GMP manufacturing platforms to help our clients bridge their ATMPs development to the clinic. Established centers of excellence in ATMP technologies to accelerate GMP-readiness, manufacturing and QC release.
uBriGene offers integrated CDMO services to support cell and gene therapy product developers including tech transfer, process and analytical development, scale-up, GMP-readiness, and regulatory support.
GMP CAR-T and CAR-NK, iPSC, and MSC therapy workflows with access to qualified raw materials and gene-modification platforms (lentivirus, RNA) that meet the highest regulatory standards for cell therapy production.
View GMP Cell Therapy ServicesGMP lentivirus manufacturing platform with access to qualified raw materials that meets the highest regulatory standards for vector production.
Robust GMP CRISPR guide RNA in vitro transcription platform process, more scalable and cost-effective.
GMP LNP-mRNA, circRNA, and saRNA platform manufacturing to support RNA therapeutics and vaccine development.
GMP AAV manufacturing platform with access to qualified raw materials that meets the highest regulatory standards for vector production.
View GMP AAV ServicesRobust plasmid manufacturing platform with extensive experience releasing GMP plasmids that meet the highest regulatory standards.
View GMP Plasmid ServicesGMP manufacturing and characterization of eukaryotic and prokaryotic cell banks.
View GMP Cell Banking ServicesOncolytic virus manufacturing platform services with experience in producing vaccinia virus, adenovirus, and herpesvirus oncolytic vectors.
Semi-automated and automated fill/finish capabilities to support final formulation in a variety of formats.
Experienced regulatory team to support agency filings that meet the highest regulatory standards.
Centers of Excellence for manufacturing and testing
GMP batches successfully delivered
INDs filed and accepted with FDA, EMA, and CDE
Centers of Excellence for manufacturing and testing
GMP batches successfully delivered
INDs filed and accepted with FDA, EMA, and CDE
