Sterile Products Community (SPC) is excited to host an open scientific discussion on the topic of "Developing Patient-Centric High Concentration Biologics: Learnings from the Commercial Landscape". Dr. Hiten Gutka, Senior Principal Scientist at Bristol Myers Squibb and the current chair of SPC, will present trends in formulation composition and QTPPs of US FDA-approved and marketed high concentration antibody products (HCAPs) that are ≥100 mg/mL. Further, publicly-known novel formulation and processing technologies that enable the development of improved HCAPs at ≥200 mg/mL will also be discussed. The observed trends can be used as a guide for further advancements in the development of HCAPs as more complex antibody-based modalities enter biologics product development.
When: September 13th, 2024 at 12.00 noon EST
Where: Microsoft Teams meeting
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Meeting ID: 249 862 249 474
Passcode: SQwSyS