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Bionova Scientific secures first client commitment for GMP manufacturing
FREMONT, CA, November 16, 2020 – Bionova Scientific, a biologics CDMO with extensive protein production, cell line development, process development and analytical expertise, today announced it had secured its first client commitment for GMP clinical supply. The client, whose name was not disclosed, has worked closely with Bionova for several years on process development (upstream and downstream), formulation studies, analytical development, GLP protein production for preclinical development and other services to support its pipeline. The new agreement covers technology transfer, scale-up, tox supply and 1000 liter clinical bulk drug substance production.
In July 2020, Bionova announced that it had initiated construction of its new state-of-the-art biologics manufacturing facility. Commissioning of the facility is scheduled for Q3 2021.
Bionova Chief Executive Officer, Amy Kong, commented, “This is a major milestone for Bionova. We are still several months from completion of our GMP facility, so this commitment from a long-time client represents a deep trust in our team and a strong endorsement of the work we have completed on their behalf. They ultimately decided that no other CDMO offered the expertise needed to handle this program.”
Bruce Frazier, Bionova VP of Business Development, added, “We are grateful for the confidence this client has shown in Bionova. Based on their experience working with us on several challenging technical projects, they decided that we are the best team to handle scale-up and production of a demanding clinical candidate. They are familiar with our plans for the facility and are confident that the plant and our people will deliver for them.”
Frazier added, “We are so proud of the work our operations, quality and technical teams did to demonstrate Bionova’s readiness to deliver on this critical program. It’s never easy securing the first commitment, but our team went above and beyond to make it clear that we are a CDMO partner that can be counted on.”
Bionova is in active discussion with addition clients for GMP manufacturing programs and is scheduling for production slots in 2021 and beyond.
ABOUT BIONOVA SCIENTIFIC
Founded in 2014, Bionova offers world-class biologics CDMO services built on a foundation of strong process development and analytical science with a staff who brings decades of experience in late stage and commercial launch projects. We firmly believe that a robust, well-understood process and well-characterized molecule are critical cornerstones of your molecule’s success. Our upstream PD group, with more than 50 benchtop bioreactors, offers a breadth and depth of capability typically found at only the largest service companies. Bionova takes an expansive view at solving client process problems. In 2019, Bionova acquired a new 57,000 sq. ft. facility in Fremont, California where we are currently expanding our development lab capabilities with new equipment and additional staff, and where we will launch our new cGMP biologics manufacturing operation in 2021.
ABOUT THE BIONOVA GMP BIOLOGICS MANUFACTURING CENTER
The 36,000 sq. ft. facility will utilize single-use technologies for all core unit operations and is designed to accommodate two 2000L mammalian cell culture trains, capable of producing clinical and commercial bulk drug substance. Located within Bionova’s 57,000 sq. ft. headquarters, the plant is optimized for multi-product manufacturing of monoclonal antibodies and other recombinant proteins. Bionova has partnered with industry leaders DGA and Dome Construction for design and construction. In addition to the GMP facility, Bionova has added 20,000 sq. ft. of warehouse space to support operations and for future expansion.