How to select a CDMO for a biopharmaceutical project or program.
Outsourcing as a business model within the Life Science-industry is growing year by year. Choosing the right contract development and manufacturing organization (CDMO) has become an important factor for the success of drug product development. But finding, selecting, evaluating and initiating a CDMO partnership may be challenging. In addition to obvious requirements relating to e.g. regulatory compliance, quality and capacity, there are several points to consider when choosing the right partner. Here, Hans Arwidsson, the CEO of Eurocine Vaccines, describes their process and checklist in selecting a CDMO partner for their novel vaccine candidate against Chlamydia trachomatis.
1. Track record
A CDMO needs to have both technical and scientific knowledge to understand your molecule and project. For us, it was important to find a CDMO who understands the needs of complex projects and has extensive experience in process development and vaccine manufacturing. Ask about the track record with similar projects. The years of experience, the number of projects and the number of batches they have produced, are powerful indicators of experience.
2. Added value and perspective
Every drug development project is different. Therefore, the expertise of the people who will be working on your project is of utmost importance. Impactful teams will be able to come up with solutions and solve any challenges or issues. CDMO expertise takes years to build. A high retention rate of employees is a good indicator because it ensures that the competence has remained within the company. A high number of people with higher education is another good indicator of the expertise within the CDMO.
3. Support to your development process
Think about the supply chain and the value chain that the CDMO covers. We preferred a One-Stop-Shop CDMO that offers services from early development to fill and finish. It saves us a technology transfer, which would have been necessary if the process development had been done in one place and the production for clinical trials (GMP) in another. In addition to being convenient, it is cost-effective to have everything under the same roof. Qualified Person approved release for clinical studies makes the service chain complete.
4. Culture and communication
A good question to ask yourself is: “how does it feel to discuss your project details with them?” Do you have a feeling that you understand each other and that you are being heard? A good culture fit means that the CDMO will be aligned with your mission and purpose. Moreover, it is important to think about the relationship you want to have with the CDMO. A partner of similar size can help to secure your project with a higher priority and resources. A balanced relationship with a CDMO removes the risk of being overrun by bigger clients when reserving the resources of the CDMO.
5. Attentiveness and agility
Look at how the CDMO handles partnership and relationships. When people are the primary focus, the organization will be agile, pro-active in communication, and focused on delivering client satisfaction. We chose a CDMO who gave us both the impression of being trustworthy and the feeling that the customer is in focus.
How to select a CDMO for a biopharmaceutical project or programDownload
About the writer
Hans Arwidsson, CEO of Eurocine Vaccines.
Dr. Hans Arwidsson holds a M.Sc. and a Ph.D. in pharmaceutical sciences from Uppsala University as well as an Executive MBA from Stockholm School of Economics. After more than three decades of broad cross-functional executive experience from the pharmaceutical industry he is now CEO of Eurocine Vaccines – a vaccine development company.
About Eurocine Vaccines
Eurocine Vaccines is a development company in the highly intense vaccine area, bridging the gap between innovation and market. Through its portfolio strategy, innovative vaccine candidates are given the opportunity to reach the market quicker, while investors are offered risk diversification with a big future leverage. These candidates are later licensed to partners for commercialization. The company is in the possession of its own technology platform, Endocine™, which has been tested in four extensive clinical studies with over 400 subjects. Listed at Spotlight Stock Market, XSAT, Eurocine Vaccines, EUCI, today operates at the heart of the bio-scientific cluster of Karolinska Institutet, Solna, Sweden and has attracted several internationally merited vaccine specialists to its board.