Forced Degradation Studies

This workstream looks at approaches for collecting more robust data in forced degradation studies to increase product stability and allow for comparison studies.

Complex strategies, contradictions and delayed submissions

Strategies associated with understanding biologics degradation are complex. Building a case to support Biologics Licensing Application (BLA) to health authorities can be varied. Contradictions between critical quality attributes and forced degradation product analysis increases the workload. Submissions can be delayed when trying to meet regulatory expectations.

Development of best practice and regulatory requirements alignment

This workstream explores varied approaches to forced degradation studies. Members learn from each other how relevant different approaches have been in relation to long-term degradation. The workstream is defining a clear and consistent best practice approach to forced degradation studies based on industry experience and understanding.

Forced Degradation Studies deliverables

DeliverableDateDetailsDownload

An industry perspective on the use of forced degradation studies to assess comparability of biopharmaceuticals

17 January, 2024Link

An industry perspective on common practice in forced degradation studies of biopharmaceuticals

1 August, 2023Webinar

An intercompany perspective on compatibility and in-use stability studies to enable administration of biopharmaceutical drug products

31 July, 2023Webinar

An intercompany perspective on practical experiences of predicting, optimizing, and analyzing high concentration biologic therapeutic formulations

27 July, 2023Webinar

Use of forced degradation for formal comparability assessments survey

19 May, 2022Member only

Forced degradation studies for drug product (DP) (lyo change to liquid for late phase) to support comparability

25 October, 2021Member only

Forced degradation study correlation to long term stability

25 October, 2021Member only

Forced degradation studies oxidation studies

25 October, 2021Member only

Slide Deck – Forced degradation studies (FDS): An industry perspective on common practice in forced degradation studies of biopharmaceuticals

23 June, 2021
3.68 MB
95 downloads

Forced degradation studies (FDS): An industry perspective on forced degradation studies of biopharmaceuticals: survey, outcome and recommendations

31 January, 2020Link

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