When it comes to outsourcing, there is often confusion about the type of partner that is most appropriate for a project. In our previous article, we discussed the difference between a CRO, CMO and CDMO. In this article, we would like to zoom in on the different type of CDMOs in the field of biopharmaceutical contracting.
Different types of CDMOs
The term CDMO is becoming fashionable. More and more CMOs are adding the D for development to highlight that they have more to offer than manufacturing biopharmaceuticals. However, there is a great variety in CDMOs in terms of capabilities and expertise. For example, many of the large CDMOs apply a business model focused at late-stage and commercial manufacturing.
As a result, larger CDMOs tend to offer process development services only to those companies who are willing to sign for late-stage manufacturing, which is where most of their profit is generated. On the other hand, there are CDMOs whose primary focus is on process development rather than manufacturing. They perform GMP manufacturing only for the processes they have developed and know better than anyone.
The most notable difference in CDMOs is that between what we call a ‘vendor CDMO’ and a ‘Center of Excellence (CoE) CDMO’.
Vendor CDMOs focus on operational excellence, meaning they’ve optimized one or more standardized processes and, as a result, are able to keep the prices for their services below market average. These companies must apply economies of scale to keep their costs and, subsequently, their prices low. This requires heavy spending on facilities and equipment to achieve efficiencies.
Projects that are an excellent fit for vendor CDMOs are those that fit their standard processes. Typically, these projects are strongly defined by nature, and commodity based. The production of a master cell bank is an example of such a project. In general, making a cell bank is very straightforward. Outsourcing such a program to a vendor CDMO is an outstanding way to cut expenses, without too much risk.
Vendor CDMOs are able to handle large volumes of such projects, because they have optimized every step of the process. Their staff is trained to repeat the same step over and over again very accurately. But what if your program doesn’t fit the platforms of these CDMOs?
Center of Excellence CDMO
When you have a unique project, requiring a company to provide knowledge to make it a success, a CoE type of CDMO would be a better fit for you. CoE CDMOs provide leadership in a certain focus area, share best practices, perform research, and provide support. Many CoE CDMOs offer consultancy services next to their process development and manufacturing capabilities.
The business model of a CoE is based on creating long-term partnerships with their customers, to whom they offer tailored services. Because this model requires hiring a highly educated and experienced staff, requires a higher level of customer intimacy, and attracts more high-risk projects, prices tend to be above the market average. In return, the customer can expect a higher level of quality, flexibility and customer service than a vendor CDMO could provide.
Product development for a new viral vector-based product typically requires a custom-developed manufacturing process. In particular, scaling up viral vector production for clinical manufacturing requires specific know-how that can only be gained from years of experience in the field. For this reason, partnering with a CoE CDMO that specializes in viral vectors is often the wisest choice to de-risk and accelerate such programs.
Batavia Biosciences is a Center of Excellence for viral vaccine and viral vector development with extensive experience in the field of infectious diseases and oncology. Interested to learn more about what we can do to help your product development moving forward?