Partnership with Cytiva includes Fast Trak process development to accelerate clinical readiness and ensure regulatory compliance for advanced therapies
- Third Cytiva FlexFactory manufacturing platform will help the CDMO meet the rising demand for genomic medicines
- Cytiva’s Fast Trak process development services will accelerate Bionova’s production processes while ensuring compliance with stringent regulatory standards
Bionova Scientific, a contract development and manufacturing organization (CDMO), is entering the advanced therapy manufacturing space. The company is installing its third FlexFactory manufacturing platform from Cytiva, a Danaher company and a leader in the life sciences industry, to help meet the surging demand for advanced therapies, while maintaining their core monoclonal antibody (mAb) business. Bionova will also use Cytiva’s Fast Trak process development services to help advance their entry into genomic medicines.
Fabio Fonseca, Ph.D. Senior Director, pDNA Process Development, Bionova Scientific, says: “Using Cytiva’s end-to-end solutions, we’ll have an exceptional platform to support the manufacture of genomic medicines. Together with our team and technology stack, we are well positioned to deliver plasmid DNA with speed, quality and patient safety.”
Ludovic Brellier, President of Hardware Solutions, Cytiva, says: “Our true value lies in our deep process expertise in accelerating our customer’s process development through to commercial manufacturing. Having the flexibility and support to scale while meeting strict regulatory compliance will help Bionova develop a competitive edge in a growing market.”
The FlexFactory platform for advanced therapies offers substantial benefits that reduce business risks, increase operational speed, faster product ramp-up, and enhance flexibility. Its built-in compliance features and robust quality controls helps improve regulatory adherence and minimize production issues, while its modular setup allows rapid adaptation to market shifts. Cytiva’s Fast Trak process development services will help Bionova accelerate their molecule through clinical development.
Bionova’s new facility in The Woodlands, Texas celebrated its grand opening on May 29, 2025, with the new FlexFactory slated for delivery in Q3 2025.
