GMP Manufacturing

Commercial-Ready Biologics Manufacturing

GMP Manufacturing

Commercial-Ready Biologics Manufacturing

Bionova’s state-of-the-art, commercial-ready GMP biologics manufacturing facility opened in October 2021 and will complete its first clinical supply run by year-end 2021.  With the help of industry-leading construction, design/engineering firms, and critical equipment partners,  our experienced GMP team created a world-class facility that is second to none. Bionova is now energized to deliver turnkey biologics development and production services from “DNA to bulk drug substance.”

GMP Facility Highlights

  • 1000L Growing to 4000L: The facility will initially house one 1000L fully single-use cell culture train with a 2000L train to be added in Q3/2022, expanding to two 2000L trains as demand ramps up.
  • Cell culture trains utilize Cytiva’s (formerly GE Life Sciences) XDR single-use bioreactors and FlexFactory™ Single-use Bioprocess Platform for rapid deployment and accelerated production with flexible, scalable processes.
  • Flexibility by design: facility can handle range of scales and process modes (fed-batch and perfusion) so we can best fit your product and process requirements.
  • Facility was designed with uni-directional material and personnel flow and air handling compliant with global regulatory requirements for producing commercial products.
  • On-site WFI (water for injection) generation is integrated in facility.
  • Customer audits currently underway
  • Production slot reservations are currently available for 2022.
View Time Lapse Construction Video

Designed by Pros for Pros

In addition to stainless steel, plastic, masonry and glass, experience is the most important ingredient in Bionova’s new GMP biologics manufacturing facility. Our operations and quality leadership team has extensive experience designing and operating GMP facilities, including commercial facilities at top-tier multinational CDMOs. We selected industry leaders DGA and Dome as design and construction partners because of their deep experience with biopharmaceutical facilities. We’ve designed this facility so we can operate it with the highest levels of efficiency, quality and regulatory compliance.

Preparing for Production

While the engineering and construction crews prepared the infrastructure, our Quality and Operations functions hired and trained staff and prepared Quality Systems, procedures, batch records and more to ensure GMP-readiness for production on day 1. QC testing is ready to support raw material release and our current QC testing service capabilities will soon be employed for our own GMP operations.

Driven by Client Demand

For years, clients have been asking Bionova to add GMP manufacturing capability. Based on our performance in Cell Line Development, GLP material production, process development, process characterization, analytical and other services, clients have come to rely on the strong partnerships they’ve developed with our team. After a great experience with us on a development project, they’ve had to turn elsewhere for GMP production.

We’re happy we can now offer clinical production handled by the same trusted team that has been doing such a great job in other aspects of client development programs. As an indicator of the trust clients place in the Bionova team, we have already signed multiple clinical supply agreements for the new facility.

Bionova would love to hear from you.

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