cGMP Mammalian Drug Substance Manufacturing

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Capacity and Flexibility to Meet Your Needs

Leverage a globally integrated, world-class cGMP manufacturing network with accessible locations across the United States and Europe. Our experience and diverse manufacturing strategy offerings coupled with continued investments to increase capacity make us the partner of choice for developers looking for flexibility to manage their pipelines as they see fit. 

To determine a manufacturing strategy that best suits your biologics portfolio, work with a CDMO that provides both a variety of cGMP manufacturing techniques in-house, and expert insight to advise you on the best path to patients.

Our Mammalian Drug Substance Manufacturing Capabilities

There are three major biologic manufacturing strategies, each with specific advantages: scale up, scale out, and continuous. Opt to partner with a manufacturer that provides all three and seamlessly pivot as demand evolves throughout different clinical phases, affording a dynamic, cost-effective plan for the lifecycle of your drug.

Our scale up strategy produces large volumes of biological medicines and is ideal for customers in late-stage clinical development or those already undertaking commercial manufacturing. Our large-scale, stainless-steel manufacturing facilities leverage multiple 20,000 L bioreactors with high efficiency, lower cost of goods and sustainable modular-design that enable process transfers with unprecedented speed for maximum agility.

For partners early in development, managing uncertain demand forecasts or requiring mid-scale manufacturing, our facilities are designed to provide options to rapidly increase volumes for commercialization at the 2,000 L scale. We offer scale out cGMP manufacturing, utilizing single-use bioreactor technology and a closed processing ballroom design concept. Scaling out is ideal for manufacturing clinical and commercial targeted therapeutics, where the patient population and product demand are lower. 

Continuous is an innovative manufacturing solution that leverages smaller, single-use facilities that adapt easily to forecast fluctuations while providing the cost efficiency of large-scale systems. It combines flexibility and the potential to deliver high volumes with improved production efficiencies, and usually requires less capital investment and lower consumable costs upfront.

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Equipment for cGMP Production of Drug Substance
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