In this week’s news, industry preps for EU micro-plastics rules, US FDA wants more funding and more.

US FDA asks for more cash for pandemic prep and inspection expansion

The US FDA has asked for an $8.4 billion allocation in President Biden’s FY2023 budget, citing the need to prepare for future pandemics as a basis for the request.

The request – which is a $2.1 billion (34%) increase on the amount the agency asked for in 2022 – would fund “investments in critical public health modernization, core food safety and medical product safety programs and other vital public health infrastructure.”

The FDA also requested $24 million to optimize inspections and enhance inspectional capacity, citing a need for new inspectors and technology.

It wrote, “With additional personnel, as well as expanding the use of new and existing inspectional tools, the FDA will enhance its inspectional capacity and build on the efforts to keep pace with the rapidly expanding industry including medical countermeasures and advanced manufacturing.”

Excipient sector publishes micro-plastics guide

Excipient industry group IPEC has released a guide to industry complying with new labelling and reporting rules for micro-plastics.

The new guide “summarizes the core elements of the restriction proposal and intends to provide guidance for excipient manufacturers and users on how to prepare for compliance,” according to IPEC.

The European Chemicals Agency (ECHA) developed the new rules as part of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation in response to environmental concerns about micro-plastics in medical products.

Also in the news

Bioprocess Insider reported that the US FDA has set a 15 year follow-up period for therapeutic gene editing and edited products in new draft guidelines.

EU biotechnology companies are in a fight for financial survival according to a report by Scrip.

STAT reported that Aurobindo will close a key US production plant.

Gilead plans to close an Immunomedics plant in New Jersey according to Bioprocess Insider.

US drug company Merck & Co is to stop making APIs at its facility in Pennsylvania and cut 300 jobs by 2024 according to Endpoints.

Jazz Pharmaceuticals has started construction of a manufacturing facility at Kent Science Park (KSP) in Sittingbourne. See press release.

The WHO announced that Egypt’s and Nigeria’s medical products regulatory agencies had reached maturity level 3, meaning they could be eligible for inclusion into the transitional Listed Authorities, a list that will comprise the world’s regulators of reference.

CDMO trends

Some developments of note in the contract services sector: 

Oasmia Pharmaceutical AB has hired Lonza to make the main drug intermediate in the supply of clinical material for its investigational drug candidate, Cantrixil.

Fujifilm Irvine Scientific will acquire Shenandoah Biotechnology, a manufacturer of recombinant proteins. 

Active ingredient maker Seqens has announced plans for a multi-million-dollar investment in its research and development laboratory located in Devens, Massachusetts.

Akron BioProducts and Vor Bio have formed an agreement to develop and manufacture cGMP nucleases for use by the cell and gene therapy manufacturing industry.

LifeMine Therapeutics has announced a strategic R&D collaboration with GSK. LIfeMIne will provide access to its genomically enabled drug discovery platform to identify novel small molecule leads directed to up to three human targets.

IPI’s latest publication announces how Tjoapack will consider when to automate packaging lines and how to balance the design and flexibility of lines to serve all the needs of different customers.