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Berkshire Sterile Debuts Low Loss GMP Fill Process

Innovative sterile filling method was designed to reduce drug product loss for low volume fills of less than 1.2 liters.

Berkshire Sterile Manufacturing (BSM), a fill finish contract development and manufacturing organization (CDMO), completed their first GMP fill using their new low loss fill process. The process is an innovative sterile filling method that was designed to reduce drug product loss for low volume fills of less than 1.2 liters. An unintended benefit of the new process includes low shear.   “This product was not manufacturable with the conventional fill finish process, so it was very exciting to ...

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