The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is partnering with the industry consortium BioPhorum to develop a more streamlined, cost-effective, and resource-conserving way of addressing the buffers used in biopharmaceutical manufacturing.
As upstream manufacturing processes gain efficiencies, the traditional supply line for custom-made buffers used in down-stream processing has become a production bottleneck. In keeping with NIIMBL’s mission of advancing biomanufacturing innovation, the public/private partnership has joined with BioPhorum to develop a compact, on-site buffer production skid that can greatly reduce lag times, storage requirements, and costs.
Headquartered in the UK, BioPhorum is an international industry collaboration formed a decade ago to address pressing biopharmaceutical development/CMC issues. Currently the work is done through teams or “phorums” focused on nine key areas: ● cell and gene therapies ● development ● drug substance ● fill/finish ● regulatory ● information technology ● supply chains ● technology roadmapping, and ● medtech. NIIMBL has worked with BioPhorum’s roadmapping group on the development of biomanufacturing roadmaps in for gene therapies, ADC’s/bispecifics, and vaccines (see IPQ January 11, 2019).
Each of the phorums has its own mission statement. For example, the mission of BioPhorum Supply Partner is to transform the inbound supply chain “for the benefit of end users, supply partners, and patients alike” – resulting in a reduction in risk, nonvalue-adding waste, and lead times, and an increase in effectiveness, reliability, and quality compliance.
At the ISPE Facilities of the Future conference held in San Francisco at the end of January, NIIMBL Director Kelvin Lee included an overview of the buffer program partnership with BioPhorum in his update on the institute. He explained the challenges of the traditional buffer supply chain and the benefits of the new, integrated production process that the partnership is developing.