While the engineering and construction crews prepare the infrastructure, our Quality and Operations functions are hiring and training staff and preparing Quality Systems, procedures, batch records and more to ensure GMP-readiness for production on day 1. QC testing is being established in advance to support raw material release and our current QC testing service capabilities will soon be employed for our own GMP operations.
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. A long-time client has already signed a clinical supply agreement with us, a strong indicator of the trust they place in the Bionova team.