What’s hot and what’s not in ATMP? Insights from service providers, investors, and academics at the 2024 BIO-Europe conference in Stockholm.
BIO-Europe celebrated its 30th anniversary in Stockholm, Sweden, on November 4–6, 2024, bringing together over 5,000 delegates from around the world.
Post-pandemic, life science companies face funding challenges, emphasizing the need for solid data over visions. The Nordic region, though small individually, thrives through innovation and collaboration, with promising developments in manufacturing and funding strategies. Trends in CGT, such as diversification beyond mRNA and integrating AI for efficiency, are discussed in this article. Challenges in manufacturing and affordability remain critical. Despite hurdles, optimism persists, with Nordic companies leveraging global partnerships to remain a hotspot for CGT innovation.
Read the full conference report by Helena Strigård, Roger Lias and NorthX Biologics’ very own Eva-Karin Gidlund, in Cell & Gene Therapy Insights here.
Sweden holds a unique position in life sciences and has, for decades, been a leading nation in research and innovation. With renowned universities, colleges, and a dynamic startup environment, Sweden has established itself as an innovation engine in the field. But it is not only in research and development where Sweden excels. We also have a long and successful tradition of pharmaceutical manufacturing, both for companies’ own products and through contract manufacturing. This gives us a unique standing as a production hub in the life sciences sector.
The government’s new life science strategy highlights pharmaceutical production alongside innovation. This is an important acknowledgment of the role high-tech manufacturing plays in Sweden’s competitiveness. The production of pharmaceuticals and advanced therapies, known as ATMP (Advanced Therapy Medicinal Products), contributes not only to export revenues but also strengthens our national preparedness and self-sufficiency. Nowadays, it is no longer necessary to take innovations abroad; in Sweden, we have established innovation environments such as Testa Center, NorthX Innovation Hub, and CCRM Nordic that bridge innovation to industrial production domestically.
An important part of Sweden’s GDP
The pharmaceutical industry already plays a significant role in Sweden’s economy. According to the industry association Lif, pharmaceutical exports continue to be a strong driver of the Swedish economy, creating a positive trade surplus. To maximize the value of life sciences in Sweden, it is crucial that the entire value chain is present – from research and development to the production and commercialization of pharmaceuticals, therapies, and medical devices. However, this requires creating conditions for further investments in manufacturing in Sweden.
A strong production sector can also stimulate other areas of life sciences, such as clinical trials and research. Simultaneously, domestic pharmaceutical production provides Sweden with increased resilience in situations where global supply chains risk being disrupted, as highlighted during the pandemic.
Securing competence – a key issue
To maintain and develop Sweden’s competitiveness as a production hub in life sciences, securing skilled labor is essential. The manufacturing industry needs dedicated, meticulous, and knowledgeable employees. But how do we get more people to view life sciences manufacturing as an attractive career path? Tomorrow’s workforce is not only looking for a job but also for opportunities for growth, flexibility, and purpose.
One step in the right direction would be to establish and further develop educational programs closely linked to the industry’s needs. Examples include apprenticeship or trainee programs where the government and private sector collaborate. Such programs could lower the barrier for newly educated individuals to enter the workforce while ensuring the industry has access to the required skills. A clear and well-structured pathway into the labor market also makes Life Sciences more appealing to students when choosing their education.
To further strengthen the availability of skilled workers, Sweden should actively work to attract educated professionals from other countries. It should be easy to move to Sweden and stay here, with support for relocation, housing, and language training at the appropriate level. Additionally, resources should be available to support partners and families, contributing to a safe and welcoming environment for international talents. This is crucial for ensuring Sweden can compete for the best global talent.
A holistic approach that creates value
With the entire value chain in Life Sciences – from research to high-tech manufacturing – we can continue to create jobs, tax revenues, and increased knowledge. This results in products and services that improve public health and strengthen Sweden’s role as a global leader in life sciences. However, achieving this requires collaboration between the government, educational institutions, and industry to ensure we do not lose our competitive edge. Let us build on Sweden’s strengths and secure a sustainable future as a production country in life sciences.
The pharmaceutical industry is experiencing a rapid transformation as advanced biologics – viral vectors, recombinant proteins, plasmid DNA, and cell and gene therapies – take center stage. With over 14,800 active biologics innovation programs in development, including monoclonal antibodies, viral vaccines, and gene therapy vectors like AAVs and adenoviruses, the demand for specialized biologics contract development and manufacturing organizations (CDMOs) is soaring. Plasmid manufacturing remains integral to these innovations, underpinning gene therapies, DNA vaccines, and mRNA manufacturing.
