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…
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…
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 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 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 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 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…
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…
New deals inked by AGC Biologics, Avid Bioservices, and Therapure, while Fujifilm breaks ground in Texas. Welcome to Friday’s CDMO round-up. AGC Biologics has been contracted by Japan’s Ono Pharmaceutical for the manufacture of clinical materials. Details are scant but the agreement marks the latest deal announced by the contract development and manufacturing organization (CDMO) in recent months. Since the coronavirus pandemic began, AGC has been named as one of the manufacturers of Novavax’s COVID-19 vaccine candidate NVX-CoV2373; recently said…
Agilent Technologies has announced plans to more than double nucleic acid-based drug production capacity at its facility in Frederick, Colorado. The research, development and manufacturing company said it will invest $150 million to add 25,000 square feet of capacity. Agilent cited the growing market for “oligos†as the driver for the investment, predicting it will grow in double digits and be worth more than $750 million by 2025. Sam Raha, president of Agilent’s Diagnostics and Genomics Group, said, “Adding this higher-volume…