1 / 12

Analytical Method Development & Validation for Therapeutic Proteins

Analytical Method Development & Validation for Therapeutic Proteins. Jichao (Jay) Kang, Ph.D., RAC Director, Analytical and Formulation Development Gallus Biopharmaceuticals NJ, LLC. Course Objectives. Basic scientific and industrial knowledge of working on proteins (including antibodies)

juan
Download Presentation

Analytical Method Development & Validation for Therapeutic Proteins

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Analytical Method Development & Validation for Therapeutic Proteins Jichao (Jay) Kang, Ph.D., RAC Director, Analytical and Formulation Development Gallus Biopharmaceuticals NJ, LLC

  2. Course 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 Characterization • Get familiar with method validation and method transfer: principle, common practice, and potential problems

  3. Basic Structure of MAb

  4. Major N-linked Glycans • Classified depending on the extent of processing: • High mannose: lack Gal or GlcNAc at the end of antennae • Complex: GlcNAc after the Man at the antennae • Hybrid: 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

  5. Reduced CE-SDS of MAb

  6. SEC-HPLC-MALS • Three detector monitoring

  7. HydroxylatedProline and Lysine by AAA

  8. Protein Structure Elucidation by MS/MS Roepstorff Nomenclature Scheme

  9. Secondary Structure by CD T Estey, J kang et al., Pharm Sci , 2006, 95: 1626–1639

  10. Timing for Method Qualification/Validation Qualification Validation Verification Method Development and Qualification Measurement defined Scientifically Defendable Ready for validation Fully Validated Method Transfer Methods related to product safety require qualification even at phase I Other methods need to be validated prior to BLA, but by phase III, you should have the methods that can be validated

  11. Case Study: Binding Assay Qualification Binding ELISA curves at different level

  12. Quiz # 15 • For an identification method, what are the validation parameters? • How to determine if a method is stability-indicating? • How to determine LOQ? • How to calculate method supported specification (SS)? • List three considerations in setting SST • List three method transfer pitfalls

More Related