Therapeutic Class

Resilience launches with $800m to ‘break’ biomanufacturing bottlenecks

Though details are scarce, Resilience claims it will provide ‘new, better, faster ways’ to manufacture cell and gene therapies. The new entity begins with bases in Boston and San Diego, as well as over 750,000-square-feet of operating space. Officially known as ‘National Resilience’, the company announced its entrance on the market by suggesting that it would be a ‘first-in-kind’ biomanufacturing and technology operation that has been set up specifically to address capacity issues in the advanced therapeutics area. Resilience plans…

64x claims cell screening tech is breakthrough for global vector supplies

64x bio says a new cell screening technology has the potential to make viral vector production more efficient. The San Francisco-headquartered biotechnology’s “VectorSelect” platform is a high throughput screening technology designed to help viral manufacturers identify high yield production cell lines. 64x bio says the system’s key feature is “genetic barcoding,” which links information on viral vector productivity to the parent cell allowing users to screen millions of candidate production cell lines at once. The aim is to help firms…

Rubius touts shelf life of cancer therapy, citing manufacturing process

Rubius Therapeutics has shared details of the manufacturing process for RTX-321, a candidate cell therapy for HPV positive cancers that it says is a “truly” off the shelf product. The US biotech made the claim in an IND filed with the FDA earlier this month. It said the “filing for RTX-321 included, for the first time, frozen drug substance as part of the manufacturing process, resulting in a truly off-the-shelf cellular therapy with a potential shelf life of up to…

Altimmune partners with Lonza on intranasal COVID-19 vaccine

The two companies ready AdCOVID for a commercial launch in 2021, with a clinical trial to begin in Q4. The next-generation of COVID-19 vaccines is already being developed, even with the first generation yet to reach the public. The companies involved are finding ways to differentiate their vaccines from the previous generation. This has led companies, such as Vaxart, to produce oral vaccine candidates and sees Altimmune further advance its intranasal vaccine candidate by signing a manufacturing deal with Lonza.…

Catalent reiterates confidence in the gene therapy sector

Gene therapies will help drive growth says Catalent, which reiterated its confidence despite recent setbacks in the sector. The contract development and manufacturing organization (CDMO) spoke about its growing gene therapy business during its first quarter earning call last week, explaining it is seeing ongoing “elevated demand” for this type of work. Revenue generated by Catalent’s biologics business – which covers biopharmaceutical manufacturing as well as cell and gene therapy production – was $377.1 million in the first quarter of…

Reliance on antiquated tech a business risk for CGT sector

Cell and gene therapy firms should swap outdated human error prone processes for innovative, flexible technologies, says consulting group CRB. The conclusion is based on the ‘Cell and Gene Therapy Industry Report,’ which included a survey of executives at firms developing advanced therapy medicinal products (ATMP). The goal was to look at the technologies and manufacturing methods used in the sector and the results suggest the sector has yet to find the best way of making products at commercial scale.…

Hyasynth harnesses biopharma processes bringing yeast-made CBD to market

Using yeast fermentation in a similar way to insulin synthesis provides a cheaper, more sustainable way to make cannabinoids like CBD, says Hyasynth. Last month, Canadian firm Hyasynth received a $2.5 milllion milestone payment for its commercialization achievements in being first-to-market with cannabidiol (CBD) produced and extracted from a biomanufacturing setup. “It’s a typical yeast fermentation, so the equipment involved would be similar to the production of insulin,” Kevin Chen, CEO of Hyasynth told this publication. “We grow the yeast…

Bluebird: CMC and COVID delays push sickle cell gene therapy BLA back to 2022

Bluebird bio has asked the US FDA to take a flexible and innovative approach to the CMC comparability data review for gene therapy candidate LentiGlobin. It had been estimated that bluebird bio was aiming to submit a Biologics License Application (BLA) for its gene therapy candidate LentiGlobin (autologous CD34+ cells encoding βA-T87Q-globin gene) in the second half of 2021. But following US Food and Drug Administration (FDA) concerns, guidance has been put back by a year, management said on a…

COVID highlighting advantage of in-house CAR-T manufacturing, says Celyad

With COVID-19 disrupting the supply chain, the advantages of inhouse manufacturing capabilities have never been so clear says CAR-T developer Celyad Oncology. In 2012, Celyad Oncology – then known as Cardio3 BioSciences – received GMP certification for its a facility in Mont-Saint-Guibert, Belgium to support its allogeneic and autologous chimeric antigen receptor (CAR) T candidates. Eight years on and in the midst of a pandemic, the decision to invest in internal manufacturing capabilities has never seemed so astute, says Celyad’s…

Novartis continues Kymriah capacity expansion with Japanese CDMO

Novartis has tripled production capacity for its commercial CAR-T therapy Kymriah over the past year and continues to ramp up through a deal with Japan’s Foundation for Biomedical Research and Innovation (FBRI). Kobe, Japan-based FBRI has received marketing authorization from Japan’s Ministry of Health, Labor and Welfare (MHLW) to manufacture Kymriah (tisagenlecleucel) for Swiss pharma giant Novartis. The approval expands the manufacturing footprint of the chimeric antigen receptor (CAR) T-cell therapy, bringing Novartis its first Asian production facility. Furthermore, according…