Clinical Manufacturing

Bionova Scientific is currently constructing a new, state-of-the-art biologics manufacturing facility at our Fremont, California headquarters. We look forward to serving our clients’ clinical and commercial manufacturing needs starting in 2021. We are booking our cGMP slots now so contact us for more information.

Manufacturing Space

Cytiva FlexFactory™ Single-use Bioprocess Platform

MCB and WCB Generation

Thaw and Expansion: Shake Flasks, Wave Bioreactors, Seed Train Single-use Bioreactors

Production: Two 2kL Trains including 50L, 200L, 500L, 1kL, and 2kL bioreactors for Fed-batch and perfusion processes

Harvest: Two-Stage Filtration and Clarification

Three-Step Purification with dedicated Pre and Post Viral Downstream Process Areas

Single Use Chromatography and UF/DF Technology

On-The-Floor Quality Oversight

Commercial Ready GMP Facility with personnel, material, product, and waste flow

Warehouse and Storage

MCB and WCB Storage

Walk-in 2 to 8 degree refrigerator storage

Walk-in minus 40 degree freezer storage

GMP Warehouse

Utilities and Others

Uninterrupted power supply (UPS) and back-up generator

Segregated and independent Heating/Ventilation/Air Conditioning (HVAC) system

Redundant chiller and boiler for uninterrupted HVAC system

On-site Purified Water and Water-For-Injection (WFI) system

On-site maintenance shop and Building Management System (BMS)

Dedicated office for Person-in-Plant (PIP)