We offer flexible solutions for the entire lifecycle of your product, from preclinical to commercial stages.
Depending on the needs of your molecule and your program, we can utilize our global network and capabilities to offer the appropriate suite of services. The variety of our offerings provides the flexibility of a complete program, from gene to drug product, or the option to drop in at a later stage depending where you are in your journey.
Preclinical to early clinical manufacture
Our preclinical to clinical drug substance manufacturing services offer scales of 1kL-20kL and non-GMP pilot scales from 50L to 500L. Our production sites are state-of-the-art and offer a global solution for your early clinical mammalian manufacturing needs.
Late clinical to commercial manufacture
Our mammalian late clinical to commercial manufacturing services offer scales of 1000L to 25000L. Our bioreactors include both single use technologies up to 2000L scale and stainless-steel reactors from 6000L to 25000L, providing you with the agility to react to changing product demand and readiness for the right commercial scale.
In determining which scale and location is most appropriate for your project, we discuss with you the clinical path, product needs and product launch and commercialization strategy. We consider both your mid and long-term needs.
We have a global network of seven production sites that offer comprehensive clinical and commercial mammalian manufacturing to meet your needs.
Our BLA approach is tailored to your needs
Benefit from access to our extensive experience with writing and supporting the preparation of your BLA/MAA in support of commercialization. We start several new BLA programs per year with an approach that balances different priorities, timelines and risks and provides an overview of the entire program.We can help you accelerate your product market readiness and reduce overall project time with our mammalian drug substance manufacturing services.