Manufacturing these advanced therapies is a highly complex process that requires careful control over production platforms and scale-up strategies. For viral vectors, the process begins with a master cell bank (MCB), containing cells such as HEK293 or Vero that have been optimized for viral vector production. The viral seed stock, a small, well-characterized batch of virus, is used to infect the MCB during upstream processing. The viral particles are then expanded in either suspension bioreactors or adherent systems like the iCellis500 platform. This is followed by cell lysis, endonuclease treatment, and depth filtration to remove debris. Tangential flow filtration (TFF) further concentrates the viral product, while chromatography ensures the removal of impurities during purification. The process culminates in formulation and aseptic fill-finish, ensuring the product meets regulatory and safety requirements.
Recombinant protein services and plasmid manufacturing
For recombinant proteins, microbial systems such as E. coli or mammalian cell lines like CHO are commonly used. Microbial production often leverages transient expression, where plasmids containing the gene of interest are introduced into bacterial cells for rapid protein synthesis. In mammalian systems, cell banks provide stable production platforms where cells are expanded, transfected with the target gene, and induced to produce recombinant proteins. After fermentation or cell culture, purification involves ultrafiltration, diafiltration, and chromatography to isolate the desired protein, followed by formulation and fill-finish.
Plasmid DNA, essential for gene therapies and mRNA vaccines, is manufactured using microbial fermentation systems. A carefully selected host strain of E. coli is used to amplify plasmid DNA during fermentation. After cell harvest and lysis, the plasmid is separated from host DNA and proteins through filtration, chromatography, and buffer exchange processes. The purified plasmid DNA is then formulated and filled aseptically under GMP conditions. NorthX Biologics has excelled in this space, offering scalable plasmid DNA production, ensuring a seamless transition from research-grade material to clinical GMP batches.
Biologics CDMO Services
NorthX Biologics has emerged as a leader in the advanced biologics space by integrating these complex manufacturing processes into streamlined, end-to-end solutions. Our capabilities span viral vectors, recombinant protein services, plasmid manufacturing, and cell therapy services. In cell therapy manufacturing, we leverage allogeneic or autologous cell banks, expanding cells in controlled GMP cleanrooms. Cells undergo activation, differentiation, and harvest, followed by aseptic filling and cryopreservation to ensure product viability.
These manufacturing capabilities are supported by NorthX Biologics’s expertise in process development, regulatory compliance, and analytical testing. By offering upstream process optimization, purification, and aseptic fill-finish under one roof, NorthX Biologics significantly reduces timelines while ensuring product quality.
The success of NorthX Biologics’s approach is demonstrated in real-world collaborations. During the OPENCORONA project, NorthX Biologics rapidly produced GMP-grade plasmid DNA for a SARS-CoV-2 vaccine, meeting strict quality and regulatory standards. In viral vector manufacturing, NorthX Biologics enabled HOOKIPA Pharma to scale a novel immunotherapy product to 200L using their transient expression processes and robust purification techniques. For Mendus, NorthX Biologics established GMP cell therapy manufacturing capabilities within just eight months, ensuring a smooth tech transfer and rapid scale-up for clinical production. Similarly, in collaboration with Abera Bioscience, NorthX Biologics supports the GMP manufacturing of outer membrane vesicles (OMVs), leveraging microbial processes to produce these naturally occurring particles for innovative vaccines.
Aseptic fill-finish and analytical expertise
To meet growing market demands, NorthX Biologics has invested in two European facilities equipped for microbial and mammalian production. These sites include BSL2 and BSL3 capabilities, supporting a range of biologics platforms. Our aseptic fill-finish services adhere to Annex 1 regulations, providing the highest level of assurance for clinical and commercial products. Additionally, NorthX Biologics’s in-house analytical expertise ensures rigorous quality control, from biologics process development and in-process monitoring to release testing and stability studies.
As advanced therapies continue to evolve, the role of biologics CDMOs in enabling efficient and scalable manufacturing becomes increasingly critical. NorthX Biologics stands out as a true partner in innovation, seamlessly integrating cell banking, seed stock preparation, transient expression systems, and robust purification and analytical technologies to support pharmaceutical innovators. By combining decades of GMP experience with cutting-edge manufacturing capabilities, NorthX Biologics is well-positioned to deliver life-saving therapies faster and more efficiently, helping patients worldwide benefit from the next generation of biologics.
