The biopharma world's manufacturing weekly

Endpoints Manufacturing

Manufacturing channel feed

Civi­ca, Mayo Clin­ic and oth­ers sound off on FDA draft guid­ance to mit­i­gate drug short­ages

Several pharma groups are laying out the positives and negatives of new FDA draft guidance on how best to handle drug shortages.

The draft is intended to help companies develop and implement risk management plans (RMPs) to assist with any shortages of drugs or biologics. The guidance recommends a framework and factors for stakeholders to develop RMPs for their establishments, API manufacturers and others.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

To avoid short­age of Mer­ck­'s di­a­betes drug, FDA al­lows high­er im­pu­ri­ty lev­els tem­porar­i­ly

The FDA said Tuesday that it recently became aware of a nitrosamine impurity, Nitroso-STG-19 or NTTP, in certain samples of Merck’s type 2 diabetes drug Januvia.

To avoid a shortage of the drug that pulled in more than $10.5 billion for Merck in 2020 and 2021, and to help ensure patients have access to an adequate supply, the FDA said it will not object to the temporary distribution of sitagliptin containing the impurity above the acceptable intake limit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

Work­ers at Pfiz­er Aus­tralian man­u­fac­tur­ing site the lat­est to walk out in la­bor dis­pute protests

Pharma companies have been no stranger to labor disputes recently and the latest one is hitting a Pfizer manufacturing site in the land down under.

According to the United Workers Union (UWU), employees at Pfizer’s pharmaceutical manufacturing plant in the Perth suburb of Bentley have walked off for 24 hours in protest of what the union sees as a substandard pay offer for workers.

Union members said Pfizer refused to consider a wage increase in line with the cost of living. Pfizer has reportedly offered a 12% increase in wages over three years, while union members are pursuing 18%.

Joachim Kreuzburg, Sartorious CEO

On an ex­pan­sion spree, Ger­man man­u­fac­tur­er Sar­to­rius makes $500M+ pur­chase of cell cul­ture me­dia play­er

Over the past year, the German-based life science group Sartorius has made several moves to grow the company in the cell and gene therapy space, and its latest move sees the company continuing that track as it is committing to a nine-figure deal to bring UK-based Albumedix under its wing.

The deal will have Sartorius acquiring 100% of the company from private investors for £415 million, or around $502 million. Albumedix, based in the city of Nottingham, UK, is a manufacturer of albumin-based products. Albumin serves as a major ingredient in cell culture media and is used as an animal-free additive in the manufacturing of vaccines, cell therapies and viral therapies. The transaction is expected to close before the end of Q3 of 2022.

Joe Todisco, CorMedix CEO

CorMedix hit with sec­ond CRL for an­ti­fun­gal treat­ment, cit­ing man­u­fac­tur­ing and API is­sues

Following a C-suite shuffle, a shuttering of its European operations and a CRL for its treatment to prevent bloodstream infections in patients undergoing chronic hemodialysis, CorMedix is still not impressing the FDA.

The biotech has now been given a second rejection letter, as the NDA surrounding its antifungal solution, DefenCath, cannot be approved until issues surrounding its contract manufacturing organization and the supplier of the API heparin during inspections are resolved, CorMedix said Monday afternoon.

(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Man­u­fac­tur­ing roundup: So­ci­etal CD­MO nets new cus­tomers; Chime Bi­o­log­ics gets the OK to man­u­fac­ture an­ti­bod­ies

Societal CDMO has been awarded service contracts for three new customers. The agreements include an array of manufacturing services, for clinical trials, analytical methods, formulation development and cGMP manufacturing.

For the first contract, Societal will support the initiation of a Phase II clinical study of an antidepressant already approved for use in Europe and Australia. Societal will be responsible for sourcing, preparing, packaging and labeling of both the study drug and matching placebo for use in the trial. These activities will be conducted in collaboration at its facilities in Georgia and California.

FDA is­sues new guid­ance for changes to dis­pos­able man­u­fac­tur­ing ma­te­ri­als

While the FDA is stepping up inspections of manufacturing sites after Covid-19 caused delays, the regulator has issued new guidance to the industry surrounding changes regarding disposable materials.

The guidance states that any changes to disposable materials used primarily in drug and biological product manufacturing, including at contract manufacturing sites, must “be available upon request during an FDA inspection.”

Marc Casper, Thermo Fisher CEO

Ther­mo Fish­er com­pletes $76M cell cul­ture man­u­fac­tur­ing site near Buf­fa­lo, NY

Thermo Fisher has completed the expansion of one of its manufacturing facilities in New York, taking another step forward in its broader investment plan for sites in the US and globally.

The $76 million expansion of its dry powder media manufacturing facility in Grand Island, New York, just north of Buffalo, will allow more capacity to support Thermo Fisher’s global supply and extend its capabilities for materials used in vaccines and biologic therapy development and manufacturing.

Andrey Zarur, GreenLight Biosciences CEO

Green­Light Bio­sciences cel­e­brates man­u­fac­tur­ing mile­stone for Covid-19 boost­er can­di­date

It was late last year when the biotech GreenLight Biosciences inked a deal with CDMO giant Samsung Biologics to manufacture its mRNA Covid-19 vaccine. Now, as Samsung pumps more money into its biotech and CDMO operations, the South Korean company has completed the first commercial-scale engineering run for GreenLight’s Covid-19 vaccine booster candidate.

According to Samsung Biologics, GreenLight’s synthesis reaction had a titer of 12g/L at a commercial scale and produced 650g of mRNA. On the back of this test, GreenLight’s Covid booster is expected to have data later this year, with manufacturing at a commercial scale starting soon after.