Bikash Chatterjee of Pharmatech Associates discusses the reshoring trend, technologies and advances that could help deliver more manufacturing back to the U.S.
Veklury (remdesivir) with sales of $829 million offsets loss of exclusivity of Truvada and Atripla in the U.S. with sales down 72% and 42%, respectively.
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.
Strengthens cell therapy pipeline with individualized solid tumor Neoantigen TCR cell therapy R&D program and adds manufacturing footprint in North America.
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.
ProBioGen to provide cell line development, process development and GMP manufacturing at 1000 L bioreactor scale of Asher's lead immuno-oncology candidate.
Aims to provide improved product tracking, scheduling and live monitoring of the manufacturing status across the entire CGT supply chain from vein to vein.
More robust solutions for single-use cold-chain containers made with polytetrafluoroethylene fluoropolymers may be less susceptible to failure and breakage.
Recognizes manufacturing facility and processes are in compliance with GMP requirements and readiness to provide commercial aseptic fill/finish services.
To show the impact to autologous and allogeneic cell therapies by integrating novel transfection technology with other steps in the manufacturing process.
Will increase 7000L drug substance capacity (MFG21) and drug product capacity (DP11) for liquid and lyophilization within its global manufacturing network.
Dendritic cell vaccine production capacity for personalized immune therapies increases from about 4 - 6 patients per month to about 40 - 45 patients per month.
Overcoming challenges of implementation and achieving increased volume, reduced timelines, decreased footprint, lower cost of goods, and increased flexibility.
Priyanka Gupta, Head of Market Entry Strategy for Protein Based Therapeutics, Sartorius03.09.21
Will focus on clinical and commercial clients, especially as Cognate expands its business with allogeneic and autologous on-demand cell and gene therapies.
Adds Project Farma's unique expertise to Precision's suite of end-to-end cell and gene therapy capabilities to support development and commercialization.
As a partner to the U.S. Government, GRAM's newest facility was designed to increase large-scale fill and finish capacity with room to expand as demand grows.