Training Seminar: Introduction to Analytical Method Development and Validation for Therapeutic Proteins Wednesday, January 21, 8:30 AM-4:25 PM - Thursday, January 22, 8:30 AM-12:30 PM Part of PepTalk: The Protein Science Week
This course is a panoramic review of analytical method development and validation for therapeutic proteins, including antibodies and enzymes. It is intended for scientists working on therapeutic proteins in AD, QC, PD or related functional areas. It starts with basic knowledge of work on therapeutic proteins: manufacturing of proteins drugs, regulatory affair knowledge and protein chemistry. It then discusses fundamentals and practical aspects of commonly used analytical methods for proteins, including methods for structure elucidation, glycan characterization, biophysical characterization, potency measurement, purity and impurity analyses. The course concludes with the strategy and common practice in method validation and method transfer, including regulatory compliance at different stages of product development, application of DOE and QbD. The course emphasizes practical applications, real-world examples and useful tips.
For full details visit www.chi-peptalk.com/peptalk_content.aspx?id=140090&libID=140061
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Analytical Method Development & Analytical Method Development & Validation for Therapeutic ProteinsValidation for Therapeutic Proteins
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Jichao (Jay) Kang, Ph.D., RAC
Director, Analytical and Formulation Development
Gallus Biopharmaceuticals NJ, LLC
Course ObjectivesCourse Objectives
Basic scientific and industrial knowledge of working on proteins (including antibodies)
Get familiar with commonly used analytical methods: purpose, advantages, limits, pitfalls
Get familiar with Protein CharacterizationGet familiar with method validation and method
transfer: principle, common practice, and potential problems
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Basic Structure of MAbBasic Structure of MAb
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Major N-linked GlycansMajor N-linked Glycans
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Classified depending on the extent of processing:High mannose: lack Gal or GlcNAc at the end of antennaeComplex: GlcNAc after the Man at the antennaeHybrid: have both Man and Gal/GlcNac at end of the antennae
Hybrid and Complex types can have two or more branches, termed Bi-antennary, tri-antennary, or Tetra-antennary
Reduced CE-SDS of MAbReduced CE-SDS of MAb
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SEC-HPLC-MALSSEC-HPLC-MALS
Three detector monitoring
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Hydroxylated Proline and Lysine by AAAHydroxylated Proline and Lysine by AAA
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Protein Structure Elucidation by MS/MSProtein Structure Elucidation by MS/MS