BioPhorum and United States Pharmacopeia (USP) share a common direction – to accelerate biopharma innovation, quality and progress through collaboration.
To this end, USP engages with industry to understand its pain points, its challenges and where there is the potential for new standards. Diane McCarthy, Senior Manager, Science & Standards-Global Biologics at USP stated that they have been looking at what additional standards we can develop that aren’t necessarily the traditional USP product-specific standards, but that would be helpful to the biologics industry more globally. These would go across a particular product class or even multiple product classes and are tentatively being called ‘performance standards.
This is where BioPhorum is playing a major role. The organizations are working together on the following two biopharma areas in which there are currently no USP standards. Benchmarking surveys into these areas are being used to gain the industry consensus that is crucial to the successful development and use of new standards.
Host cell proteins
Proteins originating from the host cell during recombinant production can affect drug safety and efficacy if they are not reduced in downstream production. Recent USP roundtables have highlighted the need for standards and tools to identify and quantify host cell proteins (HCPs) using mass spectrometry USP has asked for help to refine the potential uses, formats and types of HCP standards for mass spectrometry, which will make it much easier for industry to detect and identify certain HCPs. These standards will improve efficiency, time and costs as companies will not need to develop their own standards.
To aid the development of new USP standards in this area, the Development Group surveyed its members to identify problematic and prolific HCPs and their use. USP is now using this survey feedback to inform its plans to create HCP standards for mass spectrometry.