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
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
To find out more about how BioPhorum can help your business, enter your details below and a member of our team will be in touch.