Bluebird Bio and Celgene Corporation are collaborating to make a CAR T-cell therapy for patients with relapsed and refractory multiple myeloma in the US.
The US Patent and Trademark Office has granted a notice of allowance for ‘shelf life’ timer technology used to protect time-sensitive biologic materials in transit.
‘Splinter-like’ nanostructures have been developed by researchers in the US to deliver biomolecules straight into patient cells for immune-oncology and gene therapies.
A gene-inserting technology that effectively implants large molecules into cells could help modify T-cells from a patient’s immune system, says researcher.
Draper has designed a microfluidic transduction device (MTD) it claims will help CAR T-cell therapy developers lower costs, up efficiency – and potentially bring manufacturing to the patient’s bedside.
A newly approved patent will allow CEL-SCI to explore using cellular delivery to prevent and treat infectious diseases using its LEAPS technology, the firm says.
Lonza will combine its cell and gene therapy capabilities through four centres of excellence worldwide, following a number of investments in the space.
Lonza has inked a biologics deal with Denali to make neurodegenerative disease therapies, offering the Californian firm opportunity to have production “on their back doorstep.”
Adaptimmune Therapeutics has manufactured the first SPEAR-T cells for a patient at its Navy Yard facility, which will be the primary site for its future manufacturing requirements.
Synpromics will make synthetic promotors for a collaboration with UCL Great Ormond Street Institute of Child Health to develop gene therapies for blood-based disorders.
The need for CDMOs with commercial gene therapy capacity is growing says Fujilfilm Diosynth Biotechnologies, which has opened an 80,000 square-foot plant in Texas.
Cellular Biomedicine Group Inc (CBMG) has selected GE Healthcare’s FlexFactory technology for its CAR-T therapy production facility in Shanghai, China.
CAR T-cell understanding must come before the process design if such therapies are ever going to be accessible to a larger patient population, says Autolus.
Venture capital company Dynamk Capital has invested in FloDesign Sonics citing its acoustic wave separation technology’s application in the growing CAR T cell sector.
Takeda has said it will review the manufacturing of Alofisel (darvadstrocel) if its €520m ($620m) bid for off-the-shelf stem cell developer TiGenix is successful.
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.