Bionova Scientific, a biologics CDMO with extensive protein production, cell line development, process development and analytical expertise, has 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 biologics manufacturing facility. Commissioning of the facility is scheduled for Q3 2021.
 
A Major Milestone
 
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 additional clients for GMP manufacturing programs and is scheduling for production slots in 2021 and beyond.