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.
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.
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.
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.
After posting revenue growth of 39%, Repligen CEO suggests this was driven by filtration and chromatography franchises, particularly customers in gene therapy.
Year-on-year, the number of trials for advanced therapeutics has doubled, meaning that the UK now represents 12% of all global clinical trials in the area.
Thermo Fisher Scientific doubles the capacity of its gene therapy and viral vector processing facility in Alachua, Florida, to provide scalability to customers.
GE Healthcare assigns Pharmadule Morimatsu to expand the offering of its ‘factory in a box’, known as KUBio, enabling the scale-up of biologics manufacture.
Solid Biosciences announces that its gene therapy for DMD has been placed under clinical hold again, after a patient experienced a serious adverse event.
The pace of development in the industry sees greater demand for a trained workforce, which is leading away from ‘classroom’ to technology-assisted working environments, says training lead at Zenith.
NIH and the Gates Foundation have set themselves the goal of bringing curative gene therapies to clinical trials in the US and Africa in the next seven to 10 years.
Novartis announces its third quarter results that show Zolgensma is outperforming sales expectations, but company notes approval in EU and Japan pushed back over manufacturing queries.
Novo Nordisk partners with bluebird on a three-year research arrangement looking to discover gene therapy candidates for the treatment of genetic diseases, including hemophilia.