NorthX Biologics’ investor and CEO of Flerie, Ted Fjällman made a guest appearance in a recent episode of Värdeskaparna, a podcast taking the audience behind the scenes in the private equity world.
During the podcast, Ted delves into the biotech industry’s current trends and future directions, sharing his valuable insights and experiences.
Janet Hoogstraate, the CEO of NorthX Biologics, recently appeared in an episode of Q-podden, a podcast on manufacturing, quality and corporate culture in life science.
Janet discusses the latest trends and innovations in the biotech industry, offering her unique perspective and expertise. It’s definitely worth a listen for anyone interested in the field!
On behalf of the Swedish Ministry for Foreign Affairs and Gavi, the Global Vaccine Alliance, NorthX Biologics’ CEO Janet Hoogstraate participated in an important roundtable on “Leveraging Technology and Innovation to Ensure Every Child is Vaccinated” on December 10, 2024.Joined by other Swedish companies and international organisations with experiences in pioneering innovations in technology and sustainability, together they explored how to contribute to reaching the 14.5 million children in the world who still lack vaccines.
Read Janet’s statement below.
Your excellencies, Ladies and Gentlemen,
It is an honor to join this important conversation about leveraging technology and innovation to ensure every child is vaccinated. At NorthX Biologics, we are deeply committed to driving change and contributing meaningfully to this global effort.
First, scaling up vaccine manufacturing processes is at the heart of what we do. By leveraging cutting-edge technologies and robust expertise, NorthX Biologics is well-positioned to increase production capacity for both new and existing vaccines. This ensures rapid response to global health needs.
Second, we believe in the power of technology transfer to low- and middle-income countries. Establishing local manufacturing hubs is crucial for self-sufficiency and long-term vaccine security. We are ready to collaborate with partners to transfer our expertise and support the creation of regional production capabilities. We are proud of our history of working on scaling up and manufacturing of clinical trial material for a more affordable polio vaccine, having been part of two projects supported by the Bill & Melinda Gates Foundation.
Third, capacity building is essential. At NorthX Biologics, we prioritize training staff in Good Manufacturing Practices (GMP), biotechnology, and advanced analytical techniques. By equipping local teams with the skills they need, we help build sustainable ecosystems for vaccine development and production.
Fourth, we recognize the urgent need for cost-effective solutions. By working to redesign and redevelop vaccines—for instance, making them more stable so they can be transported at room temperature rather than refrigerated—we can make vaccines more accessible and reduce logistical challenges. We are currently a partner in an oral cholera vaccine project collaborating with professor Jan Holmgren and the International Vaccine Institute. These partnerships demonstrate our commitment to advancing vaccine access and global health equity.
Finally, our capabilities extend to manufacturing new vaccines and quality control analyses to ensure their safety, quality and consistency.
NorthX Biologics is not just a manufacturer; we are a partner in innovation, committed to finding creative solutions to global challenges. By collaborating with governments, non-profits, companies and other stakeholders, we can collectively work towards a future where no child is left behind in receiving life-saving vaccines.
I look forward to exploring new approaches and opportunities for collaboration with all of you. Together, we can ensure a healthier, brighter future for every child.
Based on a presentation given by Thomas Eldered at the PharmaOutsourcing event, Stockholm, Sweden, December 2024.
From vertical integration to decentralization
The pharmaceutical industry has undergone a seismic shift over the last several decades, transitioning from a vertically integrated model to a decentralized ecosystem of partnerships and specialized services. This transformation has ushered in what many now recognize as the CDMO era – an age defined by outsourcing, collaboration, and rapid innovation. For investors, this evolution presents a unique opportunity to engage with a sector that is both resilient and dynamic.
Historically, pharmaceutical companies operated under a fully integrated model, where they controlled every aspect of drug discovery, development, and manufacturing. This model dominated for much of the 20th century, providing developers with full control over their intellectual property, supply chains, and manufacturing processes. However, as the complexity of drug development grew, the limitations of this approach became apparent. The cost of maintaining in-house expertise for increasingly specialized tasks, coupled with the inefficiencies inherent in such a broad operational scope, began to erode the model’s viability.
