Wednesday, November 13, 2019 Daily Archives

Aseptic Filling for Gene Therapies and Next-Generation Biologics Within Closed Robotic Workcells

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This webcast features: Thomas Page, PhD, Vice President, Engineering and Asset Development, FUJIFILM Diosynth Biotechnologies Fujifilm Diosynth Biotechnologies (FDB) sought to “close the loop†by keeping all upstream and downstream aseptic processing operations within closed systems. The missing part was downstream, where FDB implemented a closed robotic filling workcell for manufacturing gene therapies. Workcells solve long-standing problems with sterility assurance, containment, and process control in aseptic filling. The knowledge developed by FDB during its implementation and early use of a…

November 13, 2019

Abuse in cell banking services a global problem, says industry consortium

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The International Society for Cell and Gene Therapy (ISCT) has formed a consortium to tackle what it says is a rising number of unscrupulous and unproven cell banking players. With the rise of interest in the cell and gene therapy sector, industry and the market have been plagued with unproven products and services from rogue actors looking to profit from ill-informed and sometimes desperate patients. The US Food and Drug Administration (FDA) laid down a framework to tackle unapproved stem…

November 13, 2019

Horizon Discovery divests animal model biz to focus on cell lines

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Envigo will acquire the rodent model business from Horizon Discovery for an undisclosed fee. The unit brought in £4.6 million ($5.9 million) of revenues in FY18. All assets and employees working at Horizon Discovery’s in vivo research model facilities in Boyertown, Pennsylvania and St Louis, Missouri, will be transferred to contract research organization (CRO) Envigo for an undisclosed nominal consideration satisfied in cash. “In vivo employs 46 people and generated £4.6 million in fiscal year 2018, and contributed an adjusted…

November 13, 2019

AGC Bio to plough $18m in US and EU facilities

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CDMO AGC Biologics will invest 2 billion Yen ($18.4 million) to increase biopharmaceutical production capacity at facilities in the US and Europe. The plan will see the contract development and manufacturing organization (CDMO) add a 500-liter bioreactor for mammalian cell cultures at its facility in Seattle in the US. The firm said “this will serve better, pharmaceuticals companies with biopharmaceuticals at the earlier stages of development and clinical trials.†It will also install a purification line at its manufacturing plant…

November 13, 2019