Bionova Scientific

Bionova Scientific is a biologics contract development and manufacturing organisation (CDMO) specialising in the development and production of monoclonal antibodies (mAbs) and other therapeutic proteins using mammalian cell culture processes.

Founded in 2014 and acquired by the Asahi Kasei Group in 2022, Bionova Scientific offers world-class biologics CDMO services built on a foundation of strong process development and analytical science, with a staff that brings decades of experience in late-stage and commercial launch projects.

With its high-quality, customised biomanufacturing services, cutting-edge process development expertise, and data-driven risk minimisation strategies, the company is renowned for helping client projects move quickly from concept to robust GMP production. Bionova Scientific's operations are optimised for multi-product manufacturing of monoclonal antibodies and other recombinant proteins.

Key Products and Services:

Research and Development Services:

Protein Production Services: Expertise in producing high-quality recombinant proteins to support various stages of drug development.
Analytical Sciences: Comprehensive analytical support, including method development, qualification, and product quality assessment.

Development Services:

Cell Line Development: Generation of robust and high-yielding mammalian cell lines for therapeutic protein production.
Upstream Process Development: Optimisation of cell culture processes to enhance productivity and product quality.
Downstream Process Development: Development of efficient purification processes to ensure product purity and yield.
Formulation Development: Design of stable and effective formulations for therapeutic proteins.

Manufacturing Services:

Pilot Production: Small-scale production runs to support preclinical and early-phase clinical studies.
GMP Manufacturing: Compliance with Good Manufacturing Practice standards for clinical and commercial production.
Process Characterisation Studies: Detailed studies to understand and control manufacturing processes.

Support Services:

Quality: Commitment to maintaining the highest quality standards across all operations.
Quality Control: Rigorous testing and validation to ensure product safety and efficacy.
Project Management: Dedicated teams to oversee project timelines, budgets, and deliverables.

In line with its commitment to meeting the evolving needs of the biopharmaceutical industry, Bionova Scientific has embarked on strategic expansions. In February 2023, the company initiated a project to quadruple its GMP biologics manufacturing capacity at its Fremont, California headquarters.

Furthermore, in June 2024, Bionova announced plans for a new plasmid DNA GMP facility in The Woodlands, Texas, aiming to support cell and gene therapy developers with high-quality plasmid DNA production.

Bionova Scientific's dedication to technical excellence, client-focused culture, and continuous innovation positions it as a trusted partner in bringing life-saving treatments to patients worldwide.