JOINN Biologics
JOINN Biologics, located in Northern California, offers a comprehensive range of services across all phases of the drug life cycle, including development, manufacturing, and quality assurance/control, with advanced facilities and technologies.
Services
JOINN Biologics provides a comprehensive range of services across all phases of the drug life cycle. Their support services include quality assurance and quality control. The development services offered encompass developability assessment, cell line development, process development, analytical assay development & qualification, and formulation development. Manufacturing capabilities include upstream manufacturing, downstream manufacturing, and fill and finish. Additional services such as biomass production and pre-clinical services are also available.
Location
JOINN Biologics is located in Northern California, about 12 miles away from Berkeley and 23 miles from San Francisco. The Richmond, CA facilities have been recommissioned and now house new cell culture, solution preparation, downstream purification, and filtration systems. The location is strategically positioned to serve both local and international clients.
Advanced Manufacturing Capabilities
JOINN Biologics' facility includes upstream manufacturing suites equipped with a wide variety of cell culture production equipment and advanced in-process testing technologies such as rocker-based bioreactors, cell culture analyzers, and various bioreactor systems. Their facility also features stainless steel bioreactors up to 1000L production capacity and single-use bioreactors up to 500L production capacity. The downstream GMP suites adhere to the latest industry standards of protein purification.
Quality Control and Assurance
The Quality Control department at JOINN Biologics provides in-house analytical testing capabilities to support ongoing cGMP operations. The Quality Assurance system is fully aligned with applicable regulatory guidelines and promotes continuous quality improvement. This ensures that all products and processes meet stringent quality and regulatory standards, providing clients with reliable and safe outcomes.
Specialized Platforms
JOINN Biologics offers a proprietary cell line development platform called JOINN-CHO, designed for generating biomanufacturing cell lines. Additionally, the company utilizes the CHOZN® platform developed by MilliporeSigma for cell line development. These platforms are intended to alleviate industry bottlenecks and enhance the efficiency of cell line development processes. Formulation development includes screenings done in 96 well format and confirmation using viscosity, activity, and aggregation as readouts.