Author Archives: Gareth Macdonald

Sanofi wins US HHS $226m contract to expand PA vaccine capacity

The US Government has contracted Sanofi Pasteur to increase recombinant vaccine capacity at its Pennsylvania plant as part of US efforts to prepare for a flu pandemic. The US Department of Health and Human Services (HHS) shared details of the six-year, $226 million contract this week. Sanofi will work with the Biomedical Advanced Research and Development Authority to (BARDA) double capacity at the plant. The contract includes options that would see Sanofi retrofit a second facility to make adjuvant; develop…

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.…

Zelluna and Glycostem team on natural killer TCRs for solid tumors

Zelluna Immunotherapy and Glycostem Therapeutics have teamed up to develop TCR cell therapies for cancers, including hard-to-treat solid tumors. The partnership will combine Zelluna’s T-cell receptors (TCR) with The Netherlands-based Glycostem’s umbilical cord-derived natural killer cells. The TCR-NK cells will be made at the latter’s manufacturing facility in the Netherlands. A Zelluna spokesman told us TCR-NKs can target a broader range of tumors than cell therapies made using chimeric antigen receptors (CARs). “Adoptive cell therapies, both CAR and TCR, use…

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…

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…

Blame the messenger: Novartis cites RNAi candidate in $9.7bn Medicines Company deal

Novartis’ $9.7 billion move for inclisiran developer, the Medicines Co, and US approval for Alnylam’s Givlaarim have put RNA interference back in the headlines. RNAi therapies treat disease by interfering with – or “silencing” – genes. Drugs like inclisiran and Givlaarim bind mRNA transcribed from target genes, forming double stranded molecules that cannot be translated into protein. Inclisiran’s target mRNA encodes PCSK9, a protein that hampers the body’s ability to absorb low-density lipoprotein (LDL) [1]. By minimizing PCSK9 levels inclisiran…

Purolite resin booming on biopharma uptake and ‘major’ regulatory milestone

The US FDA has approved a manufacturing process using a Purolite Praesto resin for the first time. Purolite says Janssen, Celgene and Biogen are among the firms working with its Praesto range of mAb capture resins. The separation tech firm told Bioprocess Insider about demand for its products last week, explaining that “Praesto resins are currently implemented into over 170 ongoing pre-clinical to Phase III projects at facilities across the globe. “This is a mix of standard and custom design…

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…