Spark Therapeutics has received US approval for Luxturna (voretigene neparvovec-rzyl), its one-time gene therapy treatment for an inherited form of vision loss.
Yposkesi will make lentiviral vectors for Orchard Therapeutics’ gene therapies – indicated to treat primary immunodeficiencies – at its facility near Paris, France.
Harpoon Therapeutics has selected CMC Biologics to develop and manufacture three molecules for cancer treatments at the CDMO’s facilities in California and Washington State, US.
CAR T developers must be involved throughout the entire supply chain says Kite Pharma, which depends on accreditation and training programmes across its network of Yescarta administration clinics.
Fibrocell Science will make its gene therapy candidate FCX-007 from a facility in Pennsylvania previously dedicated to making its autologous personalised cosmetic Laviv (azficel-T).
By InVitria launches xeno-free service within $5.2bn media market
Xeno-free media will continue to increase its share of the estimated 30m litre mammalian cell culture market says InVitria, which has launched a new formulation service.
Heavy investment in quality control, quality assurance and dedicated equipment is likely to keep CAR T-cell manufacturing in-house, says Juno Therapeutics.
Gilead says it is looking to make as many as 90 academic centres available to administer CAR-T Yescarta (axicabtagene ciloleucel) following its approval in the US.
GSK will look to optimise its induced pluripotent stem cell (iPSC) differentiation processes through collaboration with high throughput tech firm Plasticell.
Batavia Biosciences will expand a Dutch production facility and build a viral vector plant in the US to cater for demand for its bioprocessing services.
Shibuya and Promethera Biosciences are establishing a manufacturing platform for cell-derived liver therapies at the latter’s facility in Gosselies, Belgium.
Kiadis Pharma says it is looking at expanding production of its blood cancer cell therapy candidate ATIR101 after receiving US FDA breakthrough designation.
After receiving approval Kymriah, Novartis must prove it can handle the supply chain complexities of manufacturing high-value and time-sensitive CAR-T cell therapies, says logistics firm TrakCel.
Gilead says it is committed to driving down costs of CAR-T manufacturing after agreeing to buy late-stage cell and gene therapy firm KitePharma for $11.9bn.
Oxford BioMedica saw its share price jump 21% after the US FDA approved Kymriah, the gene modified cell therapy made with the firm’s lentiviral vectors.
CSL Behring will launch itself into the stem cell gene therapy through the acquisition of Calimmune, adding a preclinical candidate and two manufacturing efficiency technologies.
The US FDA has warned a Florida-based clinic and seized vials of a smallpox vaccine in California used to create an unapproved product in a crackdown against "unscrupulous" stem cell firms.
Kite Pharma has submitted the first CAR-T candidate axicabtagene ciloleucel to the EMA for review and says it is evaluating manufacturing options in Europe.
Lonza will install four 2,000L single-use bioreactors at its Singapore facility to cater for growing demand for small to mid-volume biologics production.
Takeda says it is assessing manufacturing options ahead of potential European approval later this year of the Crohn’s disease stem cell therapy licensed from TiGenix.
Cell Medica says it will work with the Cell and Gene Therapy Catapult to assess automation and processing technologies involved in scaling-up the acquired cancer candidate.
Hitachi Group subsidiary PCT Cell Therapy Services will provide clinical manufacturing services for Orchard’s autologous gene therapy for the treatment of adenosine deaminase deficiency.
Xeno-free and cGMP-manufactured media are highly desired by cell therapy developers, says Irvine Scientific as it launches a medium for hematopoietic stem and progenitor cells (HSPCs).
Scottish synthetic biology firm Synpromics has received £5.2M ($6.6M) to enhance its synthetic promoter design technology used in gene therapy development.
