In this week’s news, the Whitehouse announced plans to make US API supply chains more robust, US FDA tweaks EUA for Pfizer’s COVID-19 vaccine and more…
US moves to make API and drug supply chains more robust
US President Joe Biden has said he wants to make the country’s API and drug supply chains “resilient, diverse, and secure,” citing economic and national security.
The plan was outlined in an executive order issued by the Whitehouse this week.
The order tasks the Secretary of Health and Human Services with compiling a report “identifying risks in the supply chain for pharmaceuticals and active pharmaceutical ingredients and policy recommendations to address these risks.”
Like orders issued by the previous administration, the new document identifies increasing domestic production as a key goal.
It states, “More resilient supply chains are secure and diverse — facilitating greater domestic production, a range of supply, built-in redundancies, adequate stockpiles, safe and secure digital networks, and a world-class American manufacturing base and workforce. “
The Association for Accessible Medicines welcomed the order.
The latter organisation told Drug Store News it is a “prudent, considered approach to fully understanding the scope and capacity of current US pharmaceutical manufacturing.”
US Oks shipment of Pfizer COVID-19 vaccine at higher temp
The US FDA said it will let Pfizer and Biontech’s SARS-CoV-2 transport their COVID-19 vaccine at temperatures found in conventional pharmaceutical freezers.
Last week Pfizer and BioNTech submitted data showing the vaccine is stable at higher temperatures based on manufacturing data.
EDQM to implement revised sartan monographs by April
The European Directorate for the Quality of Medicines (EDQM) will implement new sartan monographs that were adopted through its new “rapid revision procedure” on 1 April.
The monographs make clear how producers must assess the risk N-nitrosamine – a carcinogenic contaminant found in some drugs containing the API – will be formed during manufacturing.
The also specify how, if a risk is identified, manufacturers should go about changing processes to minimise potential contamination.
Also in the news
Kaiser Health Network looked at problems in COVID-19 vaccine supply chains in the US.
Outsourcedpharma examined the threats and opportunities currently defining the CDMO space.
Bioprocess Insider spoke to the new CDMO setting up shop in GSKs site in Ulverston in the UK.
Bloomberg wrote about Biontech’s efforts to expand vaccine manufacturing capacity. The firm is retrofitting an ex Novartis plant to supply 750 million doses a year of mRNA vaccine.
B-MS has started work on a new cell therapy manufacturing facility in Devens, Massachusetts. See press release.
CPhI Online looked at biopharma’s adoption of digital manufacturing technologies.
Softbox, a passive temperature controlled packaging solutions provider has hired ex Pfizer technical solution specialist Matthew Tomkinson. Read more a Packaging News.
Some developments of note in the contracting sector:
Avid Bioservices has started the second phase of expansion of its facility in Myford, California. The CMDO expects the project to take around 24 months and cost $45 million to $55 million.
Catalent plans to buy Belgian CDMO Delphi Genetics to add capacity in a plasmid DNA (pDNA) production and cell and gene therapy manufacture.
Pfizer has added AMRI to its list of excipient suppliers for its COVID-19 vaccine.