Technologies CEO Jonathan Royce.

Link to Article

The primary purpose of isolator technology is to prevent the transfer of undesirable elements such as vibration, noise, heat, electromagnetic interference (EMI), or contamination between isolated components or systems.

A wide range of techniques and devices are used to achieve isolation. These can involve the use of specialized materials, physical barriers, damping mechanisms, or complex engineering designs to achieve the desired level of isolation between components or systems. Isolator validation ensures that all components of the isolator meet pre-determined specifications for cleanliness, air quality, and other factors. 

In addition, product contact surfaces must be thoroughly cleaned and disinfected before use to prevent any potential contamination issues. Isolators are commonly used in various fields, including engineering, electronics, telecommunications, and science, where isolation is crucial for optimal performance or protection.

Here are a few examples of isolator technologies:

• Vibration isolators: These devices are designed to reduce or eliminate the transmission of mechanical vibrations between two objects. They are often used in applications where sensitive equipment, such as scientific instruments or electronic devices, needs protection from external vibrations.
• Noise isolators: Noise isolators, also known as soundproofing or acoustic isolators, are used to prevent the transmission of sound or noise between different spaces. They are commonly employed in buildings, recording studios, or industrial environments to minimize the impact of noise on occupants or to create soundproof environments.
• Thermal isolators: Thermal isolators are used to control heat transfer between two components or systems. They are often employed in electronic devices or systems to prevent thermal coupling and protect sensitive components from excessive heat. Thermal isolators can include materials with low thermal conductivity or specialized designs to minimize heat transfer.
• EMI isolators: Electromagnetic interference (EMI) isolators are utilized to reduce the transmission of electromagnetic waves or interference between components or systems. They are crucial in electronic equipment to prevent electromagnetic interference that can disrupt the normal functioning of sensitive devices or systems.
• Contamination isolators: Contamination isolators are specifically designed to maintain a controlled environment by isolating a particular space or process from the external environment. They are widely used in industries such as pharmaceuticals, biotechnology, or semiconductor manufacturing, where sterility testing in a clean environment is an essential procedure.
  

The Importance of Contamination Prevention

Preventing contamination is crucial in industries that require high levels of hygiene and safety, as even the smallest impurities can cause significant damage to products and people. Thereby, isolators are widely used in pharmaceuticals, biotechnology, and medical device manufacturing.

Isolators are essentially enclosed systems designed to isolate a process or product from its environment, thereby minimizing any risk of contamination. Their use ensures that no contaminants enter or exit the system during processing or packaging stages, helping maintain quality control and regulatory compliance. Isolation technology has become increasingly important in recent years due to rising standards for cleanliness and hygiene in pharmaceutical production environments.

By making sure isolation technology is properly implemented during pharmaceutical development, companies can confidently produce high-quality pharmaceutical products that meet stringent quality standards without worrying about potential contamination issues throughout their production processes.

The Role of Glove Boxes in Isolator Technology

Glove boxes play a critical role in maintaining a sterile environment and minimizing the risk of contamination during pharmaceutical production. They serve as containment isolators or aseptic isolators to ensure product quality and sterile manufacturing. Moreover, they provide microbiological control by preventing any outside contaminants from entering the isolated area.

Glovebox technology ensures product quality and operator safety during pharmaceutical production. They provide effective microbiological control by isolating hazardous materials from operators’ immediate surroundings while also allowing them to perform necessary tasks safely.

The effectiveness of this piece of equipment must be maintained with proper cleaning. Glove boxes must undergo a decontamination process to ensure they remain sterile between operations. This involves cleaning the entire system, including all surfaces inside and outside of the glove box and using appropriate cleaning agents. Regular cleaning validation ensures that all areas have been appropriately cleaned and disinfected before reuse.

Operator safety is another crucial aspect when it comes to glove boxes. Glove boxes isolate hazardous substances from operators’ immediate surroundings, protecting personnel from exposure to potentially dangerous chemicals or biological agents. Additionally, regular cleaning validation ensures that all areas have been adequately cleaned and disinfected before reuse.

Cleanrooms and Their Applications

Cleanrooms provide a controlled environment free from contaminants for sterile testing and manufacturing practices. The use of these advanced technologies allows for more stringent control measures to be implemented while maintaining regulatory requirements in check. Similarly to airtight bubbles, cleanrooms are filtered out to create an airtight barrier that is free of contamination. 

These controlled environments are perfect for sterile testing and manufacturing in various industries. Operators must enter through material transfer chambers to avoid direct contact with the entire cleanroom environment. Glove interventions are necessary when handling materials within the cleanroom, further reducing potential contamination risk.

Cleanroom technology is an attractive solution in various industries that require high levels of cleanliness, such as pharmaceutical development, biotechnology, and semiconductor manufacturing. Cleanroom design and operation must follow strict regulatory requirements to reduce contamination risk and ascertain consistent product quality. Maintaining the entire cleanroom’s integrity requires regular decontamination cycles using specialized equipment and techniques.

Isolator Technology in the Pharmaceutical Industry

The basic principles of the pharmaceutical industry demand that product requirements are stringent. Isolator systems play an integral role in achieving high-quality products while also complying with strict regulatory requirements to maintain product sterility assurance.

