Author Archives: Millie Nelson

Selecta conducts manufacturing review as it takes over MMA program

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Selecta Biosciences will review a manufacturing issue stemming from a third party after taking over the rights to an methylmalonic acidemia (MMA) gene therapy program. Selecta Biosciences and Asklepios BioPharmaceutical (AskBio – acquired by Bayer in October 2020) entered a joint partnership in August 2019 to advance, produce and commercialize adeno-associated virus (AAV) gene therapies using technology platforms from both firms. While both companies’ will continue their collaboration to assess various gene therapy candidates, after a review of its portfolio…

May 5, 2021

Lack of AAV capacity drives $120m investment for Forge Biologics

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Forge Biologics has closed $120 million in Series B financing to expand its AAV manufacturing capabilities and develop gene therapies. The gene therapy contract development manufacturing organization (CDMO) Forge Biologics has raised $120 million with finances led by RA Capital Management, Octagon Capital, Surveyor Capital (a Citadel company), and Marshall Wace. According to Forge, the funding will fast-track the expansion of its adeno-associated virus (AAV) manufacturing CDMO capabilities and capacity and work with its subsidiaries that are developing AAV gene…

May 4, 2021

GSK says 47% drop in Shingrix sales is down to COVID-19

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The coronavirus pandemic and rapid rollout of COVID vaccines in the US has led to a decline in sales of shingles vaccine, Shingrix. For the quarter, GlaxoSmithKline (GSK) reported its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster), Shingrix sales have declined by 47%, which the firm predicted during its last quarterly earnings call. “The prioritization of the public health systems to focus on pandemic vaccination deployment has led to significant disruption in Shingrix prescriptions,†Luke Miels,…

May 3, 2021

Samsung Biologics and TG Therapeutics expand mAb manufacturing contract

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Samsung Biologics and TG therapeutics have expanded their existing contract to manufacture Ublituximab, a monoclonal antibody drug to treat multiple sclerosis.  Korean Contract development manufacturing organization (CDMO) Samsung Biologics and US-based firm TG Therapeutics have expanded their 2018 contract to produce TG’s ublituximab (TG-1101), a monoclonal antibody (mAb) that targets an epitope on CD20-expressing B-cells. Samsung Biologics did not divulge ublituximab’s manufacturing process due to client confidentiality. However, a spokeswoman for the firm told BioProcess Insider it will “offer large-scale…

April 30, 2021

Moderna invests to increase global COVID-19 vaccine supply

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Moderna will make additional investments to increase global supply of its COVID-19 vaccine to potentially three billion doses in 2022. While no financial details of the investment have been divulged, the firm has confirmed it will provide additional funding to increase supply at its partnered and owned manufacturing sites this year with production expected to grow in late 2021 and early 2022. The increased investment will double drug substance manufacturing at CDMO Lonza’s plant in Visp, Switzerland. Lonza partnered with…

April 29, 2021

Avectas to develop cell engineering technology for CGT space

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Avectas has received funding to develop a cell engineering technology platform to manufacture ‘off-the-shelf’ cell therapies for cancer treatment. Irish cell engineering firm Avectas is leading a project in partnership with the National Institute for Bioprocessing Research and Training (NIBRT) and Bluebridge Technologies, which will invest $8.7 million – including $5.3 million awarded by the Irish Government’s Disruptive Technology Innovation Fund (DTIF) – to develop the cell engineering platform Solupore. “Solupore is a comprehensive end-to-end cell engineering platform that comprises…

April 29, 2021

Sanofi to fill-finish up to 200m doses of Moderna’s COVID vaccine

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Sanofi will supply fill-finish services for up to 200 million doses of Moderna’s COVID-19 vaccine mRNA-1273. French pharma giant Sanofi will use its site in Ridgefield, New Jersey to support manufacturing of Moderna’s cell-free COVID-19 vaccine, 1273, approved under Food and Drug Administration (FDA) emergency authorization. According to the firm, it could help manufacture up to 200 million doses of the COVID-19 vaccine starting from September 2021 through to April 2022. “While our utmost priority remains to advance our two COVID-19 vaccine…

April 28, 2021

Regeneron rejigs plans to build preclinical facility in NY state

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Regeneron is reportedly injecting $480 million in a planned expansion at its campus in Greenburgh, New York including a preclinical manufacturing facility. According to various publications such as Westfair Online and Real Estate In-depth, Regeneron has designed a $480 million preclinical manufacturing facility at its Tarrytown campus in New York and proposed it to Westchester County’s Industrial Development Agency (IDA). The reported plan to build a 207,000 square-foot laboratory is said to have been amended from an initial proposal that…

April 27, 2021

BMS to build fifth cell therapy plant in response to CAR-T success

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After recent CAR-T cell therapy success, Bristol-Myers Squibb will build its fifth advanced therapy manufacturing plant in Leiden, The Netherlands. The biopharma giant has invested in its fifth cell therapy manufacturing plant in Leiden, Netherlands. The plant will be its first in Europe alongside global manufacturing partnerships. The investment is part of its continued commitment to growing its cell therapy franchise and patients with haematological cancers. “At the heart of Bristol Myers Squibb’s commitment to cell therapy is our continuous…

April 26, 2021

Evotec to build $180m European biomanufacturing plant

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Evotec is set to build its second biomanufacturing J.POD facility at Campus Curie in Toulouse, France. The French facility will be Evotec’s first commercial biomanufacturing plant in Europe, with construction expected to begin during the second half of this year and the site anticipated to be fully operational in 2023. The firm will receive up to €50 million ($60m) from the French government, the Occitanie Region, the Haute-Garonne prefecture, Bpifrance, and Toulouse Métropole. However, the total investment is currently calculated…

April 23, 2021