Rapid detection of bacteria and viruses: justification, regulation, requirements and technologies - how can industry achieve broad adoption?

One of the main targets for BioPhorum Technology Roadmapping is to reduce the testing times for bacteria (including mycoplasma), fungi and viruses in biological therapeutics from four weeks to just one or two days. It has made significant progress on understanding the challenges to achieving this goal, which are captured in the publication of the white paper Rapid detection of bacteria and viruses in bioprocess samples: justification, regulation, requirements and technologies - how can industry achieve broad adoption

The paper addresses the main factors preventing the use of alternative rapid microbiology methods (RMM) for testing to assure sterility and the absence of adventitious agents in the manufacturing process. Ultimately, it aims to move the industry towards the real-time release of drug products.

The project evolved out of the first edition of BioPhorum’s BioManufacturing Technology Roadmap. “One of the biggest desires from biomanufacturers was to shorten the testing time for release,” explained Audrey Chang, Head of Process Solution Services R&D at Merck. “Our group came together to ask, ‘What can we do to move towards that vision?’

“We recognized that implementing these newer technologies in a regulated environment is challenging, [in particular] demonstrating how they are at least equal to, if not better than, current methods. And so, we thought that if we could share this burden of validation as an industry, we could all benefit.”

 Challenges

Realizing that the scope of the initiative was huge, the workstream (comprising nine biomanufacturers, three supply partners and an innovation hub), quickly established a need to split the project into phases.

Phase 1 was the white paper, aimed at identifying the barriers, listening to end-users and finding ways to resolve those barriers. To achieve these goals, the team conducted a survey, which found that the overwhelming barrier cited was one of regulatory acceptance.

“We’ve got a whole new dawn of medical treatments,” said Morven McAlister, Senior Director, Regulatory & Validation Consultancy at Pall Biotech, “and these new technologies will need these rapid methods. There’s no way we can fully realize their potential if we don’t implement them. We’d like to be able to tie these to existing products as well.”

The survey also revealed the need for what McAlister calls “a playbook”—a guidance document that gives end-users “a tool that will help them understand what they need to do to qualify and validate these alternative rapid micro methods.”

Also, the costs and time associated with manufacturing and filing post-approval changes were raised as concerns. However, one key factor should also not be overlooked, added McAlister. “This wonderful collaboration is all going towards safety in trying to get drugs to the patient faster. It’s not just a case of reducing manufacturing costs, it is ultimately about patient safety.”

Three milestones

A key moment for the workstream came in October 2018 when, as part of a wider BioPhorum microbial control group, it met with the FDA.

Chang explained that today, companies approach the regulators individually with their method validation studies. In this manner, regulators view similar studies in a siloed approach. A more preferable approach would be a shared method validation, where comments and best practices would benefit both industry and regulators.

The discussions were extremely fruitful. “The take-home message for us was that [the FDA] were not only open to our group and what we were trying to do, they encouraged it,” said Chang.

According to Chang, this shows the power of BioPhorum and the feedback from the FDA was that “they really liked the fact that we went not as individual companies but as part of BioPhorum and we represented a consensus viewpoint.”

The project’s second key achievement was the survey, which showed that the interest and drive to implement RMM was widespread. “It really validated our premise that the low level of adoption was not related to a particular method or particular instrument” said Chang. “People recognized that they wanted to implement this and the roadblock was really more of a need for a procedure as to how do we move forward.”

According to Scott Hooper, Associate Director Microbiology at Merck Inc Kenilworth, NJ, the third triumph will be realized once the white paper is published as it will “give people a framework to deal with the barriers, not all of which are technical. There are a lot of different things that we have touched upon in the paper and I think it will provide the tools to move those forward.”

Next steps

“The next stage is to really understand what we have to do to come up with the playbook,” said McAlister. “This will also have regulatory input, which is important. Many others have come up with papers on how to qualify and validate such methods, but this one—because of the collaboration involved between end-users, suppliers, labs and regulators—will be a really powerful document for the industry.”

Phase 2 will see the team develop user requirement specifications to help guide vendors for technology development in this area.

“This paper defines the problem, but there’s a lot of things we want to do in terms of developing solutions and then, of course, implementation,” added Chang, who sees the initiative being a multi-year project—but one that will beat the 10-year timescale set out in the BioPhorum Roadmap.

For more information, contact the Phorum Facilitator Bela Green on bela@biophorum.com

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