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CordenPharma was awarded the contract to supply critical lipid excipients for Moderna’s COVID vaccine formulation. What were the factors that enabled CordenPharma to move in such a fast manner to bring this product to marker?
When we were approached by Moderna we immediately understood the complexity. We put a global team together, relying on various competencies, and we used our global facility network to scale up rapidly. Initially work started in Switzerland and soon after, we involved other sites as part of our network. This has been the key to success.
How does establishing a relationship in one area with a biotech company lead to a deeper relationship over time?
When we engage as a CDMO with innovative biotech and pharma companies, it might start as a small project. As the project grows, we introduce more solutions such as technologies and different services. In general, we have a broad service offering in excipients, API and Drug Product manufacturing which allows companies multiple opportunities in working with us, depending on the needs of their project. This goes along with the trend that as companies simplify their supply chain, they look for partners who can offer end-to-end or integrated services. They look for partners who have a good skill set, and experience with broad capabilities. Having partners who can support you from early stages – grams to kilogram quantities, all the way to metric ton scale – that’s what these companies are seeking.
“Having partners who can support you from early stages – grams to kilogram quantities, all the way to metric ton scale – that’s what these companies are seeking.”
I initially thought COVID-19 was going to have a huge impact. We thought funding might go down and clinical projects would be delayed. However, a lot of funding was available, and a lot of other areas are growing. We have seen many non-pandemic-related opportunities come our way. The only negative aspect is that some clinical trials have been delayed due to COVID-19. Particularly in the US, a lot of innovation is happening, and we see very strong demand for our services, even beyond our pandemic related business. The platform technologies that have grown the fastest are Highly Potent and Oncology, Peptide, Lipids & Carbohydrates, and Injectables.
We implemented some of this already in our CordenPharma Chenôve facility near Dijon, France. The advantage of continuous manufacturing is that you can run chemistry which might otherwise require much larger capital investment and infrastructure. Continuous manufacturing can give real benefit when manufacturing certain complicated APIs with complex steps. It is also more environmentally friendly by reducing the amount of solvents used, or employing certain reagents you otherwise could not use. It does, however, require a deep analysis. You should only use it where it makes sense, but we see a big potential in this technology on the API side.
We are also discussing continuous manufacturing for Drug Product tablets. It is more complicated because it requires a customer who is willing to champion such a continuous manufacturing process. It is a bit more easily applied to intermediate non-regulated starting materials once you get the API, but Drug Product continuous manufacturing is even more complex, especially in regards to the regulatory filing.
Standard antibiotics are coming out of India and China, so the essence of discussion is, should this capability be brought back to Europe? Yes, but in the end, somebody has to pay for it. The cost of manufacturing in Europe or the US is going to be significantly more expensive, so if customers are not willing to increase the price later, and also not willing to pay more in advance, it will be a difficult discussion. We are, therefore, unsure how things will play out. On the other hand, we have customers who say, when it comes to starting materials, they prefer a Western source instead of an Asian one. CordenPharma accommodates these requests because of our inter-network relationship with our sister company WeylChem, which is focused on making raw materials and complex starting materials for GMP manufacturing. This partnership is very successful, and we are seeing an increasing interest from new and existing customers towards back-integration from a Western source for these materials.