The late 1990s and early 2000s marked a pivotal turning point. Advances in biotechnology during this period brought about the “biotech revolution”, shifting the industry’s focus toward complex biologics, including monoclonal antibodies, cell therapies, and gene therapies. These modalities required specialized knowledge and infrastructure that many pharmaceutical companies lacked. Simultaneously, the competitive pressure to reduce time-to-market and development costs became more pronounced. These factors paved the way for the rise of Contract Development and Manufacturing Organizations (CDMOs).
The 2000s saw the rapid proliferation of CDMOs, with companies like Covance, Charles River, and Recipharm emerging as major players in the field. These organizations offered a compelling value proposition: they provided access to specialized expertise and state-of-the-art facilities, enabling pharmaceutical firms to focus on core competencies like research and commercialization. By outsourcing development and manufacturing tasks, companies could reduce their risk in operating manufacturing facilities running half empty, and thereby reduce their capital expenditures, manage risks more effectively, and accelerate product development timelines.
A new era in pharmaceutical development
This shift toward outsourcing marked the beginning of a new era in pharmaceutical development. The model of the “virtual organization” emerged, where biotech startups and even mid-sized firms operated with minimal in-house teams, relying instead on an extensive network of external partners. This approach proved particularly well-suited for early-stage companies, which often faced resource constraints but needed to navigate complex regulatory and technical challenges.
By 2010, the CDMO sector had become an integral part of the life sciences ecosystem. The global CDMO market was expanding rapidly, driven by several key factors. First, the demand for biologics and personalized medicine continued to grow, requiring specialized manufacturing capabilities. Second, the industry faced increasing regulatory scrutiny, necessitating advanced analytical and compliance expertise. Third, the globalization of pharmaceutical supply chains highlighted the need for flexible and scalable manufacturing solutions.
Today, the CDMO industry is a cornerstone of pharmaceutical innovation. The market is characterized by a high degree of specialization, with firms offering tailored solutions across various modalities, including small molecules, biologics, and advanced therapies. This specialization is complemented by a trend toward consolidation, as larger CDMOs acquire smaller, niche players to enhance their capabilities and geographic reach.
In the late 1990s, Thomas Eldered experienced a pivotal moment during a board meeting at a mid-sized pharmaceutical company. The team, juggling the dual challenges of R&D and manufacturing, faced mounting pressure to deliver a promising biologic. One executive’s comment, “We’re scientists, not manufacturers,” struck a chord with Thomas, highlighting the industry’s struggle to manage increasingly complex tasks in-house.
This realization mirrored broader challenges across the pharmaceutical sector. Over the following years, Thomas saw how outsourcing to specialized CDMOs became a game-changer. These partnerships allowed biotech companies to focus on innovation while tapping into the advanced infrastructure and expertise of their collaborators.
In the early 2000s, Thomas witnessed the success of this model firsthand when a small biotech client outsourced its manufacturing to a budding CDMO. The move halved development timelines and helped the company navigate regulatory hurdles, showcasing the real potential of these partnerships.
Today, CDMOs are seen as a cornerstone of the pharmaceutical ecosystem. In areas like cell and gene therapy, outsourcing has become essential for staying agile and precise, reflecting the industry’s shift from working in isolation to embracing collaboration.
NorthX Biologics: beyond traditional CDMO services
Within this competitive landscape, NorthX Biologics has emerged as a unique and innovative player. Unlike many of its peers, NorthX Biologics positions itself not just as a traditional CDMO but as an “Beyond CDMO” operating an Innovation Hub offering a range of services designed to support the development and manufacturing of advanced therapies. The company history reflects its deep roots in pharmaceutical manufacturing. Established as the Statens Bakteriologiska Laboratorium (SBL) in 1909, the organization evolved over decades, eventually transitioning into NorthX Biologics in 2021.
One of NorthX Biologics distinguishing features is its focus on advanced therapies, such as cell and gene therapies, mRNA technologies, and personalized medicines. For example, the company has played a critical role in several high-profile projects, including the rapid development of clinical trial materials for novel immunotherapies. In one notable case, NorthX supported HOOKIPA Pharma in scaling up the manufacturing process for a viral vector product, enabling the company to meet tight clinical trial timelines. This project, completed within 18 months, exemplifies NorthX’s ability to deliver innovative solutions under challenging conditions.
Another hallmark is its emphasis on collaboration. The company works closely with clients to understand their unique needs, leveraging its expertise to develop tailored solutions. This collaborative ethos is evident in its work with Mendus, a clinical-stage immuno-oncology company. Together, they established a scalable manufacturing process for Mendus’ lead cell-based therapy, overcoming significant technical and logistical challenges.
