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Advisory Committee for Pharmaceutical Science

Advisory Committee for Pharmaceutical Science

Advisory Committee for Pharmaceutical Science. Process Analytical Technology and Biotechnology Products Keith O. Webber, Ph.D. Office of Biotechnology Products OPS/CDER April 13, 2004. Which Products?. Biological Products include:. Blood and Blood Products Vaccines Allergenic Products

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Inclusion List Builder Plug-In

Inclusion List Builder Plug-In

Inclusion List Builder Plug-In. Inclusion List Builder. Goal: Create an easy to use lab tool for iterative construction of inclusion lists from MS level 1 and level 2 data to replace existing approaches that involve excessive manual intervention. (Iterative) Workflow. SpecArray/Superhirn

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A Highly Sensitive Method for Protein Product

A Highly Sensitive Method for Protein Product

Peptide mapping is the main method for the analysis and identification of protein products and preparations. In addition, there are some other core techniques such as peptide mass mapping and peptide mapping ms.

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peptide mapping

peptide mapping

Peptide mapping, the principal technique for confirming a proteinu2019s primary structure (amino acid sequence), can be used in drug discovery and throughout the manufacturing process. It is one of the most important techniques in comparability studies of biologics and a key step in the characterization of biopharmaceutical proteins. For recombinant protein drugs, such as monoclonal antibodies (mAbs) and antibody drug conjugates (ADCs), peptide mapping can be used for identification, primary structural characterization, and quality assurance/quality control (QA/QC). Some global regulators, like the US Food and Drug Administration (US FDA) and the European Medicines Agency (EMA), have developed guidelines to ask for providing peptide mapping to confirm the amino acid sequence of drug substance proteins.

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Biosimilar Testing Services

Biosimilar Testing Services

A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product. Biosimilars are officially approved versions of original "innovator" products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. Unlike with generic drugs of the more common small-molecule type, biosimilars generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. That is why you need accurate analysis at every stage.

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32 views • 2 slides

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