Sterile Products Community

Dear all, a friendly reminder to join our upcoming scientific discussion in SPC community next Friday focusing on "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. 

Hello Haresh

Nice topic but could you provide more detail on the specific date / time / call in etc. 

Satish

------------------------------
Satish Singh Ph.D., FAAPS
Vice President, Drug Product Development
Astria Therapeutics
Boston MA
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.

Original Message:
Sent: 09-06-2024 12:13
From: Haresh More
Subject: Developing Patient-Centric High Concentration Biologics

Dear all, a friendly reminder to join our upcoming scientific discussion in SPC community next Friday focusing on "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.