When compared to industry giants like Lonza and Catalent, NorthX Biologics differentiation lies in its agility and focus on emerging modalities. While larger CDMOs excel at providing broad, end-to-end solutions, the company offers a more specialized and nimble approach. This is particularly valuable for biotech startups and smaller pharmaceutical firms, which often require customized support to navigate the complexities of advanced therapy development.
CDMOS: a de-risked investment opportunity
The investor perspective on the CDMO sector is overwhelmingly positive. CDMOs represent a de-risked investment opportunity, as their business models are inherently diversified. By serving multiple clients across various therapeutic areas, CDMOs can mitigate the risks associated with individual product failures. Additionally, the sector benefits from strong, long-term societal trends, including an aging population, rising healthcare expenditures, and the growing prevalence of chronic diseases.
For investors, companies like NorthX Biologics signal a forward-thinking approach to pharmaceutical development. The combination of advanced capabilities, collaborative ethos, and focus on innovation positions it as a leader in the rapidly evolving CDMO landscape. The company’s emphasis on advanced therapies aligns with the broader industry trend toward personalized medicine, offering significant growth potential in the years ahead.
Continued growth and transformation
Looking to the future, the CDMO industry is poised for continued growth and transformation. One key trend is the increasing integration of digital technologies, such as artificial intelligence and automation, into manufacturing processes. These technologies have the potential to enhance efficiency, reduce costs, and improve product quality. Another trend is the regionalization of manufacturing capabilities, driven by geopolitical considerations and the need to mitigate supply chain risks.
The pharmaceutical industry is also moving toward a more collaborative ecosystem, where partnerships between CDMOs, biotech firms, and academic institutions play a central role in driving innovation. This shift is particularly evident in the advanced therapy space, where the complexity of products necessitates close collaboration between stakeholders.
In conclusion, the rise of the CDMO era represents a profound shift in the pharmaceutical industry. This transformation has been driven by the need for specialization, efficiency, and collaboration, creating new opportunities for innovation and growth. Companies like NorthX Biologics exemplify the potential of this new paradigm, offering tailored solutions that enable clients to navigate the complexities of advanced therapy development. For investors, the CDMO sector offers a compelling opportunity to engage with a dynamic and resilient industry that is shaping the future of healthcare. As the pharmaceutical landscape continues to evolve, the role of CDMOs will only grow in importance, making this an exciting time for both industry stakeholders and investors alike.
Thomas Beck, the Chief Quality Officer (CQO) at NorthX Biologics, was recently featured in an episode of Q podden, a podcast on manufacturing, quality and corporate culture in life science.
In this podcast, Thomas shares valuable insights into the latest advancements and challenges in the field of biologics. It’s a must-listen for anyone interested in the biotech industry!
In this episode of the Molecule to Market podcast, NorthX Biologics CEO Janet Hoogstraate was invited to discuss the implications of integrating Catalent’s capabilities into Novo Nordisk’s operations and what it means for the broader CDMO sector, in a panel together with other industry experts:
Dirk Lange, CEO at Pyramid Labs
Brett Alderson, President & Site Leader at NovaCina
John Cameron, Director, Global Injectables Platform at Corden Pharma
Podcast host Raman Sehgal discusses the pharmaceutical and biotechnology supply chain with Dirk, Brett, John & Janet, focusing on:
Maximizing GLP-1 manufacturing capacity: Discussing Novo Nordisk’s recent acquisition of Catalent’s manufacturing facilities to bolster GLP-1 production capabilities
Industry consolidation: What this acquisition means for the pharmaceutical outsourcing industry and its impact on competition among CDMOs
Meeting surging demand: Exploring how this move positions Novo Nordisk to respond to the rapidly increasing demand for GLP-1 receptor agonists, like those used in diabetes and obesity treatments
Strategic manufacturing: The implications of integrating Catalent’s capabilities into Novo Nordisk’s operations and what it means for the broader CDMO sector
With GLP-1 drugs at the forefront of diabetes and obesity treatment, Novo Nordisk’s strategic acquisition of Catalent aims to strengthen its supply chain and boost production capacity to meet global demand. Our guests provide in-depth insights into how this acquisition could shape the future of drug development and outsourcing across the industry.
Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.
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.
