The importance of reagent quality control, especially endotoxin testing, during CGT development and the selection of reagents and suppliers to ensure safety.
Garrett Perry, Technical Services Specialists at Teknova09.14.21
Spray drying is an established particle engineering technology that offers several advantages over other methods used for improving API bioavailability.
Bikash Chatterjee of Pharmatech Associates discusses the reshoring trend, technologies and advances that could help deliver more manufacturing back to the U.S.
Market estimated to grow at CAGR of 20% from 2021 to 2028 due to an exponential rise in clinical pipeline along with rising number of regulatory approvals.
Microbiological testing is a critical component to ensuring the quality and safety of pharmaceutical products. Explore more in this webinar on August 26.
Will leverage integrated services from Selexis and KBI as part of Immatics’ development of TCR Bispecifics, designed to detect, target and attack tumor cells.
LION-101 is a recombinant adeno-associated virus based vector being developed as a one-time intravenous infusion for Limb-Girdle Muscular Dystrophy Type 2I/R9.
Supports Mirus’ expansion of GMP production of its flagship product TransIT VirusGEN for large scale manufacturing of AAV and LV viral vectors for gene therapy.
Will integrate Cryoport's Cryoportal Logistics Management Platform and LabConnect's SampleGISTICS platform to provide Triumvira with advanced logistics support.
Collaboration investigates enhanced manufacturing of AAV and lentiviral vectors to improve quality and productivity for gene therapy and vaccine developers.
Aims to provide improved product tracking, scheduling and live monitoring of the manufacturing status across the entire CGT supply chain from vein to vein.
Vetter’s decades of experience as a contract manufacturer providing fill & finish for injectable drugs helps deliver results for both large and small companies.
Dendritic cell vaccine production capacity for personalized immune therapies increases from about 4 - 6 patients per month to about 40 - 45 patients per month.
Adds Project Farma's unique expertise to Precision's suite of end-to-end cell and gene therapy capabilities to support development and commercialization.
Will accelerate the commercialization of Koligo’s KYSLECEL, a personalized islet cell therapy available in the U.S. for chronic and recurrent acute pancreatitis
Newark, NJ process development and clinical manufacturing facility for cell and gene therapies becomes first of its kind located on a U.S. university campus.
A fully functional 20,000 sq. ft. GMP facility featuring 10 ISO Class 7/Grade B clean rooms to enable production of cells and viral vectors for Phase I and II clinical trials.
CDMO’s capacity to produce AAV materials at large-scale will support Genethon and Sarepta’s project to take micro-dystrophin to clinical trials this year.
Mike Grippo will serve as senior vice president, Strategy and Corporate Development, and Julien Meissonnier as vice president and chief scientific officer
As companies move their cell and gene therapies through the development process, supporting larger Phase III trials and commercial launches will be a challenge
Ryan Carpentier, Executive Director of Business Development, Cryoport09.23.19
Cytegrity™ is a stable producer cell line developed by St. Jude Children’s Research Hospital for the treatment of X-linked severe combined immunodeficiency
Andrew Kolbert of Avomeen discusses FDA oversight of E&L testing, complications that arise, and the expertise needed to keep up with changing quality standards
Paragon Gene Therapy, part of Catalent Biologics, will provide materials for preclinical and Phase 1/2 trials for IVERIC’s gene therapy product candidates
Voyager gains worldwide rights to VY-HTT01 Huntington’s disease program and ex-U.S. rights to VY-FXN01 Friedreich’s ataxia program for $10 million upfront