There are different types of isolators used for various applications within the pharmaceutical industry. One common type of isolator is a containment isolator, which protects operators from hazardous materials during handling and processing. Another type is an aseptic processing or sterile filling isolator used to maintain an aseptic environment during manufacturing processes.

Pharmaceutical isolators must comply with specific requirements such as ISO 5 classification for cleanrooms or grade A air quality levels, essential for sterility assurance. The isolation provided by these devices enables efficient production while maintaining product integrity, making them indispensable tools for pharmaceutical manufacturers.

Biotech Applications of Isolator Technology

Isolator technology has revolutionized the way sensitive materials are handled. In the biotech industry, isolators have enabled manufacturers to create high-quality products with precise specifications while protecting against contamination throughout the entire process – from development to distribution. Biotech applications of isolator technology include restricted access barrier systems (RABS) and aseptic manufacturing.

The biotech industry has greatly benefited from the advancements in isolator technology, as it provides a clean environment for processing critical substances. With this level of control, companies can create unique products with specific properties that traditional manufacturing techniques cannot achieve. This means that biotechnology companies can produce higher quality products than ever before, which is great news for consumers who rely on these products for their health and well-being.

Food Production and Isolator Technology

In the food production industry, isolators ensure that products meet strict quality standards. One of the main benefits of using isolator technology in food production is preventing cross-contamination, which can occur when different types of food come into contact with each other during processing or packaging. Isolators provide a barrier between different stages of production by ensuring that each stage remains isolated from one another.

Isolator gloves are also an important part of this technology as they allow workers to handle food products without coming into contact with them directly. This helps to prevent any potential contamination from human contact while working inside the isolator environment. Additionally, flexible wall isolators can be customized to fit specific needs, making them ideal for use in various areas within a facility.

Bio-decontamination is also essential, as it ensures that any bacteria or viruses present on surfaces are eliminated before work begins inside the enclosure. This involves using chemical agents or radiation sources such as UV-C light for the sterilization of surfaces within the isolator environment. By eliminating harmful microorganisms, companies can produce safe and high-quality products for their customers.

Isolator Technology in Nuclear Power Plants

Isolator technology is used in nuclear power plants to maintain a clean, controlled environment that prevents radioactive products from escaping into the atmosphere. Its ability to create a controlled environment with minimal intervention helps reduce human error and ensures maximum protection for both workers and the surrounding ecosystem

Isolator technology works by controlling the internal air pressure within a sealed chamber, which creates a positive pressure differential that prevents contaminants from entering. In addition, isolators can be equipped with various interventions such as gloves or robotic arms that allow workers to manipulate equipment and materials while maintaining isolation. This allows workers to perform tasks inside the chamber without being exposed to radiation or other harmful substances.

Isolation technology capabilities are strictly regulated by limit values for radioactive exposure set by national and international organizations. If any breach of isolator integrity and contamination were to happen, decontamination agents must be applied to neutralize any hazardous substances before they escape into the environment.

Advancements in Isolator Technology

Isolator technology has come a long way from traditional cleanrooms, providing more efficient solutions for contamination control in pharmaceutical manufacturing. The capabilities of isolation technology add an extra layer of protection against environmental factors, humidity control, and oxygen control. Additionally, modern ergonomic designs help reduce worker fatigue and increase productivity during extended periods of use.

Advancements in this technology rely on aseptic practices that minimize human intervention during production processes. This reduces the likelihood of microbial contamination and ensures that products meet strict quality standards. Risk analysis is also important and designs must take into account all potential risks associated with the process to minimize any negative impacts on performance or safety. As industries continue to push for higher standards in manufacturing practices, we can expect further improvements in isolator technologies to contribute towards achieving these goals.

The Future of Isolator Technology in Various Industries

One of the most promising areas for isolation technology is the pharmaceutical manufacturing environment, where contamination risk is high due to microbial bodies. Isolation technology not only leads to a reduction of contamination risk but also allows for a more controlled production process.

Another area where isolation technology shows great promise is in the aseptic filling processes. These involve filling sterile products into containers without exposing them to external contaminants. Isolators provide an ideal environment for this type of process because they can maintain a sterile environment while still allowing workers access to the product through glove interventions or other openings.

Overall, the future of isolator technology looks bright as it continues to evolve alongside advances in industry needs and standards. From the reduction of contamination risk in pharmaceutical manufacturing environments to facilitating safer aseptic filling processes, isolators offer numerous benefits that make them an essential component in many industries’ workflows today and well into tomorrow’s world.ç

Pharmaceutical development services

In today’s rapidly evolving world, the need for precision, safety, and controlled environments has become increasingly important across a multitude of industries. From pharmaceuticals to biotechnology, advanced research laboratories, and even high-tech manufacturing processes, the demand for technologies that protect sensitive materials and personnel is paramount.

At NxBio, we possess the technology and expertise to successfully handle the pharmaceutical product manufacturing process. We specialize in all aspects of developing early-stage processes into manufacturing processes, including making use of the best isolator systems and making sure isolator validation is properly leveraged. Together, we can create a potent product for patients that makes the best out of the advantages of isolation technology.

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DN 22 Maj 2023