In this week’s news, WHO calls for regulator alignment on cell and gene therapy production, US FDA extends inspection halt and more.

WHO proposes “risk-based” model for cell and gene therapy development

The WHO says cell and gene therapy makers should consider a risk-based approach for the development and production of such products.

The Geneva-based organisation proposed the idea in a white paper this week, arguing that the approach would “promote global convergence among health authorities.”

It suggests, for example, that autologous human cell and tissue (HCT) products be designated for a lower level of regulatory control than advanced therapy medical products (ATMPs), such as cell and gene therapies.

The WHO wrote that, “In contrast to HCTs that are minimally manipulated and undergo homologous use, ATMPs are more complex because they require controlled steps for manufacturing and significant manipulation of the cellular or genetic starting material for the intended effect.”

US FDA to extend plant inspection suspension due to omicron

The US FDA has extended its inspection halt as a result of the coronavirus omicron variant.

The regulator announced the decision this week, telling RAPS that it would extend the inspection halt for non-mission-critical domestic surveillance inspections through until February 4. Originally the FDA said it planned to resume local inspections on January 19.

Also in the news

Growth of the CDMO market is expected to continue into 2022, according to a report by DCAT.

The Pink Sheet looked at how regulators are using novel methods to carry on “inspecting” drug and API manufacturing facilities under new, pandemic-related restrictions.

US Politicians from both sides of the divide want to introduce laws to determine how reliant the country is on drugs and ingredients made overseas. See press released here.

US publication the Hill reported that the WHO believes the COVID-19 pandemic could be stopped this year.

“Patent thickets” are limiting access to generic biopharmaceutical drugs in the US according to analysis by STAT.

Unilever has given up on plans to buy GSK’s consumer healthcare products business, according to the Wall Street Journal.

CDMO trends

Some developments of note in the contracting sector

Avid Bioservices has opened a second downstream processing suite at its facility in Myford North in Tustin, California.

Sterile injectables CDMO Incog BioPharma Services has announced it is close to completing the construction of it’s manufacturing facility and global headquarters in Fishers, Indiana.

Piramal Enterprises Limited’s Pharma Solutions business has added development and commercial-scale roller compaction technology to its Sellersville, Pennsylvania drug product facility.

Catalent has increased cold chain packaging capabilities at its Philadelphia facility to support increased demand for the distribution of biologic drugs, and advanced cell and gene therapies.

Cambrex has made over $100 million of investments in progress across its global manufacturing network, according to a company press release.

Pharmaron Beijing Co has acquired Aesica Pharmaceuticals Limited from the Recipharm group. Read the press release.

Procaps Group has bought a pharmaceutical production facility located in West Palm Beach, Florida with production capacity of approximately 1.8 billion capsules per year.

Gene therapy CDMO Forge Biologics has announced manufacturing expansion plans to meet the growing demand. See press statement.