Bionova Scientific, a contract development and manufacturing organization (CDMO), is expanding its manufacturing capabilities by installing a third FlexFactory manufacturing platform from Cytiva to enter the rapidly growing advanced therapy market. The strategic move allows the company to meet surging demand for advanced therapies while maintaining its established monoclonal antibody (mAb) business operations.
Strategic Partnership for Genomic Medicine Manufacturing
The collaboration extends beyond equipment installation, with Bionova leveraging Cytiva's Fast Trak process development services to accelerate its entry into genomic medicines manufacturing. Dr. Fabio Fonseca, Senior Director of pDNA Process Development at Bionova Scientific, emphasized the comprehensive nature of the partnership: "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."
FlexFactory Platform Advantages
The FlexFactory platform for advanced therapies delivers multiple operational benefits designed to enhance manufacturing efficiency and compliance. According to Cytiva, the platform reduces business risks, increases operational speed, enables faster product ramp-up, and enhances manufacturing flexibility. The system incorporates built-in compliance features and robust quality controls to improve regulatory adherence and minimize production issues.
Ludovic Brellier, President of Hardware Solutions at Cytiva, highlighted the company's process expertise: "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."
Facility Expansion and Timeline
Bionova's expansion includes a new facility in The Woodlands, Texas, which celebrated its grand opening on May 29, 2025. The new FlexFactory platform is scheduled for delivery in Q3 2025, positioning the company to begin advanced therapy manufacturing operations in the latter half of the year.
The modular setup of the FlexFactory platform allows for rapid adaptation to market shifts, providing Bionova with the operational agility needed to respond to evolving demands in the advanced therapy sector. Cytiva's Fast Trak process development services will support Bionova in accelerating molecule development through clinical phases, from early development to commercial manufacturing scale.
