Facilities & Capacity

From flu jabs, to mAbs, to COVID collabs: BioNTech nabs Novartis plant and labs

BioNTech is buying Novartis’ facility in Marburg, Germany to support the manufacture of its mRNA vaccine candidate against COVID-19. Financial details of the acquisition have not been divulged, but the GMP facility in Marburg (about 50 miles north of Frankfurt) will be used to increase manufacturing capacity for BNT162b2, a Phase III messenger RNA (mRNA) vaccine in development with Pfizer against COVID-19. The Novartis facility houses equipment to produce recombinant proteins, and cell and gene therapies – as well as…

Moderna says ‘simple’ mRNA process allowed speedy COVID vaccine scale-up

The cell-free and enzymatic nature of its mRNA technology has allowed Moderna to quickly build a relatively small network capable of supporting commercial manufacture of its COVID-19 vaccine. On Monday, President Trump named Pfizer and J&J as leading the way in bringing a coronavirus vaccine to market. But also speaking Monday, Tal Zaks, chief medical officer at Moderna Therapeutics, believes it will be his firm that will be the first to bring both a vaccine to market and “to deliver…

Samsung Bio adds another Big Pharma customer with $331m AstraZeneca deal

AstraZeneca will grow its production network into Asia-Pacific through a contract with Korean CDMO Samsung Biologics for large-scale drug substance manufacturing. Anglo-Swedish pharma firm AstraZeneca is teaming with contract development and manufacturing organization (CDMO) Samsung Biologics in a long-term deal worth an initial $330.8 million, though this could rise to $545.6 million. The specific products to be made at Samsung Biologics’ site in Incheon, South Korea have not been disclosed but AstraZeneca has numerous biologics commercially available and a number…

Takeda opens MA manufacturing unit to support cell therapy R&D

The 24,000 square-foot cell therapy manufacturing facility will produce material through to Phase IIb trials, supporting Takeda’s cell therapy ambitions. In 2019, Takeda expanded its presence in the oncology cell therapy space inking a series of deals and establishing an internal translational cell therapy engine. To support this, the firm invested in a cell therapy manufacturing center at its R&D headquarters in Boston, Massachusetts which opened this week. “The R&D cell therapy manufacturing facility will produce cell therapies for clinical…

Novavax teams with Serum for mass vaccine supply: ‘We can’t do that, they can’

Novavax has contracted India’s Serum Institute to make more than a billion doses of its protein-based COVID-19 vaccine candidate, pushing total capacity to 2 billion doses across its network. NVX-CoV2373 is a potential vaccine against the COVID-19 consisting of a prefusion protein made using Novavax’ nanoparticle technology based on infecting Sf9 insect cells with baculovirus viral vectors that express the SARS-CoV-2 spike protein. The vaccine is also being tested with Novavax’ Matrix M adjuvant, a saponin-based adjuvant that acts in…

Moderna: How to make 1 billion doses of a COVID-19 vaccine

The right levels of capacity, equipment, staff, and raw materials are key in scaling up COVID-19 vaccine manufacturing says Moderna, which is moving towards making one billion doses of its mRNA candidate. Moderna Therapeutics’s mRNA-1273 is one of the frontrunners in the rush to develop a vaccine against COVID-19. The candidate is in Phase III trials and as such Moderna has focused much of its attention on building up its manufacturing capabilities to produce millions of doses, with a target…

Manufacturing shift to Ireland frees up US capacity for Regeneron’s COVID antibodies

Regeneron is shifting production of non-COVID therapies from its US facilities to its site in Limerick, Ireland to make space for a potential antibody cocktail against COVID-19. Regeneron’s efforts to combat COVID-19, caused by the novel coronavirus (SARS-CoV-2), is a monoclonal antibody (mAb) cocktail treatment based on potency and binding ability to the SARS-CoV-2 spike protein. The prospective therapy, REGN-COV2, developed using technology and experience demonstrated by the firm’s investigational triple antibody cocktail treatment for Ebola REGN-EB3, is is in…

ADC approval flurry a driver in MilliporeSigma $65m WI expansion

With five US FDA approvals over the past 15 months, MilliporeSigma says it is confident that antibody-drug conjugates (ADCs) will continue to be a driver of new therapeutics for years to come. A $65 million expansion in Wisconsin aims to exploit this. The Madison, Wisconsin expansion will bring MilliporeSigma’s contract manufacturing wing large-scale manufacturing capacity for high-potent active pharmaceutical ingredients (HPAPIs). The 70,000 square-foot facility will be designed to handle single-digit nanogram occupational exposure limit materials and will incorporate containment…

Catalent investing $130m to up US gene therapy capacity

Catalent will add five additional Phase III through to commercial-scale manufacturing suites to its gene therapy campus in Harmans, Maryland. The US contract development and manufacturing organization (CDMO) cited growing customer pipelines and an increase in demand as the driver for the investment. Randy Hendrickson, VP Commercial Operations, Catalent Cell & Gene Therapy told us: “Upon completion in the first half of 2022, the facility will house multiple cGMP manufacturing suites with pre-seed, bioreactor, and downstream rooms alongside fill/finish, testing,…

Bridgewest gains CDMO biz through Pfizer pegfilgrastim plant buy

Bridgewest Group will manufacture products for previous owner Pfizer among others after acquiring a microbial manufacturing plant in Adelaide, Australia. Bridgewest Group has made numerous investments in life sciences companies, but the acquisition of the Pfizer facility in Adelaide by subsidiary Bridgewest Australia Holdings marks the first expansion into the contract biologics space. Previous investments include antibody developer BioAtla and third-party pharma services firm BioDuro. According to Ian Wisenberg, CEO of Bridgewest Australia Biotech, the biologics contract development and manufacturing…