Therapeutic Class Archives - Page 13 of 53 - BioProcess InternationalBioProcess International

Cell therapy process control requires a rethink, says expert

Autologous cell therapy production is a challenge and control strategies developed for protein drugs may not work, says an expert. The biopharmaceutical industry has been making therapeutic proteins for forty years. The unit operations and methods are well established and effective. Firms know how to control production to ensure the finished medicine is of appropriate quality. Industry has less experience making therapies from cells harvested from patients and this is a problem according to Rachel Yost, senior process engineer at…

BioLife invests in viral vector and freeze media tech firms

by Dan Stanton

BioLife Solutions has made investments in iVexSol and PanTHERA CryoSolutions, increasing its scope in the cell and gene therapy space. Life science tools firm BioLife Solutions and its partner Casdin Capital have invested a total of $4 million in iVexSol, as part of a $15.2 million Series A financing round, and $2 million in PanTHERA CryoSolution. iVexSol is a Massachusetts firm focused on developing its lentiviral vector (LVV) manufacturing technology platform. The startup claims the platform can produce LVVs at…

Bayer launches CGT unit on back of Bluerock and AskBio acquisitions

by Dan Stanton

Having closed its $2 billion acquisition of Asklepios BioPharmaceutical (AskBio), Bayer has established a cell and gene therapy platform. The Cell and Gene Therapy (C&GT) Platform within Bayer’s Pharmaceuticals division aims to bring various acquisitions, capabilities, and assets together. According to the firm, the unit “will provide an innovation ecosystem within which the different participating partners, whether they be independent companies or strategic collaborators, can operate most effectively. They keep and further develop their passion and biotech spirit, scientific leadership…

Moderna working 24/7 on COVID-19 vaccine manufacture and supply

by Gareth Macdonald

Moderna is confident its supply and distribution chains are robust enough to support COVID-19 vaccine scale up and roll out. The vaccine – mRNA-1273 – consists of mRNA coding for the SARS-CoV-2 spike protein inside a lipid nanoparticle. It is seen, along with jabs being developed Pfizer and AstraZeneca, as one of the best hopes for combatting the pandemic. So when clinical trial data released in November showed mRNA-1273 was 94.1% effective at protecting people from SARS-CoV-2, the news was…

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

by Ben Hargreaves

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

by Gareth Macdonald

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

by Gareth Macdonald

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

by Ben Hargreaves

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

by Gareth Macdonald

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

by Gareth Macdonald

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.…