UPDATE | October 14, 2024

Formulation considerations for the development of high concentration biopharmaceuticals

  • MAIL

This webinar discusses the challenges of developing high-concentration biopharmaceutical formulations, such as increased aggregation, viscosity, and opalescence. It also presents case studies on how to manage these issues and practical strategies for streamlining the formulation process, with a focus on enabling subcutaneous administration for patient convenience.


Key learning objectives:

  • Understand challenges in developing high-concentration biopharmaceutical formulations.
  • Discuss fundamental formulation principles and tools for successful high-concentration formulations.
  • Explore Samsung Biologics’ practical strategies for developing high-concentration formulations.
    • Small-scale tangential flow filtration to understand pH shift
    • Small-scale spikes to understand feasibility of achieving spikes and provide final pH/osmolality of the final formulation
    • Evaluation of screening methods for high-concentration formulations — HIAC dilution and SEC dilution


This webinar discusses the challenges of developing high-concentration biopharmaceutical formulations, such as increased aggregation, viscosity, and opalescence. It also presents case studies on how to manage these issues and practical strategies for streamlining the formulation process, with a focus on enabling subcutaneous administration for patient convenience.


Key learning objectives:

  • Understand challenges in developing high-concentration biopharmaceutical formulations.
  • Discuss fundamental formulation principles and tools for successful high-concentration formulations.
  • Explore Samsung Biologics’ practical strategies for developing high-concentration formulations.
    • Small-scale tangential flow filtration to understand pH shift
    • Small-scale spikes to understand feasibility of achieving spikes and provide final pH/osmolality of the final formulation
    • Evaluation of screening methods for high-concentration formulations — HIAC dilution and SEC dilution


  • CDO
  • CGMP
  • ADC
  • Bio Campus
  • IR
  • CMO

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