4 Insights On CDMO Relationships From A Vaccine Developer
By Tim R. Hirst, Ph.D., chairman and CEO, GPN Vaccines
GPN Vaccines is developing a broad-spectrum vaccine against Streptococcus pneumoniae, which causes life-threatening pneumonia, meningitis, and sepsis, as well as otitis media in children. Up to 2 million deaths worldwide are attributed to S. pneumoniae each year, killing more children than AIDS, malaria, and tuberculosis combined. The best vaccine available only protects against 20 of the 100 known strains. GPN Vaccines is therefore developing a novel whole-cell vaccine to provide adults and children with broad-spectrum protection.
After achieving favorable preclinical results, the most substantial hurdle we faced was to develop an optimized and reproducible manufacturing process for our product to be used for clinical trials. We realized a good CDMO partnership was the only path to successfully manufacturing our therapeutic.
After vetting multiple CDMOs, we selected a strategic partnership with BioCina, a company that understood our vision and the difference between simply manufacturing and actually developing a manufacturing process. As the developer of the pneumococcal vaccine, we know more than anyone else about how to grow the vaccine strain in a research laboratory, but producing it at scale and to cGMP standards required the expertise of a CDMO. From the beginning, we embarked on a collaborative process with BioCina’s research and development team to develop, optimize, and refine our manufacturing process.
Here are four critical insights we gathered along the way that might inform your CDMO selection criteria and manufacturing process.
1. The Product Is The Process
In the development of any biologic, your product is only as good as the process that produces it. Put simply: if you can't clearly define and control the manufacturing process, you risk creating a product that is not reproducible. Translating development into a robust and reproducible manufacturing process is a real challenge. A CDMO must be structured to provide both the appropriate technical capability and be an extension of our scientific team. That's essential when selecting a CDMO.
This is where a CDMO's technical capability is critical. In our case, BioCina worked hand-in-hand with our development team to ensure the tech transfer occurred efficiently and that the appropriate process was developed to scale production. Moreover, a solid manufacturing process must be transferable. Once formulated, you should be able to manufacture your product anywhere at scale.
2. Be Aware Of Your Requirements And Constraints
The development of a pneumococcal vaccine required us to work with an organism that requires specialized handling procedures at a laboratory with a specific biological safety classification. At the outset, this limited the number of qualified CDMOs available. It also necessitated a CDMO with a very clear and strong foundation in regulatory affairs and quality assurance.
We also knew that our vaccine would require optimization of the filtration procedures used in the downstream manufacturing process. Our CDMO would need specific expertise around filtration optimization.
As part of our CDMO vetting process, our auditing team assessed each potential CDMO's quality management systems, facility classification, specific expertise, and regulatory compliance. One criterion that may be surprising to many is finding a partner that has the capacity to meet time-sensitive timelines.
We also discovered that on-site audits are a critical part of the process. By being mindful and honest about our product's constraints and requirements, we were able to weigh each CDMO's competencies against our needs.
One moment that remains memorable is the day our auditor returned from an audit of the BioCina facility and reported, "This is a gold standard quality management system and regulatory affairs group." Feeling we were partnering with one of the highest-quality CDMOs they had seen anywhere in the world gave us the confidence that was essential in setting the foundation for effective collaboration.
3. Build A Collaborative Partnership
Our involvement didn't end once we made a decision to partner with BioCina. Collaboration is key to any relationship, and we worked jointly to devise a manufacturing process, optimize it, adjust it, and adopt a solution to produce a suitable vaccine for clinical use. Throughout the course of the project, our CDMO produced several R&D batches of our vaccine and shipped them to us for quick analysis. This information was used to improve and adjust the manufacturing process over multiple iterations.
The success of our partnership was underpinned by shared project management, as opposed to a simple contractual agreement. In the end, the partnership proved essential to the rapid formulation of a manufacturing process for our vaccine. Your CDMO should be as invested in the success of our program as you are.
Speed, agility, and on-time delivery were important to us and had to be priorities for our CDMO partner.
4. Time Is Money. Budget Both Carefully.
Developers and CDMOs know that time and money are precious. Developers want to advance their product as fast as possible, and CDMOs want to start manufacturing as soon as they can (that's their business model, after all). However, the path forward for both is not always the same.
When budgeting time and money, communication is key. Early in the partnership, the focus should be on what needs to be done quickly and what requires more careful attention. Then allocate resources appropriately. Once we decided to work with our chosen CDMO, we felt a sense of urgency to get the manufactured product tested in toxicology studies to show it was safe and ready to progress to a clinical trial. BioCina understood our urgency and moved just as fast. That's not to say we rushed into it: we worked in the most efficient way possible to leverage time and money to reach our goals. This type of relationship doesn't happen by default: budgets and expectations need to be established up front, and they need to be revisited continuously throughout the project.
Be sure to confirm your organization and your CDMO partner are aligned on the bigger picture goal and project management. Carefully assess potential partners, foster collaboration, be honest about your requirements and constraints, and work closely with your CDMO to establish a budget, and you'll be well on your way to success.
About The Author:
Tim R. Hirst, Ph.D., is the chairman and CEO of GPN Vaccines, a biotechnology company based in Australia.