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Charles River: COVID forces closure of donor clinic disrupting HemaCare biz

Charles River says its cell therapy services business HemaCare is susceptible to the impact of COVID-19 and has already had to temporarily close its donor collections clinic. Charles River Laboratories acquired HemaCare for $380 million in December last year, bolstering its cell therapy services business. HemaCare provides human primary cells as well as services used in the discovery, development and commercial production of cell therapies, and provides leukapheresis services for materials used in the manufacture of Novartis’ Kymriah (tisagenlecleucel), Kite’s…

Regeneron clears capacity at NY plant in prep for COVID antibody cocktail

by Dan Stanton

Regeneron says depending on trial data it could be producing hundreds of thousands of doses of an antibody cocktail against COVID-19 by the end of summer. Regeneron was one of the first to announce its intentions to develop monoclonal antibodies (MAbs) against COVID-19, caused by the novel coronavirus (SARS-CoV-2). Using its VelociSuite discovery and development technologies and experience garnered to develop its investigational triple antibody cocktail treatment for Ebola REGN-EB3, the firm has is focused on developing a multi-antibody ‘cocktail’…

Want to keep up with demand for CGT testing? Stay nimble and invest, says Eurofins

by BPI Contributor

With record numbers of cell and gene therapies in development, Eurofins BioPharma Product Testing is investing in specialized technologies and scientific talent to tackle technical and regulatory questions around biosafety, characterization, and functionality. The advanced therapy services space is booming, riding the wave of cell and gene therapies (CGTs) entering and progressing through the clinic. While only a handful of such products have reached commercialization, the US Food and Drug Administration (FDA) anticipates numerous approvals in the coming years based…

Fujifilm Diosynth reserves space for Gates backed COVID-19 therapies

by Gareth Macdonald

Fujifilm Diosynth Biotechnologies has agreed to dedicate space at its plant in Hillerod, Denmark to the COVID-19 Therapeutics Accelerator. Fujifilm Diosynth Biotechnologies (FDB) will work with a pharmaceutical partner to support the swift manufacture of a COVID-19 therapy for patients in lower-income countries. According to the contract development and manufacturing organization (CDMO) the deal includes drug substance manufacture along with supporting drug product (DP) and assembly, label and packaging of COVID-19 therapeutics. CEO Martin Meeson told us “Under the agreement,…

Eli Lilly and AbCellera begin GMP manufacture of potential COVID-19 MAb

by Dan Stanton

Eli Lilly has three therapy programs attempting to combat COVID-19 but says its monoclonal antibody partnership with AbCellera is the most significant. In March, Eli Lilly inked a deal to codevelop antibody products for the treatment and prevention of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus, using AbCellera’s pandemic response platform. While discussing its first quarter 2020 results, Lilly described the collaboration as the “most significant program” of its active therapeutic programs it is pursuing against COVID-19 and…

Oxford University latest horse in COVID-19 race as AAV vaccine enters clinic

by Dan Stanton

The first patients have been dosed with ChAdOx1 nCoV-19, an adenovirus vaccine vector (AAV) developed by the Jenner Institute at the University of Oxford. It becomes the fifth COVID-19 vaccine to enter the clinic. Clinical trials of the vaccine, based on an adenovirus vaccine vector (AAV) and the SARS-CoV-2 spike protein, began today in healthy volunteers aged between 18 – 55 in Oxford, UK. The vaccine was developed at Oxford’s Jenner Institute and was chosen as the most suitable vaccine…

MilliporeSigma invests $110m in gene therapy CDMO biz

by Dan Stanton

MilliporeSigma is building a second facility at its gene therapy site in California, adding 11 production suites and more than doubling its viral vector capacity. The life sciences services division of Merck KGaA, MilliporeSigma, has been involved in the gene therapy area since 1997 through its site in Carlsbad, California. In 2016, the company expanded the site from 44,000 square feet to 65,000 square feet to meet growing demand for viral and gene therapy products. Now the firm has announced…

Avectas attracts $20m to scale-up non-viral cell engineering tech

by Gareth Macdonald

Avectas has secured funds needed to scale-up its cell engineering technology and expand its teams in the US and Ireland. Dublin-based Avectas attracted $20m of equity investment in a series C fundraising round completed on April 16. The firm plans to use the funds to scale up its Soluporation technology and to expand its commercial, regulatory and technical organization within Ireland and the US. CEO Michael Maguire told us “We will accelerate our translation and scale-up by engagement with external CDMOs and…

FairJourney and Iontas: Speed and collaboration key to developing coronavirus antibodies

by Dan Stanton

Antibodies must be developable and manufacturable say FairJourney and Iontas, the latest partnership aiming to bring a therapy against COVID-19 to fruition. Recently we published a comprehensive guide to all the antibody-based therapies being developed to treat COVID-19, caused by the novel coronavirus (SARS-CoV-2). The latest firms looking to this modality in the battle against the virus are UK-based biotech Iontas and Portugese contract research organization (CRO) FairJourney Biologics, which announced a partnership to combine the latter’s phage display antibody…

COVID-19 pipeline: Industry flexing its Abs in fight against coronavirus

by Dan Stanton

From Regeneron to GSK, monoclonal to bispecific, industry is increasingly looking at antibody (Ab) therapies to tackle the novel coronavirus. We bring you a comprehensive guide to what’s in the pipeline. Only six weeks ago, Bioprocess Insider brought to you a highlights reel of the treatments and prophylaxis in the development pipeline to treat COVID-19, caused by the novel coronavirus (SARS-CoV-2). But six weeks is a very long time in a global pandemic, and since then new projects have begun…