The UK’s Vaccines Manufacturing & Innovation Centre (VMIC) announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the second of two GMP COVID-19 vaccine manufacturing suites located at Oxford Biomedica's...
German life science company Sartorius will merge Slovenian purification specialist BIA Separations with Sartorius Stedim Biotech, in a deal worth €360m ($423m).
Fujifilm Irvine Scientific has become the exclusive, worldwide distributor of cellnest, a recombinant peptide attachment substrate that is said to provide optimal adhesion and proliferation of stem cells in chemically defined, animal component-free conditions.
Symbiosis Pharmaceutical Services reported a successful audit outcome by the UK government regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) for its Scottish production site.
Catalent recently announced that it is investing US$130m in an expansion project at its viral vector manufacturing facility located in Harmans, Maryland, with five new manufacturing suites set to respond to a growing customer pipeline and market demand.
Viral vector production capacity has become increasingly constrained in recent years due to increases in the therapies in development, the dosages given and the patient populations targeted. COVID-19 is exacerbating the situation.
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.
