In this week’s news, US concerns about reliance on API imports, US FDA has no plans to audit foreign plants and more…
US lack of API contractors a national security threat says study
The US continues to lack sufficient domestic production capacity to meet API needs according to the authors of a new study.
The study by researchers at the University of Washington says pharmaceutical industry desire to reduce costs – “race to the bottom” – has let suppliers in lower cost regions out compete US producers.
The study cites the causes for US weakness in API manufacturing and the ‘race to the bottom’ on pricing against global players, reporting structural advantages for ex-US manufacturers in greater government subsidies, lower input costs, and lesser regulatory burdens.
The authors suggest the US needs to support local API CDMOs until the sector reaches a “critical mass of domestic manufacturing infrastructure to protect domestic interests.”
They also urge US drug companies to source locally to create “sustainable domestic markets for American manufacturers.”
US FDA: No plans to resume onsite inspections of overseas plants
No resumption of overseas facility inspections is planned in the short term according to the US FDA.
The US drug regulator has halted most facility inspections as a result of the pandemic, only sending auditors to sites deemed “mission critical.”
And there are no plans to carry out more GMP inspections plants anytime soon according to Alonza Cruse, the director of pharmaceutical quality operations in FDA’s Office of Regulatory Affairs.
He told attendees during a recent webinar that the agency will continue to rely on audits carried out by local regulators with which it has mutual recognition agreements.
Firms using continuous manufacturing must take steps against viral contamination, FDA
The US FDA has urged protein therapeutics makers using continuous manufacturing to take steps to keep products virus free.
The regulator made the suggestion in a recent concept paper along with more general advice on how industry can use 24/7 production to manufacture protein drugs more efficiently.
In batch mode drug making methods for removing these virus-like particles are well established. Viral safety processes for continuous-mode processes are less well defined according to the FDA.
“Continuous manufacturing is still a novel concept for therapeutic proteins, and there are few published studies dedicated to ensuring that such therapeutics are not contaminated due to viruses. Studies such as these provide both internal and external stakeholders with insights into understanding potential viral safety concerns and potential methods used for manufacturing developmental studies.”
The agency also said it is making effort to support additional research on the viral safety of continuous processes.
Also in the news
STAT reported ongoing US concerns about reliance on overseas API and drug suppliers. Politicians have deemed it a national security risk.
The FDA has launched a novel excipient review pilot programme. See press release.
Biopharma Dive looked at the recent FDA meeting about gene therapy safety risks and reported notes of cautious optimism.
The Financial Times covered the launch of a start-up firm that plans to use AI to design antiviral treatments.
The New York Times reported that the White House is seeking $65 billion for “Apollo,” its plan to prepare for future pandemics.
Some developments of note in the contracting sector:
Moderna has hired National Resilience to make doses of its COVID-19 vaccine at its Canadian manufacturing site.
Quotient Sciences will invest £6.3 million in its recently acquired facility in Alnwick, UK. The plan will expand drug substance manufacturing capability and will create 80 new jobs.