Therapeutic Class

Back to school: GE and UMass partner on academic viral vector plant

GE Healthcare has partnered with UMass to establish a viral vector manufacturing facility – its latest tie-in with academia in the cell and gene therapy space. The planned facility at the University of Massachusetts (UMass) Medical School’s Worcester campus will provide recombinant adeno-associated virus (AAV) vectors for preclinical research. High demand and a shortage of capabilities for viral vectors means the 3,220 square-foot facility, decked out with GE Healthcare’s viral vector FlexFactory platform, will help alleviate the current wait researchers…

Charles River bids $380m to buy cell therapy services firm HemaCare

HemaCare will boost Charles River Laboratories’ offering in the cell therapy materials and leukapheresis space – a market predicted to grow to $2 billion in the next decade. The deal will add expand Charles River’s cell therapy offering. HemaCare provides human primary cells as well as services used in the discovery, development and commercial production of cell therapies. Leukapheresis – the separation of white cells from blood samples – is a core HemaCare offering. The firm provides leukapheresis services for…

AI will help Novartis make personalized meds, says Amazon

Amazon says Novartis’ personalized medicines operations will benefit from AI and machine learning collaboration. Novartis confirmed it had asked Amazon Web Services (AWS) to rejig is supply lines last week. The drug firm said it “will leverage AWS’s broadest portfolio of cloud services to build an enterprise-wide data and analytics platform that will transform business operations. According to AWS, the plan is to use artificial intelligence and machine learning to “reimagine” the Swiss firm’s manufacturing, supply chain, and delivery operations.…

Polyplus ups reagent range to support growing CGT space

Polyplus-transfection SA has expanded its reagent portfolio, citing the growing number of candidate cell and gene therapies nearing commercialization as the driver. The French biotech launched a range of sizes of its PEIpro-GMP reagent in single-use bags and bottles this week. Transfection reagents facilitate cellular uptake of nucleic acids. Polyplus premiered PEIpro-GMP last year, marketing it as “the first transfection solution for the gene and cell therapy industry that is compliant with global cGMP viral vector manufacturing requirements.” The expanded…

Swiss site opens to boost Novartis CAR-T production

Novartis has opened a CHF 90 million ($91 million) manufacturing site in Stein, Switzerland to support its cell and gene portfolio. In August 2018, Novartis announced a Swiss facility would support production for its burgeoning chimeric antigen receptor T cell (CAR-T) products and pledged CHF 90 million in phased investments to support the project. The facility in Stein, about 20km east of Basel, opened its door last week ahead of the predicted 2020 date, bolstering the firm’s global network. “The…

Boston next-gen manufacturing hub will ease bottlenecks, consortium

Cell and viral vector backlogs reduce patient access to next-generation medicines and slow R&D says the consortium behind a $50 million innovation hub. The group, led by Harvard University, made the comments this week, explaining that while some contract development and manufacturing organizations (CDMOs) offer cell line and vector services, growing demand means developers can face delays. “Manufacturing backlogs are slowing the production of cells that are essential to research, holding up the availability of new treatments headed for the…

Lack of UK cell and gene therapy skills a concern according to CGTC survey

UK cell and gene therapy firms are worried a shortage of skilled manufacturing staff will slow growth with some concerned Brexit will exacerbate the problem. The findings come from a new skills survey by the Cell and Gene Therapy Catapult (CGTC) – an organisation set up to support the sector by non-departmental government body, Innovate UK. Of the 41 companies that responded, 98% said they planned to expand their headcount over the next five years. Of these, 83% raised concerns…

Thermogenesis cell preservation tech to drive CAR-T cancer trial eligibility

Rebranded Thermogenesis used its quarterly call to outline plan to target unmet tech and manufacturing needs in the CAR-T sector. The firm – known until November 1 as Cesca Therapeutics – will pitch its cell processing tools and its new services joint venture – Immunecyte – as a way to help reduce CAR-T manufacturing, storage and distribution costs. CEO Chris Xu told analysts on Thermogenesis’ third quarter call that Immunecyte – formed with Healthbanks Biotech last month – would be…

WuXi on board for Tychan’s yellow fever mAb

Wuxi Biologics will manufacture supplies of Tychan’s developmental yellow fever biologic for clinical trials. The drug in question – known as TY014 – is a first-in-class monoclonal antibody. It targets the envelope (E) protein on the surface of the yellow fever virus and prevents replication by limiting fusion to host cells. Earlier this month Tychan announced it had successfully completed Phase IA/IB safety studies. The firm also said it received regulatory approval to test the drug in a field study…

Fujifilm pumps $120m into US gene therapy development and manufacturing

An innovation center and additional cGMP manufacturing capacity make up Fujifilm Corporation’s plans to bolster its gene therapy capabilities at its site in Texas. It is no secret that the demand for gene therapy services is outstripping supply, with a shortage of viral vector capacity meaning contract development and manufacturing organizations (CDMOs) with manufacturing capabilities are rarely struggling to fill their space. To keep up with industry demand, Fujifilm Diosynth Biotechnologies (FDB) – the CDMO of Fujifilm Corporation – has…