Bioassay


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Electronic data exchange – the foundation for an efficient, resilient inbound supply chain

The COVID-19 pandemic, geopolitical unrest, and military action across the world have fundamentally disrupted the assumption and practice of a globally interconnected supply chain, cutting off cities and international supply hubs, and straining raw material supplies and stocks. These global events continue to put pressure on an inbound supply chain model that has its roots in ‘just-in-time’ lean manufacturing practices. A range of measures will...

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Everything you need to know about ‘ready to use’ cells … on a poster

Biologics potency is an important component of an overall CMC analytical control strategy, which is widely determined by cell-based bioassays. However, developing robust and reliable bioassays places increased requirements on the analytical cells with low inter-assay variability (e.g., cell passage number, harvest) to deliver high-quality potency data. ‘Ready to use’ cells (RtU) offer many benefits, including reduced assay variability, and...

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Bioassay development: Best practices in bioassay development to support registration of biopharmaceuticals: Presentation

This is a companion presentation to the paper Best practices in bioassay development to support registration of biopharmaceuticals has been written by members of BioPhorum Development Group Bioassay workstream and published online in BioTechniques in September 2019.

Available on to members of the phorum only was presented at USP’s 8th Bioassay workshop and at the PEGS Summit program at BioProcess International. Boston MA, Sept 2020.

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Bioassay development: Best practices in bioassay development to support registration of biopharmaceuticals

Biological activity is a critical quality attribute for biopharmaceuticals, which is accurately measured using an appropriate relative potency bioassay. Developing a bioassay is a complex, rigorous undertaking that needs to address several challenges including modelling all of the mechanisms of action associated with the biotherapeutic. Bioassay development is also an exciting and fast evolving field, not only from a scientific, medical and technological point of view, but also in terms of statistical approaches and regulatory expectations.
This paper discusses how bioassays are developed, challenges current thinking and discusses the benefits of different practices, and details a very practical industry-wide approach to the best practices for developing, implementing and maintaining cell-based assays.

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