Author Archives: Millie Nelson

Adverum: ‘Scarcity of AAV capacity drove inhouse investment’

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Adverum has invested $80 million into a North Carolina viral vector facility to support gene therapy candidate ADVM-022.  The GMP adeno-associated virus (AAV) manufacturing facility will be in Durham, North Carolina. Once operational in 2023, the 174,000 square-foot facility will boast 4,000 L of bioreactor capacity and create 200 jobs. The inhouse facility will support large-scale production of Adverum’s ADVM-022, which is a potential gene therapy using “a single intravitreal injection targeting two mass markets – wet AMD and diabetic…

January 15, 2021

Moderna has the capacity but cannot guarantee the supply of COVID-19 vaccine

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Moderna says it has the capacity to deliver one billion doses of COVID-19 vaccine, mRNA-1273 but is concerned with raw material supply. Moderna has an approved vaccine for COVID-19 in the US, Europe and UK. Speaking at the 39th Annual JP Morgan virtual Healthcare Conference, CEO Stéphane Bancel highlighted how potential shortages of material could delay manufacture despite Moderna “structuring the company to deliver a billion doses†in a year. “I think sometimes people confuse capacity and supply†said Bancel,…

January 14, 2021

Merck to scale-up acquired COVID candidate to meet OWS goal

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Merck & Co. may look to repurpose some US facilities to support production of potential COVID-19 therapy MK-7110. In December 2020, the US Department of Health and Human Services (HHS) struck a $356 million deal with Merck & Co (known as MSD outside North America) to support production of MK-7110, a recombinant protein in Phase III trials as a therapy to treat hospitalized patients with acute COVID-19. When announced, HHS said the Operation Warp Speed (OWS) collaboration was the latest…

January 13, 2021

Moss-based expression firm receives €60m in funding

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German biotech Eleva has received funding to advance its candidate CPV-101, produced using a moss-based expression system. Venture capitalist firm Zukunftshonds Heilbronn has invested up to €60 million ($73 million) in funding to progress drug candidate CPV-101 through the clinic. A spokesperson for Eleva told us “we are developing CPV-101 for kidney-associated complement diseases such as aHUS, IgA Nephropathy, PNH, C3G.†The firm has developed a manufacturing process that produces biopharmaceuticals using moss called BryoTechnology. Eleva told BioProcess Insider “fermentation…

January 11, 2021

Recipharm to supply fill-finish for Moderna’s COVID vaccine

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Moderna has collaborated with CDMO Recipharm to support formulation of its COVID-19 vaccine, mRNA-1273. The vaccine was approved for emergency use in the US in December, and today the European Medicines Agency has recommended the vaccine for authorization. Recipharm is set to join Moderna’s network of contract development and manufacturing organizations (CDMOs) to support mRNA-1273, a cell-free COVID-19 vaccine which, based on evidence from clinical trials, is 94.1% effective at protecting people from SARS-CoV-2. The terms of the agreement have…

January 6, 2021

Inovio contracts Kaneka for plasmid DNA COVID vaccine

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Inovio has partnered with plasmid manufacturer Kaneka Eurogentec to support the production of its COVID-19 vaccine candidate, INO-4800. Kaneka Eurogentec, an affiliate of Kaneka Corporation, will join Inovio’s growing network of contract development and manufacturing organizations (CDMOs) to support INO-4800, a COVID-19 plasmid DNA-based vaccine, set to move into a Phase II/III clinical trial. The biotech has not disclosed the terms of agreement. However, Inovio’s CEO, Joseph Kim, said that “Kaneka Eurogentec will be a crucial member of Inovio’s global manufacturing…

December 17, 2020