Gene therapy developer, CombiGene, and CDMO, Cobra Biologics, have signed off on a deal to secure Good Manufacturing Practice (GMP) production of two essential plasmids needed for the manufacture of CombiGene's gene therapy, CG01.
Thermo Fisher Scientific has opened a new bioprocessing collaboration center (BCC) adjacent to its biologics manufacturing facility in St Louis, Missouri.
Cytiva is to invest US$500m over the next five years to raise manufacturing capacity, hiring nearly 1,000 personnel in Austria, China, Singapore, Sweden, and the US, and bringing on new manufacturing lines, 24/7 shift patterns, and increased automation.
An FDA regulatory request to Sarepta could delay the timeline for approval of its Duchenne muscular dystrophy (DMD) gene therapy if it results in a deferral of the start of a planned Phase 3 study for SRP-9001.
Lonza reports that the first cancer patient has been dosed at Sheba Medical Center in Israel with autologous CAR-T therapy manufactured using the Swiss company’s Cocoon Platform.
AskBio, which develops adeno-associated virus (AAV) gene therapies for genetic disorders, has won an R&D grant valued at £2m (around US$2.7m) from Scottish Enterprise.
Zolgensma has received a recommendation for approval despite running into problems recently, including manufacturing questions and data integrity issues.
Immunogenesis is tapping into ProBioGen’s manufacturing capabilities for its immuno-oncology lead candidate, as the potential treatment enters the clinic.
Designed specifically for AAVs production to support gene therapies, a medium launched by Lonza is expected to accelerate cell growth while saving developers time and costs.
