See how BioDlink’s digital-intelligence platform is driving three major improvements in lyophilization workflows.

Contract manufacturers have special expertise in the characterization and validation of biopharmaceutical manufacturing processes. Process development is a key factor in the development and ...

Microbial systems offer distinct advantages in protein expression, saving costs and time, and offering well-characterized host genetics and ease of scale-up. 2 However, challenges remain in process ...

Samsung BioLogics was established in 2011, since then, the company has firmly positioned itself as a leader within the biopharmaceutical manufacturing industry, producing high-quality products, ...

In this webcast, Catalent will share a case study of a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline. Process characterization and validation is an ...

The new unit has already started shipping to customers. WACKER is thereby optimizing the entire process-development chain, from gene to purified protein. The new unit can now ship double-digit gram ...

As biologics programs progress toward commercialization, late-stage development introduces distinct challenges—from scaling processes efficiently to ensuring regulatory readiness and maintaining cost ...

The “Guidelines on Similar Biologics” prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) was released in June 2012, describing how ...