The companies are collaborating to apply ShapeTX’s AAVid capsid discovery platform and transgene engineering technology in addition to Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for eye diseases.
Despite the successes that have already been achieved with emerging therapy development and manufacturing, companies are still facing numerous challenges.
The agreement states that Orbit will implement its bead-based peptide display engine to discover peptide leads specific to targets related to specific tumors.
In this episode of Drug Digest, industry experts discuss aseptic processing and manufacturing, including what the future holds in this area and the barriers involved with automated aseptic processing practices.
Rentschler Biopharma, CGT Catapult, and Refeyn aim to use automated and digital technologies to improve AAV manufacturing for gene therapies.
The launch of Alpha Teknova’s new manufacturing facility in Hollister, Calif., increases its capacity for custom reagents for life sciences applications.
The site was acquired by AGC Biologics in July 2020, and the Milan location is the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies.
The initial collaboration between the two companies began in 2017 with an extension announced in 2021.
In this episode of Drug Digest, editors discuss what happens in the manufacturing space from a CDMO and a cell/gene therapy perspective.
The bioreactors can integrate with Emerson’s DeltaV PK Controller in addition to S-Series and M-Series controllers.
Burgeoning CGT modalities bring promise and challenges.
mRNA may be a modality whose chief advances are yet to come.
FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.
Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.
The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.
The prestigious award, worth €20,000 (US$22,000), goes to Maurice Michel of the Science for Life Laboratory at Karolinska Institutet, Stockholm, Sweden.
The new headquarters located in Columbus, Ohio, more than triples Andelyn Biosciences’ footprint to meet growing demand for CGT services.
The project is being coordinated by the recently formed not-for-profit CCRM Nordic AB and gathers engaged stakeholders to move the initiative forward.
The current lack of standardization within the industry can be attributed to the recent rapid growth of the cell therapy market and the associated drive to improve the efficiency and cost-effectiveness of production.
The pin-point system is completely modular, allowing for different components to be selected for optimal performance specific to the gene targets.
CATTI has launched an in-person training site at the University of Guelph in Ontario, Canada, for training personnel in cell and gene therapy manufacturing.
Avirmax’s new gene therapy facility in Hayward, Calif., will specialize in AAV gene therapy research and development.
New therapeutic opportunities are offering significant promise for the bio/pharma industry and patients.
CDMO Exothera and biotech company Remedium are joining forces to scale up the manufacturing process for Remedium’s lead gene therapy candidate for treating osteoarthritis.
The combined solutions are currently available on the market.
