White Paper looks to support the successful development, validation and control of bioassays for successful drug development.
The correct bioassay is integral to drug development, providing an accurate picture of potency, stability and biological activity. However, bioassays can be complex and expensive, both in terms of cost and time. What’s more, they can be variable – for example, cell-based bioassays can lack robustness simply owing to the use of living cells.
A new White Paper from The BioPhorum Development Group (BPDG) has sought to ameliorate some of the challenges, presenting common practices and recommendations in bioassay development as discussed by the 22 BPDG bioassay point share (BPDG-BPS) members.
“These companies represent a wide perspective of current bioassay development in the biopharmaceutical industry. Therefore, the idea of capturing a condensed and harmonized view on the common challenges and best practices in bioassay development covering both strategic and tactical aspects came to fruition,” commented the authors. “The aim of this paper was to align regulatory expectations with best industrial practices in bioassay design.”
The authors go on to note that they expect an “evolution in the potency bioassay field” over the next decade, with more complex biotherapeutics such as cell therapies being brought into the clinic. “We are at the beginning of the journey and each question stimulates a new question, which promises an exciting future and new directions to come,” they concluded.
Read the full White Paper at https://www.future-science.com/doi/10.2144/btn-2019-0031
Written ByFrancesca Lake
Updated 20 August, 2019
SourceWhite JR, Abodeely M, Ahmed S et al. Best practices in bioassay development to support registration of biopharmaceuticals. BioTechniques doi:10.2144/btn-2019-0031 (2019). https://www.future-science.com/doi/10.2144/btn-2019-0031