Bringing Viral Vector Manufacturing and Analytics to the Global Gene Therapy Community
DiNAMIQS provides a comprehensive range of manufacturing services, process development, quality control and analytics solutions to support and accelerate your gene therapy project.
AAV manufacturing from our state-of-the-art research facility that optimizes workflow and employs innovative upstream and downstream processes. This includes high quality recombinant adeno-associated viral (AAV) vector manufacturing suitable for both in vitro and in vivo R&D applications up to 50L scale. Our manufacturing platform is based on transient transfection of HEK293 in stir tank bioreactors (2L, 4L and 50L) and chromatography purification. Aligned with GMP regulations, our manufacturing protocol will provide your research with high quality vectors and minimal changes moving forward to your clinical applications.
Process development that is customizable, GMP-compatible and enhanced to accelerate R&D timelines. Our biomanufacturing expertise for suspension based AAV ranges from biomass expansion in bioreactor, large-scale transfection, harvest and clarification, ultrafiltration/diafiltration, affinity chromatography capture, ion exchange chromatography, preparative ultracentrifugation, desalting, dynamic dialysis, formulation, sterile filtration, automation assisted fill and finish. And every process begins with a diagnostic using well-established tools to deliver relevant bioprocessing solutions.
AAV vector characterization and quality control
AAV vector characterization and quality control at every stage of production with analytics yielding critical insights on viral vector quantification, potency, identity, and purity. Our in-house capabilities include digital PCR-based methods for titer quantification, ELISA, purity analyses, TCID50 infectivity assays, testing for bacterial endotoxins and more. We offer you a full analytical service package for your gene therapy product, tailored to your needs.
- High quality recombinant adeno-associated viral (AAV) vector manufacturing suitable for both in vitro and in vivo R&D applications at bioreactor scale (2L, 4L, 50L)
- GMP-compatible process development capabilities including analytical development and assay transfer
- In-house quality control testing for R&D batch release
- Technology transfer for GMP manufacturing of viral vectors up to 50L scale