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Tag: CMC Bioanalytical

The Importance Of GMP Certification In Drug Development

Production and sale of therapeutic drugs requires tight control over the manufacturing, processing, and labeling of these products to ensure the safety of the end…

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ADCC and CDC Assay: Validation and Optimization

Antibody dependent cellular cytotoxicity (ADCC) is a mechanism in host immune defense where antibodies bind to an antigen on the surface of a cell, targeting…

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CMC Requirements for Cell and Gene Therapy for IND Applications

The U.S. Food and Drug Administration (FDA) has issued Chemistry, Manufacturing, and Control (CMC) recommendations for Investigational New Drug (IND) applications for human investigational gene…

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The Benefits of Hiring the Right CRO

Short for Contract Research Organization, a CRO is a company that provides clinical research support to the pharmaceutical, biotech and medical industries on a contract…

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Bioanalytical Testing Under GMP: Assuring Biologic Safety & Efficacy via Impurities Assays

We discuss the need to put phase-appropriate methods in place to identify and quantify both process- and host-cell related impurities throughout the drug development process.

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Bioanalytical Testing Under GMP: Optimizing Cell-Based Potency Assays

Cell-based bioassays are expected by health agencies as one of the release specification methods for potency assessments in the drug development process. We take a…

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