Author: Martina Ferneman

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!