Bristol-Myers Squibb and PTC Therapeutics enter a long-term lease agreement giving the latter greater access to biologic production facility as it advances its treatments for rare genetic disorders.
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.
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.
Vaccine research is still quite ‘empirical’ and there is a long way until it is turned into a rational, predictable modality, suggests director at the Bill and Melinda Gates Foundation.
Regeneron and Sanofi’s Libtayo is granted marketing authorization by the European Commission for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma.
Avastin biosimilar from Pfizer receives approval from the FDA for the treatment of five forms of cancers, increasing market competition for the originator drug.
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.
Amgen’s biosimilars portfolio reaches a milestone after its Herceptin biosimilar, Kanjinti, developed in collaboration with Allergan, was approved by the US FDA.
As the cell and gene therapies market evolves, CDMOs and pharmaceutical companies aim to adapt to the rising demands and serve larger patient populations.
Servier to work with Yposeski for the production of lentiviral vectors, as the former works to develop allogenic CAR-T cell technology for hematological therapies.
Aldevron announces the expansion of its headquarters’ campus by half a million-square-feet, which will see annual capacity exceed $1bn of biologic products.
Fujifilm Life Science Strategic Business Office will open a site in Cambridge, Massachusetts in an aim to further link up with the surrounding pharmaceutical and biotech community.
Thermo Fisher and Scinogy partner to improve scalability and cost-effectiveness of cell and gene therapy manufacture through the addition of the former’s centrifuge.
GSK is investing in ‘significant’ capacity expansion to support production of its shingles vaccine, which has been approved in China after clinical trials demonstrated 90% efficacy.
Translational research faces new challenges – and opportunities – with the rapid growth in precision medicine and new drug modalities, as the industry looks to quickly bring new treatments to patients.
SGS’ completed the ₤8.7m expansion of its large molecule testing facility in Glasgow and made room to increase its existing biosafety service and PCR platform capabilities.
WuXi Biologics announces its latest expansion, with plans for a drug development and commercial manufacturing site with a potential bioreactor capacity of 144,000L.
Dupixent, Regeneron and Sanofi’s collaborative mAb treatment for eczema, has been approved by the European Commission for a new indication in severe asthma.
The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option.
Novartis investigates the death of an infant in a gene therapy clinical trial to determine whether it was related to the treatment but does not anticipate an impact on FDA approval.
US FDA grants orphan drug designation for Hyleukin-7, an immuno-oncology agent that boosts T cell production and functionality, for the treatment of ICL.
The expanding cell therapy market has placed new demands on supply chain services, with their shipment requirements and competition in the logistics industry rising.
I-Mab and WuXi Biologics extend their strategic partnership for biologics process development as well as clinical and commercial manufacturing to accelerate drug development in China and abroad.