Tag: <span>ind</span>

Antibody-Dependent Cellular Phagocytosis: The Mechanism of Action That Gets No Respect A Discussion About Improving Bioassay Reproducibility

Antibody-dependent cellular phagocytosis (ADCP), which relies on macrophages to attack and devour tumor cells following antibody binding, is a potentially useful mechanism of action (MOA) for antibody drug developers and vaccine makers to consider in determining product efficacy. Unfortunately, it is often ignored in favor of more accessible MOAs driving biological function such as antibody-dependent cellular cytotoxicity (ADCC) because the assays are tedious to prepare, perform, and reproduce.

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Biologics Biologics Production Regulatory

adcc antibody-dependent cellular cytotoxicity bioassays ind investigational new drug mab mechanism of action moa monoclonal antibody ph eur USP

Regulatory and Monetary Drivers for Real-Time Analytics

Implementation of ā€œreal-timeā€ analytics (RTA) in processes for biologics is challenging from a technological and timeline perspective. Therefore, there need to be significant drivers from both a regulatory (quality) and a monetary standpoint to justify investment. Understanding how regulatory agencies define real-time analytics and the expectations for implementations (how and when) is a key component to rational decision-making, and dovetailing process improvement and facility design is important in the planning and development processā€¦

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Biologics Production Cell & Gene Therapy Cell Lines Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

at-line analytics biolgics design space biologics cpp critical process parameters design-of-experiments doe fda guidance fmea in-line analytics ind investigational new drug mabs monoclonal antibodies on-line analytics pat process analytical technology real-time analytics regulatory considerations rta