In this week’s news… US FDA applauds industry anti-shortage efforts during pandemic, new ICH guidelines on analytics, CMC welcomed and more…

US FDA lauds CDMO and drug industry efforts in 2020 drug shortages report

Drug makers let the US FDA know about manufacturing disruptions and potential shortages sooner during the pandemic according to agency analysis.

The US FDA published its drug shortages report last week, revealing that political efforts to mitigate the negative impacts of the Covid-19 pandemic have had a positive impact on communications with the drug industry.

It wrote, “As FDA expected, the supply chain was impacted by the pandemic, leading to supply disruptions or shortages of drug products in the United States… As a result of presidential, congressional, and Agency actions, manufacturers are notifying FDA earlier than in the past about certain manufacturing interruptions and discontinuances that can lead to shortages.”

The agency also cited its own initiatives as important, explaining it asked manufacturers to evaluate their entire supply chain, including key starting materials, APIs, packaging components, and finished dosage forms.

The FDA said it “exercised regulatory flexibility and discretion in 110 instances, affecting 78 products,” adding that “Third-party oversight of production was instituted to monitor quality issues.”

Regulators and industry looking forward to new ICH analytical guidelines

Regulators and industry officials say soon-to-be-published guidelines will make selecting the best analytical methods easier for drug firms and CDMOs.

Executives at the CMC Strategy Forum sponsored by the California Separation Science Society (CASSS) this week said the guidelines – developed by the International Council on Harmonization (ICH) – will help manufacturers ensure products are of appropriate quality.

Also in the news

The New York Times looked at developments at Emergent Biosolutions, the CDMO that encountered problems making Covid-19 vaccines intended for US supply.

Endpoints spoke with Phlow about drug manufacturing in the US.

Inside Health Policy looked at efforts to ensure the US FDA has sufficient resources for facility inspections outside the country.

The Pink Sheet analysed new PIC/S guidance on “fool-proof” approaches to the management of drug and API manufacturing data.

Novartis has refiled its cholesterol lowing drug Leqvio (inclisiran) in the US, listing its own facility in Schaftenau, Austria as the manufacturing site. The change was made after issues were detected at the firm’s CDMO.

CDMO trends

Some developments of note in the contracting sector:

Thermo Fisher has partnered with the University of California, Davis (UC Davis) West Coast Metabolomics Center to set up the Center of Excellence in Clinical Metabolomics. The aim is to provide the metabolomics services to firms running trials.

Avid Bioservices has appointed Esther Alegria – a 30 year industry veteran who has worked at Biogen and Wyeth and is currently APIE Therapeutics’ CEO – to its executive board. See press release.

Fujifilm has announced plans to invest $850million in its CDMO subsidiary, Fujifilm Diosynth Biotechnologies. The plan is to increase biologics and vaccine capacity at facilities in the UK and US.

CDMO AGC Bio has picked up a second site in Colorado, buying a cell and gene therapy facility in Longmont from Novartis according to Bioprocess Insider.

The United States Pharmacopeia (USP) has bought Pharmatech Associates, a life sciences consulting group, to expand the range of services it offers to drug and device firms.

Sartorius Stedim Biotech has acquired a majority stake in the reagent manufacturer CellGenix GmbH.