ADC single-use clinical platform for Bayer

When the cooperation with Sartorius started, Bayer’s starting point was the production of an ADC for clinical studies at 10g/batch scale in process development.

To meet future demands and supply clinical studies, a scale-up strategy for ADCs manufacturing was initiated.

To meet future demands and supply clinical studies, a scale-up strategy for ADCs manufacturing was initiated. 

The objectives of the project were to produce clinical batches from 30g to 500g of ADC per batch and at 6/30/100L scale. In addition, one constraint was the handling of different ADCs in the same facility (multi-product areas), whilst avoiding cross-contamination risks. Simultaneously: minimizing toxic waste streams, not jeopardizing environmental & work safety and lowering substantially the capital investments.

Together, Bayer and Sartorius studied the feasibility to develop a process platform based on single-use technologies, including the conjugation step.

"Sartorius Stedim Biotech supported  us to process ADCs from clinical phase I to phase III, by delivering a fully integrated single-use ADC platform which could fit into an isolator" said Berthold Boedeker- Global Biologics - Biotech Development. "We were impressed by the flexibility provided by the FlexAct system, and with the project management all along the process of our cytotoxic products.”

For many types of cancer, classical chemotherapy is often the only form of treatment available. It works on the basis of a cytotoxic effect: a “toxin” kills cancer cells, with the result of halting tumor growth. However, since such drugs also damage healthy cells, patients suffer from severe side effects.

Modern cancer therapies now target the tumor cells more precisely. They include the recently developed process of antibody-drug conjugates (ADC). Bayer HealthCare currently has several projects using ADC’s in its R&D pipeline.

When the cooperation with Sartorius started, Bayer’s starting point was the production of an ADC for clinical studies at 10g/batch scale in process development.

Today Bayer uses to a large extent Sartorius single-use solutions, which includes contained and closed disposable assemblies; from conjugation to final drug substance dispensed into storage bags. An Isolator is used for critical steps for optimal operator and environmental safety.

With the combination of innovative flexible systems, closed single-use assemblies and the appropriate containment strategy, ADCs can be manufactured in a multi-product cGMP facility. The choice to go for single-use solutions also limits the CAPEX investment and enables higher reactivity regarding the adaptation of production capacities to market needs.

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