Recognizing the industry-wide need to improve adeno-associated virus (AAV) vector manufacturing, Applied Genetic Technologies Corporation (AGTC) has adopted changes intended to increase yield and purity.
Naturally occurring viral vectors of human liver origin may be more effective than vectors grown in cultured lab conditions for liver gene therapy, according to a study published in Science Translational Medicine this month.
BioNTech will acquire Novartis’ GMP certified manufacturing facility in Marburg, Germany: with the site set to become one of the largest mRNA manufacturing plants in Europe.
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.
