Therapeutic Class

A supply chain existential crisis? Cell therapy firms must move from paper

There is an existential crisis in the cell therapy space as firms face limited and outdated options to track personalized medicines, says supply chain technology developer ATMPS. ATMPS’ software, Hataali, uses blockchain technology to track cell therapy products from the initial harvesting of cells from a clinical trial participant to the production facility and back through a series of nodes. The software received a US patent for the use of blockchain in personalized medicine earlier this year, and hopes to…

Intravacc bags two intranasal vaccine deals in one week

A $14.6 million contract for its jointly developed gonorrhea vaccine and a partnership with CEPI to advance coronavirus vaccines make a busy week for Intravacc. Dutch firm, Intravacc, and microparticulate immune therapeutics firm Therapyxpartnered in August 2020 to develop NGoXIM, a prophylactic vaccine that treats gonorrhea. This week, the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the firms a contract with base and options that could potentially total…

Ginkgo adds ‘circular’ RNA with Circularis buy

The addition of Circularis and its circular RNA technology will support growing demand for nucleic acid and advanced therapy services, says Ginkgo Bioworks. The deal, of which financials have not been disclosed, sees Ginkgo add Circularis’ promoter screening platform to its existing technology. According to Ginkgo, the platform enables ultra-high throughput screening of enhancers and promoters, and the firm sees circular RNA (circRNA) as a potential therapeutic modality. “Circularis is developing cutting edge circular RNA technology, and we expect a…

Supply chain weight grows as CGTs reach ‘critical inflection point’

Cell and gene therapy developers should start planning manufacturing and supply chains at least three years ahead of commercial launch, according to new analysis. The research – by consulting group McKinsey – said the cell and gene therapy sector is at a “critical inflection point” with regards to bringing products to market and sought to identify steps likely to increase the chance of a successful launch. And the key finding is that products for which the supply chains are planned…

Thermo Fisher launches Dynabeads tech to support mRNA production

Thermo Fisher Scientific has introduced a customized Dynabeads solutions, which it says supports synthesis and purification of mRNA for manufacturing and vaccine development. According to the firm, the Dynabeads Streptavidin for in vitro transcription and Dynabeads for carboxylic acid for RNA purification solutions can support messenger RNA (mRNA) synthesis and purification for vaccine development and production. Furthermore, Thermo Fisher says that when combined with its TheraPure portfolio of enzymes and nucleotides, it provides a simplified workflow that allows mRNA firms…

Testing times: WuXi ATU investments ready to support CGT cascade

WuXi Advanced Therapies has highlighted its expanded cell and gene therapy testing capabilities in preparation for as many as 200 products reaching the market in the next seven years. “Just 18 months ago there was a little over 1,100 compounds in development. Now there are over 2,000,” Michael Stump, executive director of Testing Operations at WuXi Advanced Therapies said at Biotech Week Boston. “Even a 5-10% success rate, we’re looking at 200 modalities coming into the market in the next…

FDA creates advanced therapies ‘super office’ to meet higher demand

The US FDA office tasked with overseeing cell and gene therapies has been renamed and reorganized in response to increased submissions. The changes – details of which were published in the Federal Register last week – saw the ‘Office of Tissues and Advanced Therapies’ become the ‘Office of Therapeutic Products (OTP)’ and will be designated as a ‘super office’ that will manage its program at a macro level. The changes – which came into effect on September 16 – will…

With MA plant operational, CRISPR lauds allogeneic cell therapy approach

CRISPR Therapeutics says pharma must realize that an allogeneic approach is the only sustainable way of “doing cell therapies across broad populations.” While the market has seen a flurry of chimeric antigen receptor (CAR) T-cell therapy approvals –  Novartis’ Kymriah (tisagenlecleucel), Gilead’s Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel), Bristol Myer Squibb’s Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), J&J’s Carvykti (ciltacabtagene autoleucel) – these have all been autologous products, made by taking, reengineering, and reintroducing a patient’s own cells.…

Platforms are pivotal to pandemic speed, says BMS

Only companies that have strong platforms will be able to meet specific timelines, says Bristol-Myers Squibbs’ Jim Xu. As COVID-19 transitions into an endemic, delegates at Biotech Week Boston discussed the challenges concerning the upstream process development process. Jianlin (Jim) Xu, scientific director, biologics development at BMS, explained told a packed room that monoclonal antibodies (mAbs) are difficult to produce with complex glycosylation profile, process related impurities, and amino acid oxidation. Xu also outlined other challenges, which included bioreactor operation…

Polyplus bolsters mRNA portfolio with LNP-alternative reagent

Polyplus has launched an in vivo-jetRNA transfection reagent, which uses a preformed liposome to support and expand its messenger RNA (mRNA) portfolio. Polyplus, a French biotech firm focused on providing biologic and cell and gene therapy research and production, says its in vivo-jetRNA transfection reagent is efficient, stable, and offers a safe delivery system alternative to lipid nano-particle (LNP) delivery. “Non-viral mRNA delivery methods have already proven their efficiency in vaccination through antigen presenting cell modification and in anti-cancer therapy…