An industry perspective on common practice in Forced Degradation Studies of biopharmaceuticals

Broadcast date

Tue, Jun 15, 2021

 

Presented by

    Surinder Singh - BMS
    Niclas Chiang Tan - Takeda
    Göran Hübner - Boehringer Ingelheim
    Christoph Grapentin - Lonza Drug Product Services
    John Campbell - GlaxoSmithKline R&D
    Liqiang Lisa Zhou - AbbVie
    Elaine S.E Stokes - BioPhorum

 

Quick Description

Forced degradation studies (FDS) are a crucial part of the drug lifecycle process because companies need to fully understand their molecule, including how it reacts to different stress conditions.

Details

Forced degradation studies (FDS) are a crucial part of the drug lifecycle process because companies need to fully understand their molecule, including how it reacts to different stress conditions.

However, there is a lack of clear regulatory guidance on how, when, and why to undertake FDS—only that they should be performed to understand a product further. This means many companies commit a huge amount of time and money to these studies and use trial and error to develop a standardized approach.

To gain an understanding of current industry approaches to FDS, the BioPhorum Forced Degradation Point Share conducted an inter-company collaboration exercise, which included a benchmarking survey and group discussions around forced degradation studies of monoclonal antibodies.

The results of this industry collaboration provide insights into the practicalities of these characterization studies and how they are being used to support the product lifecycle from innovation to marketed products. In this webinar, SME’s will take you through this global benchmarking survey from across 12 companies and present these as a guide to a common approach to FDS across the industry which can be used to guide the design of FDS based on CMC product life-cycle and biomolecule needs.

Speakers

Surinder Singh

Senior Scientist

BMS

Niclas Chiang Tan

Director

Takeda

Göran Hübner

Head of Laboratory

Boehringer Ingelheim

Christoph Grapentin

Principal Scientist

Lonza Drug Product Services

John Campbell

Scientific Leader and GSK Fellow

GlaxoSmithKline R&D

Liqiang Lisa Zhou

Principal Research Scientist

AbbVie

Elaine S.E Stokes

Account manager and Facilitator

BioPhorum