Biopharmaceutical formulations often present as complex mixtures that can be sensitive to heat, light, and many other factors, all of which must be monitored and assessed. However, until recently, developers worked mostly independently, with only their own resources and expertize to develop those assessments and set acceptable parameters.
Within BioPhorum, competing companies can work together and benefit from sharing information that accelerates progress for everyone and ultimately can lead to publications to share those experiences with the wider biopharmaceutical industry. One such area is described in Closed-System Transfer Devices: Collaboration Provides Tools to Guide Compatibility and Stability Testing Strategy, which shares 18 months of collaboration amongst industry experts from the BioPhorum Development Group’s Formulation Workstream. The increasingly diverse range of closed-system transfer devices, components, materials, etc., make comprehensive testing impractical. Until now, each company has worked independently to develop assessment protocols and mitigate risks.
Dr Elaine Stokes, from BioPhorum, recently published in BioProcess International, shares how the formulation workstream subteam experts were able to identify commonalities in approach and opportunities to share non-competitive aspects of CTSD compatibility. The article describes an overview of the team’s recent peer-reviewed paper and highlights opportunities to learn from issues that other companies have overcome and to apply this learning in creating a risk-based approach for strategy development on CTSDs. For the industry, this approach allows companies to improve their efficiency, applying industry experience to the particular needs of their own company’s clinical program.
These efforts ultimately will help to ensure that patients receive safe and efficacious biologics and that healthcare workers are protected, providing the best possible public health outcomes for all.