In this week’s news, the US FDA finalizes labeling guidelines for “complicated” drugs, Propharma sets selection criteria for CDMOs, and more.
Tech expertise is key when choosing a CDMO 

Propharma Group has outlined success factors for choosing a cell and gene therapy CDMO.

The regulatory consultant identified seven critical steps pharmaceutical companies should take when choosing a contractor, with technical expertise being the most important factor.

Author Justyna Piasecka, a consultant at Propharma, writes “You need a competent, trustworthy, and flexible partner who is ready for new challenges and is going to satisfy your product’s needs. A great CDMO should also be an advisor as the partnership is going to benefit you both.”

See the full list here.

Lotte plans to expand workforce at ex-BMS plant

Lotte Biologics says it will add about 70 jobs at the plant in Syracuse from BMS according to reports in the local press.

The firm – which bought the facility as part of an effort to expand its CDMO business – also plans to pump around $77 million into the plant to boost capacity for its contract manufacturing ambitions according to Korean news outlet Chosun Biz (here in Korean). 

US FDA finalizes labeling guide for complication products

The US FDA has finalized guidance on the content and format of labeling for drugs and biologics.

The guidance – available here – covers drug and biological products as well as combination products. It specifies that the label “is written for patients who use drug products that have complicated or detailed patient-use instructions.”

Also in the news

RAPS reported that EMA efforts to involve other regulators in decision-making have been a success according to a new review.

The Irish Times reported that AstraZeneca plans investment at its Irish plants in Blanchardstown and Athlone, which are run by its Alexion rare disease drug unit.

Novartis announced it has restarted radioligand therapy (RLT) production at its sites in Ivrea, Italy, and Millburn, New Jersey. The firm said it has fixed the issues that led to a suspension of production in May. 

Vedanta Biosciences has opened a new facility designed to manufacture clinical and commercial supply for its therapeutic portfolio, including for the planned Phase 3 study and potential commercial launch of its lead candidate, VE303, in Clostridioides difficile infection. 

The Pink Sheet looked at a US Government report suggesting that US FDA inspections of overseas drug manufacturing facilities.

An article by the Brookings Institute suggests that we need to update the essential medicines list to prevent future public health crises.

Samsung Biologics lays out sustainability plans in new ESG report. The company’s goal is to reduce greenhouse gas emissions, limit waste, and increase social contributions in its new report.

The medicine maker looked at why packaging should be about patients – but how can we turn a decades-old philosophy into the status quo?

According to Biopharma, BioNTech is readying to take its mRNA malaria vaccine candidates into clinical trials later this year.

Moderna’s omicron booster triggers a stronger response against subvariants than its original shot, the company says.

CDMO trends 
Some developments of note in the contracting sector: 

Lonza plans to construct a large-scale commercial drug product fill and finish facility in Stein, Switzerland. The aim is to support large-scale market supply. The new facility will cost CHF 500 million and is expected to be operational in 2026.

CoreRx will invest in capacity at its facilities in Clearwater, Florida and San Rafael, California.

Ex Lonza unit Microsize has set up as an independent company to support solubility and bioavailability enhancement via particle reduction technologies including micronization. 

Charles River Laboratories has opened its high-quality plasmid DNA manufacturing center of excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom.

Minaris Regenerative Medicine is poised to begin making REX-001, an autologous multi-cell therapy (MCT) being developed for the treatment of chronic limb-threatening ischemia (CLTI) in patients with diabetes by Ixaka. The German CDMO completed the tech transfer last month.

Vaccizone has hired Exothera to provide process development services for its SARS-CoV-2 vaccine for European clinical trials.