Author Archives: Dan Stanton

Patient Access Tops the List of Advanced Therapy Milestones at Phacilitate 2020

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In a highly anticipated presentation at the 2020 Phacilitate Leaders World event — part of Advanced Therapies Week, along with the World Stem Cell Summit in Miami, FL — Susan Nichols (chief executive officer for Falcon Therapeutics), highlighted 10 events from 2019 that drove conversation, investment, and innovation in regenerative medicine. Although clustered regularly interspaced short palindromic repeats (CRISPR), business consolidations, and production capacity powered the cell and gene therapy (CGT) space in 2019, a new proactive focus on patient…

April 14, 2020

The Technology of Tomorrow — Today

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Sponsored by BioProcess International and its sister publication BioProcess Insider, the “Tech of Tomorrow Zone†at Phacilitate 2020 played host to a number of companies showcasing platforms and ideas that they believe can revolutionize cell and gene therapy (CGT) manufacturing. Some common themes arose in this diverse zone, highlighting technologies from stem-cell supply solutions to viral-vector filling. Participating companies are aware of the complexities involved in producing regenerative medicines, and each proposed solution was intended to reduce the burden on…

April 14, 2020

Vir and GSK add CDMO Samsung Bio to COVID-19 MAb program in $362m deal

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Speed and mass production capacity are key when manufacturing potential COVID-19 treatments, says Samsung Biologics as it becomes the latest CDMO to support Vir’s SARS-CoV-2 monoclonal antibody programs. Vir Biotechnology has a technology that identifies antibodies in people who are protected from, or who have recovered, from infectious disease. The firm is using this platform to tackle the novel coronavirus, and has partnered with GlaxoSmithKline (GSK) to bring lead candidates VIR-7831 and VIR-7832 through the clinic. The company says both…

April 13, 2020

Novel R&D approaches and the need for flexibility make single-use key in tackling COVID-19

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Manufacturers are unlikely to look to traditional stainless-steel systems when developing COVID-19 vaccines despite the very high doses potentially needed, says MilliporeSigma. The list of biopharma companies rapidly developing vaccines is growing in response to the novel coronavirus (COVID-19) pandemic. Moderna Therapeutics has a messenger RNA (mRNA) in Phase I trials, Inovio Pharmaceuticals’ DNA vaccine entered human trials last week, while others including Novavax, which is developing a vaccine based on its recombinant protein nanoparticle platform, are racing towards the…

April 10, 2020

Cytiva on board for University of Queensland COVID-19 vaccine project

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Cytiva – formerly known as GE Healthcare Life Sciences – will develop a prototype affinity resin to support a COVID-19 vaccine candidate being developed by the University of Queensland A team from the University of Queensland (UQ), Australia is working on a fast-tracked vaccine for the novel coronavirus, COVID-19, using its molecular clamp’ technology. The platform tech, invented by UQ scientists and patented by UniQuest, aims to provide stability to the viral protein that is the primary target for our…

April 10, 2020

Inovio’s COVID-19 vaccine enters clinic buoyed by VGXI manufacturing success

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Inovio Pharmaceuticals has asked VGXI to scale-up manufacturing of a potential DNA vaccine against COVID-19 after an initial production run provided materials for a Phase I trial that began this week. The first dosing of INO-4800, a DNA vaccine candidate designed to prevent COVID-19, took place this week after the US Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application. The Phase I study of INO-4800 will enroll up to 40 healthy adult volunteers at the…

April 8, 2020

BAT biotech using tobacco to make COVID-19 vaccine candidate

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British American Tobacco (BAT) will use its tobacco-based expression technology to make a not-for-profit vaccine candidate targeting the novel coronavirus. The vaccine candidate has been developed by Kentucky BioProcessing (KBP), the wholly owned subsidiary of the Big Tobacco firm BAT. “KBP recently cloned a portion of the genetic sequence encoding the selected coronavirus antigen – a substance which induces an immune response in the body and the production of antibodies,†a BAT spokesperson told this publication. “This sequence was then…

April 7, 2020

Allogene turns to MaxCyte’s tech for its off-the-shelf CAR-T therapies

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MaxCyte says its clinically validated electroporation technology will help increase efficiency and improve yield of Allogene’s allogeneic CAR-T therapy candidates. Pfizer-backed biotech Allogene launched in 2018 with a focus on developing allogeneic, or off-the-shelf, chimeric antigen receptor (CAR) T-cell therapies. To achieve this, the firm has regularly stressed the importance of manufacturing, devoting “considerable time and resources†to the process. Now the firm has inked a deal to use MaxCyte’s ExPERT platform to develop and advance its candidates through to…

April 3, 2020

Akron buys Cambryn plant on back of high CGT demand

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The addition of a biomanufacturing plant in Florida will support the high demand for Akron Biotech’s cytokine and media products from the blossoming cell and gene therapy sector. Akron Biotech has expanded its operations by acquiring a biologics facility in Sarasota, Florida second manufacturing plant. The firm makes cGMP-compliant cytokines that are embedded in numerous clinical and commercial cell therapies and the addition of a second facility is needed to expand capacity to meet the tremendous demand, according to Akron…

April 2, 2020

J&J to expand vaccine capacity as part of $1bn BARDA coronavirus collaboration

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Johnson & Johnson (J&J) says it will leverage and expand facilities in The Netherlands and Pennsylvania in efforts to reach one billion doses of a potential COVID-19 vaccine. In February, J&J teamed up with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS) to develop a vaccine against the novel coronavirus (COVID-19). At the time the company said it would work to upscale production and manufacturing capacities, leveraging its AdVac and PER.C6…

April 1, 2020