DiNAQOR announced today the launch of DiNAQOR DiNAMIQS, a biomanufacturing subsidiary, that will accelerate development timelines and reduce costs and risk for genetic medicine companies bringing new treatments to market.
DiNAQOR DiNAMIQS is based in the company’s state-of-the-art, 1,200-square-meter (13,000 square feet) manufacturing facility in Bio-Technopark Schlieren-Zürich, the leading center for biotechnology companies in Central Europe. DiNAQOR’s Chief Technology Officer, Eduard Ayuso, will serve as the CEO of DiNAQOR DiNAMIQS.
“We look forward to partnering with the world’s leading gene therapy companies,” said Johannes Holzmeister, M.D., Chairman and CEO of DiNAQOR. “There are always challenges in the development process, and DiNAQOR DiNAMIQS is ideally suited to meet and overcome them. Manufacturing viral vectors at meaningful bioreactor scale and using GMP-compatible processes for preclinical studies will improve quality and safety while accelerating development timelines for genetic medicines.”
DiNAQOR DiNAMIQS provides a comprehensive range of manufacturing services, process development, quality control and analytics solutions to support and accelerate gene therapy projects.
The DiNAMIQS platform employs innovative upstream and downstream processes and provides high-quality recombinant adeno-associated viral (AAV) vector manufacturing suitable for both in vitro and in vivo R&D applications up to 50L scale. Aligned with GMP regulations, the manufacturing protocol provides researchers with high quality vectors and minimal changes as projects progress toward clinical applications. DiNAMIQS is currently building a state-of-the-art GMP-compliant 2,400-square-meter (26,000 square feet) facility that can produce viral vectors at 500L scale.
DiNAQOR DiNAMIQS is also pioneering customizable, GMP-compatible process development that accelerates research and development efforts and is guided by a diagnostic procedure to determine relevant bioprocessing solutions.
DiNAMIQS’ process development expertise includes 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.
Genetic medicine companies partnering with DiNAQOR DiNAMIQS will also use analytics that yield critical insights on viral vector potency, identity, and purity. DiNAMIQS in-house capabilities include digital PCR-based methods for titer quantification, ELISA, purity analyses, TCID50 infectivity assays and testing for bacterial endotoxins.
“Our state-of-the-art facility and stellar viral vector manufacturing team are prepared to help gene therapy developers bring their therapies efficiently to the clinic. I intend to bring my learnings from 20 years’ experience in the field to our partners and provide them with high quality vectors.
DiNAMIQS will shorten the time to market by closing the gaps between research grade vector supply, process development and GMP manufacturing,” said Eduard Ayuso, CEO of DiNAQOR DiNAMIQS.
“Additionally, many promising gene therapy programs slow down when the costs associated with scaling up their manufacturing begin to mount. Our biomanufacturing expertise will enable these projects to move forward in a cost-effective way — and do so quickly.”