Bionova Scientific, Inc. services

Analytical Expertise and Tools to Support Biologics Development and Manufacturing. Bionova’s analytical sciences group actively engages with our internal cell line development, upstream and downstream process development, formulation development and GMP manufacturing groups to provide analytical support to all client programs.

Bionova Scientific offers rapid protein production utilizing either transient transfected CHO and HEK 293 cells or stable transfected pools or clones to enable acceleration of your proof-of-concept activities (up to gram quantities if required).

Bionova offers a comprehensive suite of upstream process development services and maintains one of the most advanced mammalian cell culture PD labs among CDMOs of any size. We are tightly integrated with our Cell Line Development group and our GMP manufacturing team to ensure seamless optimization at all stages of development. Whether you need early stage clone or media screening, detailed process optimization, or a robust commercial production process, the Bionova upstream development team is ready to help. Advanced Upstream Process Development & Optimization.

Bionova’s downstream process development group works closely with our upstream and analytical sciences groups to maximize yields and minimize impurity content. Rapid development of robust downstream processes.

Successful development of biologics formulations. Bionova has extensive experience in the successful development of formulations for mAb, Fab, ADC, bispecific, enzyme and other complex biologics.

Bionova provides pilot scale production services for pre-clinical toxicology studies, process scale-up work and other research needs requiring material generated at bioreactor scales of 50L or higher. Bionova’s pilot operation has the flexibility operate with full batch records and QA oversight (both Bionova and client) to provide the documentation and compliance required for GLP studies.

Bionova’s state-of-the-art, commercial-ready GMP biologics manufacturing facility opened in 2021 and is currently producing clinical supply for clients. 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.”

Bionova’s Quality Control group provides analytical support to all client GMP manufacturing programs and maintains a functioning, compliant facility.

In many ways, the Project Management team is the face of Bionova to clients. We manage all aspects of project scope and timing internally and externally and communicate regularly with clients. We seek to build trust and to become an indispensable resource to clients.