In this week’s news, Trump administration fails to reach vaccine production goals, The Office of Pharmaceutical Quality (OPQ) is working on a rating system for drug and API suppliers’ quality management systems and more M&A activity.
Trump’s “Warp speed” falls short of vaccine goals
The Trump administration’s “Operation Warp speed” programme failed to achieve its own vaccine production goals according to a report by the GAO.
The US Government Accountability Office (GAO) published its assessment last week, explaining that the aim of producing 300 million COVID-19 vaccine doses by January 2021 was not met.
The GAO wrote that, “OWS officials reported that 63.7 million doses of vaccines were released to the federal government as of January 31, 2020” explaining that manufacturing issues prevented the project achieving its production goals.
Since the inauguration of President Joe Biden, the situation has improved. The GAO said firms have been working to increase capacity and seeking advice on CDMOs from OWS officials.
“For example, one vaccine company told GAO that HHS’s Biomedical Advanced Research and Development Authority helped them identify an additional manufacturing partner to increase production,” the GAO wrote.
OPQ helping US FDA develop rating system for drug and API suppliers
The Office of Pharmaceutical Quality (OPQ) is working on a rating system for drug and API suppliers’ quality management systems.
The OPQ shared details in a report this week, explaining the project was prompted by disruption caused by the pandemic.
“Although COVID–19 travel restrictions postponed non-mission-critical facility inspections, OPQ staff made use of alternative tools for manufacturing facility assessments, avoiding the need to conduct 153 on-site facility inspections prior to approving applications.”
One approach is the development of a framework for appraising quality management practices in collaboration with Dun & Bradstreet and the University of St. Gallen in Switzerland. The project – which involved over 200 pharmaceutical manufacturing establishments – some of which were inspected by a contractor.
The OPQ has established “quality management maturity” a pilot programme and invited domestic finished dosage form manufacturers and overseas API suppliers to to help the FDA develop a rating system. The pilot will run until the end of the year.
Also in the news
Contract Pharma covered TCG Lifesciences’ launch of a CDMO. The new unit will be called TCG GreenChem and provide CMC services and API development and production services.
The Korea Times spoke with Pae Ji-soo, Genome & Company CEO, about the role the microbiome will play in personalized medicine.
Some developments of note in the contracting sector:
Specialist services firms CytoImmune Therapeutics and Biosimilar Sciences have announced plans to set up operations in Puerto Rico. Read more at Bioprocess Insider.
Evonik will invest in lipid production capacity at its Hanau and Dossenheim sites in Germany in partnership with vaccine manufacturer BioNTech. The aim is to increasing the supply security for the Pfizer-BioNTech COVID-19 vaccine. See full Contract Pharma story.
The EC has cleared the acquisition of joint control of Recipharm by EQT Fund Management, Zentricity and Cajelo Invest. See more at the Pharma Letter.
Providence Therapeutics has hired Emergent BioSolutions to provide fill-finish services for its candidate mRNA vaccine for SARS-CoV-2, the viruses that causes Covid-19. See press release.