The BioPhorum and USP collaborative journey to new standards
BioPhorum and United States Pharmacopeia (USP) share a common direction – to accelerate biopharma innovation, quality and progress through collaboration.
To this end, USP is engaging with industry to understand its pain points, its challenges and where there is the potential for new standards.
“We 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,” said Diane McCarthy, Senior Manager, Science & Standards-Global Biologics at USP. “These would go across a particular product class or even multiple product classes. We are tentatively calling these ‘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 BioPhorum Development Group (BPDG) has surveyed its members to identify problematic and prolific HCPs and their use. USP will use this survey feedback, and follow-up discussions with the BPDG, to inform its plans to create HCP standards for mass spectrometry.
“In the long term, it would be very useful that there are uniform standards for companies such as Bristol Myers Squibb,” said Satish Sharma, Senior Scientist, Process Development Analytics at BMS. “The harmonization of mass spectrometry standards and methods for HCP characterization is currently an unmet need.”
Industry is concerned that regulatory approval for novel excipients in drug formulations is onerous and places too much risk on manufacturers. This limits the options for formulating effective drugs, especially innovative therapies that need unique properties. The risk is that new excipients may not be discovered because of regulatory barriers.
The USP survey will help identify specific issues with using novel excipients in drug development and innovation. It will give companies the chance to influence future guidance that may remove some of the barriers to bringing improved novel excipients to the market.
The BPDG Formulation team members were given the opportunity to contribute to the USP survey on the state of innovation in excipients, and the current and future challenges of fulfilling public health needs. The survey will help USP in its approaches to standard setting and advocacy for more practical approval routes. USP will share the results of the survey with the BPDG Formulation team, which will give member companies early access to the analysis.
The conclusions of the HCP and novel excipient surveys will be widely shared beginning in May. They are examples of true collaboration: BioPhorum, the company members and the USP in working together to address existing and future quality challenges and promote further innovation in biopharma.
“It has been a pleasure working with both the BioPhorum Development Group’s member companies and the USP to collaborate on these topics,” said Tony Gill, the Group’s Phorum Lead, “and I look forward to exploring future opportunities that will benefit the industry”.