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Scientific discovery and innovation have resulted in the successful introduction of various biological therapeutic modalities. However, drug product developers continually face new challenges that require changes to routine guidelines and manufacturing practices. While the drug product development process is well established for protein and peptide therapeutics, gene or cell therapy approaches face a greater level of stability challenges and unconventional GMP processes.

This presentation discusses how formulation development can be customized not only for conventional molecules like antibodies, but also for new biological modalities to address fundamental regulatory guidance. Examples of modality-dependent critical quality attributes and how those can be used to systemically build a good quality product are also covered.

  • A 30-year personal journey through biologic drug development:
  • Proteins to antibodies to gene therapy and vaccines
    Recurring themes, issues, and solutions
    The commercial importance of getting the formulation right

  • Phase appropriate priorities and development process
  • Key guiding principles


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Dr. Byeong Chang

Founder and Chief Scientific Officer

Integrity Bio

Dr. Chang is the Founder and Chief Scientific Officer of Integrity Bio, a 17-year-old company, based in Thousand Oaks, California, focused on formulation and cGMP fill/finish of injectable biologics. He recently founded the Vaccine Stabilization Institute, a company focused on formulating stabile viruses and viral vectors for vaccine and gene therapy applications.

Dr. Chang has over 30 years of experience in biopharmaceutical drug product development for companies including Amgen, Synergen, Cetus and SK&B. While at Integrity Bio, Dr. Chang has worked with hundreds of companies ranging from Global Fortune 500 companies to virtual biotechs. He has worked on a wide variety of therapeutic modalities totaling well over five hundred products. He holds a Ph.D. from the University of Massachusetts.

Hosted by

Maire Gerrard

Custom Content Writer

Informa Pharma Intelligence

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