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White Papers / Tech Papers

QbD Unlocked: Smarter Tech Transfer for Biologics 

A Data-Driven Approach to Process Characterization and Validation for Scalable, High-Quality Biologics Manufacturing

Released By Samsung Biologics

This white paper examines how Samsung Biologics and the industry at large apply a quality by design (QbD) approach to technology transfer (tech transfer) and process characterization (PC) for biologic drugs. Key concepts relating to QbD and the regulatory context will be discussed, covering the role of tech transfer and process validation (PV) in a drug’s lifecycle, the principles of QbD and how PC fits in, and the use of design of experiments (DoE) in characterization, and a case study will be presented to illustrate these concepts for a monoclonal antibody (mAb) process.

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