Therapeutic Class

Rooster Bio and Sartorius team to streamline hMSC production

Cell bank firm Rooster Bio has teamed with Sartorius to find ways of scaling-up production of stem cell-based regenerative therapies. The collaboration will combine Rooster’s human mesenchymal stem/stromal cell (hMSC) working cell banks and media systems with Sartorius’ single-use manufacturing tech, process control software and analysis tools. The aim is to provide “robust, streamlined, end-to-end platform technologies and protocols that can be implemented for rapid scale up of manufacturing processes, allowing product developers to significantly speed up their development timelines,”…

Biocon: COVID dampens $1bn biosimilar sales target

COVID-19 has caused regulatory inspection delays, operational slowdowns and lower consumption, diminishing Biocon’s aspiration of reaching $1 billion in annual biosimilar revenues. On paper, Biocon’s third quarter FY21 was positive. Sales grew 7% year-on-year to INR 1,879 crore ($258 million), with an 11% growth in biosimilars contributing INR 769 crore to the total. Quarter-over-quarter, biosimilar sales grew 14%, and Biocon’s presence in marketed biosimilars further grew with a number of approvals across various jurisdictions, including EMA recommendation for its insulin…

Cognate pushes on with global expansion project despite COVID

Cognate plans to increase capacity in Europe four-fold and to double existing capacity at its US site. This time last year, Cognate Bioservices completed the acquisition of Cobra Biologics, adding its plasmid and viral vector manufacturing capabilities to its own cell therapy services. Cognate began this year with another announcement, it would be adding to its subsidiary’s manufacturing capacity through an investment in Europe, alongside bolstering its existing facilities in the US. The European expansion will see Cobra quadruple capacity…

Joint venture promises to reduce manufacturing cost of cell and gene

Three organizations have created ScaleReady to provide a ‘cost-effective’ cell and gene production platform. The joint venture combines the capabilities of Bio-Techne, Fresenius Kabi, and Wilson Wolf, which each take an equal share in the newly created business. ScaleReady will offer technologies for cell culture, cell activation, gene editing and cell processing developed separately by these companies. The joint venture business itself will provide the sales, marketing, and application support for the cell and gene therapy manufacturing platform created by…

Double Dutch: Cristal and Intravacc team on vaccine tech

The partnership looks to develop vaccines using Intravacc’s outer membrane vesicles (OMV) tech and Cristal Therapeutic’s copper-free click chemistry reagent with an initial target being COVID-19. The two companies will work together to develop novel vaccine programs with initial work during the evaluation period taking place at Cristal’s facility, followed by the further work conducted at Intravacc’s facility, both in the Netherlands. Financial details of the collaboration have not been divulged. Initially, the partnership is targeting a vaccine against COVID-19.…

Sanofi: ‘Vaccine heritage puts us in good stead to play in gene therapy space’

Sanofi says it is looking to resolve the “patchy” accomplishments in the gene therapy space through a new specialized unit that will leverage technologies from its vaccine division. Sanofi has dabbled in the cell and gene therapy over the past decade but is yet to make its mark. Speaking at the JP Morgan Healthcare Conference this week, CEO Paul Hudson highlighted the importance of the sector going forward but admitted industry’s success in the sector has “been patchy.” He told…

Fujifilm invests in third viral vector plant citing ‘surging’ demand

Fujifilm says surge in demand for viral vectors prompted decision to invest in third development and production plant. Fujifilm announced plans to invest $40 million to set up the new plant in in Watertown, Massachusetts last week. The Japanese conglomerate’s contract services unit – Fujifilm Diosynth Biotechnologies – will run the facility when it comes online. In a press statement the CDMO’s CEO Martin Meeson said, “We are strategically establishing this facility in the greater-Boston area where there is a…

Singapore sets sights on soaring stem cell demand

Singapore’s A*star wants to use micro-carrier tech to capture a share of the global stem cell manufacturing market. Demand for stem cells has increased markedly in recent years, creating a significant opportunity for those willing to innovate to help industry address its manufacturing challenges according to Steve Oh from A*star. “In a bid to do that, the Singapore government invested $80 million in three programmes to manufacture living cells as medicines,” Oh told delegates at the Cell and Gene Therapy…

French biotech sets up exosome plant to deliver proteins and vaccines

Ciloa says its exosomes can ‘deliver’ large molecules and viral proteins to specific organs and is setting up a clinical plant in Montpellier, France. The €1 million ($1.2 million) investment will be used to create an exosome production unit at Ciloa’s site in Montpellier. The facility will be a technological demonstrator that will be the prototype for larger projects of production of customized exosomes, capable of producing around 1,000 doses to support early clinical trials, the firm told us. Exosomes…

Quality cell banks de-risk regenerative medicine development, says consultant

Minimizing variability in cells used to make regenerative medicines is vital but challenging according to an expert, who says a quality cell bank is key. Cell and gene therapies have the potential to revolutionize medicine and allow physicians cure previously untreatable diseases. But developing a process that produces a stable, consistent product is a technical challenge. A major challenge is that the starting materials – the cells from which the medicines are produced – need to be carefully handled says…