Author Archives: Dan Stanton

Want investment and innovation? Call yourself a ‘biopharma’ firm

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With consistent year-on-year growth of around 12%, biopharma is the ‘favored child’ of the drug industry, says BioPlan Associates’ Eric Langer. At the first BIOLive event at CPhI Worldwide in Madrid this week, Eric Langer, president and managing partner at BioPlan Associates, told delegates innovation and sales revenue have driven the divide between the biopharma (large molecule) and the traditional small molecule pharma industries. “Today’s market is around $250 billion in biopharma sales, and this is still an emerging market…

October 10, 2018

4D bioprinting and stem cells: Firms look to alternatives to animal testing

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Servier will use 4D bioprinting technology to imitate human liver tissue in vitro, while STEMCELL Technologies is commercializing human pluripotent stem cell-derived kidney organoids. But can these models replace animal testing in preclinical research? French drugmaker Servier has (bio)inked a deal with Poietis to use its 4D bioprinting technology for the development and production of liver tissues. The tissue will be used to imitate human liver tissue in vitro in Servier’s preclinical testing. Poietis’ technology works through the “layer-by-layer additive…

October 10, 2018

Hoba (cell) banks on Selexis to advance neuropathic pain program

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Selexis will use its SUREtechnology platform to develop a research cell bank to help advance Hoba Therapeutic’s neuropathic pain candidate HB-086. The Danish firm Hoba Therapeutics has selected cell line development firm Selexis to help express viable levels of its clinical candidate HB-086 (recombinant human Meteorin) in Chinese hamster ovary (CHO) cells. The candidate is a 31 kD secreted protein that promotes neurite outgrowth and glial differentiation in the central nervous system. “We do not have a conclusive scientific explanation…

October 9, 2018

Yescarta: Gilead boasts 60 CAR-T clinics and counting

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There are now 60 different centers certified to administer CAR-T therapy Yescarta says Gilead Sciences says, which plans to add more as further indications are approved. In October 2017, the US Food and Drug Administration (FDA) approved the second chimeric antigen receptor T-cell therapy in the form of Yescarta (axicabtagene ciloleucel), developed by Kite which had recently been acquire by Gilead Sciences for $11.9 billion (€10.2 billion). Yescarta is made by isolating peripheral blood mononuclear cells – including T-cells –…

October 5, 2018

Bayer restructures factor VIII manufacturing, cuts 17% of jobs at Cali site

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Bayer will axe 227 jobs at its Berkeley, California site as it looks to restructure its recombinant factor VIII manufacturing network. The news comes weeks after its hemophilia treatment Jivi received US approval. Recombinant factor VIII protein (rFVIII) is used for the treatment of hemophilia A and employs genetically modified cells in its production. Bayer’s plant in Berkeley, California, is responsible for producing all three of its rFVIII therapies, including Jivi, a pegylated, longâ€acting plasma/albumin free, fullâ€length rFVIII. The product…

October 5, 2018

Pandion selects Just to cut cost of bispecific Ab development

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Just Biotherapeutics says smart design and optimization of the molecule and the manufacturing process will speed the development of Pandion Therapeutics’s lead bispecific antibody PT101. Just Biotherapeutics has entered into a master services agreement for the development and clinical manufacturing of Pandion Therapeutics’ lead candidate. Pandion is a biotech located in Cambridge, Massachusetts developing bispecific antibodies for the tissue-specific treatment of patients with autoimmune and inflammatory diseases and organ transplants. The firm completed a $58 million (€50 million) Series A…

October 3, 2018

Novartis buys 9% stake in Chinese Kymriah manufacturing partner

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Novartis has paid $40 million for a 9% stake in Cellular Biomedicine Group (CBMG), a Shanghai-based firm which will manufacture CAR-T cell therapy Kymriah for the China market. Under terms of the deal, CBMG will take responsibility for the manufacture of the chimeric antigen receptor (CAR) T-cell therapy Kymriah (tisagenlecleucel) from its facility in Shanghai, China, on behalf of Novartis entity Beijing Novartis Pharma for supply in China. “Aligned with our global supply and regulatory strategy, Novartis actively has been…

October 2, 2018

The POD couple: Pall and G-CON team on modular cleanrooms

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Pall’s continuous bioprocessing technologies will be incorporated into G-CON’s prefabricated ‘POD’ cleanroom units in efforts to address current capacity constraint, CAPEX deferment, and cost predictability. G-CON’s PODs are mobile cleanroom units, which include integrated process piping and heating and air conditioning (HVAC) system. A collaboration with bioprocessing vendor Pall Biotech will bring its continuous bioprocessing and viral vector production designs, including automation and utility supplies, to the units. The partnership sets out to solve three needs: contract development and manufacturing…

October 2, 2018

Emergent extends ABEC disposable deal to equip Maryland plant

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Emergent BioSolutions has extended its partnership with vendor ABEC and added a dual purpose single-use system at its site in Baltimore, Maryland. ABEC has shipped a custom designed CSR (Custom Single Run) dual purpose single-use system to Emergent’s Bayview facility, intended for large scale microbial fermentation and mammalian cell culture. “A CSR dual purpose system can operate as a 750 L production microbial fermenter or as a 500L seed bioreactor for Emergent’s 4,000 L CSR bioreactor,†ABEC spokesperson Susan Cooper-Curcio…

September 28, 2018

Hey Praesto: Purolite opens Protein A plant, opens up resin market

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Purolite says its 100,000 L facility will give biomanufacturers the “only credible alternative†for the supply of agarose Protein A resin. The firm claims its chromatography resins can reduce costs by up to 70% compared to the market leading product. This week, Purolite Life Sciences cut the ribbon at a manufacturing facility in Llantrisant Business Park, Wales capable of producing 100,000L of its Praesto range of agarose Protein A affinity resins. Supported by a Welsh government grant, the facility is…

September 28, 2018