Facilities & Capacity

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…

Catalent cites biologics as growth driver and forecasts COVID gains in 2021

Catalent says investments in biologics – particularly in the cell and gene therapy space – drove Q4 gains and positioned it as the “go to” COVID CDMO. Catalent’s revenue for the three months ending June was $947.6 million, up 31% on the comparable quarter last year. The contract development and manufacturing organization (CDMO) made a number of purchases in the cell and gene therapy space in recent years. In February, it bought Masthercell from Orgenesis and in 2019 it acquired…

Maravai invests further $20m in CDMO biz on back of rising mRNA interest

Maravai LifeSciences has increased investment in its CDMO business TriLink BioTechnologies to $60 million as mRNA, CRISPR and advanced therapies drive demand. Maravai LifeSciences acquired the contract development and manufacturing organization (CDMO) TriLink in 2016, adding messenger RNA (mRNA), oligonucleotide and plasmid production capabilities for companies focused on therapeutic, vaccine and diagnostic development. Last year, Maravai announced it was expanding TriLink, leasing a new facility in the Sorrento Valley area of San Diego and relocating its current Good Manufacturing Practice…

AstraZeneca ups Catalent contract for viral vector COVID-19 vaccine

Already contracted for fill/finish of the so-called Oxford Vaccine, CDMO Catalent will now make the drug substance for the potential COVID-19 prophylactic from its site in Maryland. AZD1222 – previously known as ChAdOx1 nCoV-19 – is one of the leading vaccines against the coronavirus SARS-CoV-2 that causes COVID-19. Developed by the Jenner Institute and the Oxford Vaccine Group at the University of Oxford, Anglo-Swedish Big Pharma firm AstraZeneca partnered on the project in April and the candidate is currently in…