UK government invests further in businesses manufacturing advanced therapies, opening a fund for companies working on technology to improve commercial production.
Pfizer invests half a billion dollars to expand its gene therapy manufacturing facility in North Carolina and enhance its position to compete in the booming market.
Contract packaging provider Reed-Lane adds dedicated room for vial and ampule kitting to its cold chain capabilities to limit intra-facility travel and product excursion as a means of security.
Merck enters a clinical collaboration agreement with Oncologie to evaluate the combination of investigational drug Bavituximab and Keytruda in cancer patients.
The increasing number of cell and gene therapies in clinical development is evolving the supply chain into a ‘supply cycle,’ says TrakCel CEO, with service providers being called to maintain control under pressure.
The FDA approves targeted biologic, Dupixent, for the treatment of atopic dermatitis in patients 12 to 17 years old, the first treatment of its kind for adolescents.
The global market for regenerative medicines raised $4.8bn in the first half of 2019; a slowdown compared to the same period of 2018, though the sector is poised for additional growth, says ARM CEO.
EQT VIII Fund set to acquire majority interest in plasmid DNA supplier Aldevron, announces investments to support the expansion of its production capacity.
Alleged manipulated and potentially inaccurate clinical data in the BLA for the $2.1m Zolgensma spark possibility for criminal penalties against AveXis.
New data on the genetic biomarkers impacting the development of cancer treatments has been released creating the largest publicly accessible dataset of its kind.
Lonza enters a partnership with Vineti to advance its ‘vein-to-vein’ delivery network, creating an end-to-end ordering and manufacturing process in support of cell and gene therapy development.
The summer months are traditionally slow on movements across the industry, but July saw a number of manufacturing partnership deals take place as companies look ahead to product commercialization.
AveXis and BIA Separations announce an agreement for the commercial purification process of SMA gene therapy drug Zolgensma and further gene therapy candidates.
As we have entered the summer, companies have taken to refreshing their leadership positions, including at companies such as Gilead, Alnylam, and Maze Therapeutics.
CGT Catapult reports that employment has increased substantially, and production capacity has grown by 60% in the UK cell and gene therapy manufacturing industry.
Catalent Biologics works with Novartis to develop and manufacture its SMA gene therapy treatment and provide manufacturing capacity, as the treatment enters the market.
Paragon and Passage Bio enter a collaboration agreement to develop a dedicated manufacturing suite at the former’s Maryland facility, as the latter’s gene therapy candidates enter the clinic.
The EMA looks to the future by posting its five key priorities to address in the coming five years, which includes the need to recruit expertise in ‘novel manufacturing technologies’.
The major trend so far in 2019 is the willingness to deploy capital to expand services in the cell and gene therapy sector, and we outline the five most significant deals thus far.
Aiming to boost the gene therapy development and manufacturing capabilities of Paragon, which Catalent acquired in April, the CDMO has agreed to acquire all of the gene therapy-related assets from Novavax, a late-stage vaccine developer.
Cobra and Symbiosis announce the completion of their collaboration on viral vector development and manufacturing, supported by £1.9m Innovate UK grant.
After a grant from the Bill & Melinda Gates Foundation, Univercells will adapt its low-footprint, cabinet-contained vaccine production line to create affordable measles and rubella vaccinations.
Fujifilm Diosynth has developed its ability to transition products from research to GMP, answering a big challenge as more parties look to get involved in the space, says COO.
‘We don’t want to change the way we work,’ says GE Healthcare Life Sciences CEO, as Danaher’s $21bn acquisition of the BioPharma business continues in the background.
BMS’ capture of Celgene caught much attention, due to the size and scale of the acqusition, but rival companies have taken the chance to snap up employees that have left after the deal.
GSK signs partnership deal with the University of California to advance genomic research, which sees the creation of a lab and funding for five years of research.
Vertex agrees to acquire Exonics and to expand its collaboration with CRISPR Therapeutics, which sees it invest $420m in upfront payments to develop its position in gene therapy.
