JOINN Biologics - Process Development and Manufacturing Service
JOINN Biologics is a contract manufacturing service company, located in San Francisco Bay Area with professional team and cGMP facility in JOINN Innovation Park. JOINN Biologics offers process development, including cell line development and cell culture, upstream process development, downstream process development, analytical services. The company also provide therapeutic protein drug cGMP manufacturing, from GLP IND to clinical phase manufacturing. There is a collaboration opportunity for clinical phase III and commercial stage cGMP manufacturing.
Biologicals Process Development Services
Cell culture and cell line development
JOINN Biologics has a team of experts in the production of antibodies and recombinant proteins using various mammalian cell expression systems. Our state of art technology platform offers highly efficient cell line development process and guaranteed quality products for clinical applications.
Upstream process development
JOINN Biologics’ upstream process development group offers state-of-art cell culture development labs. We can provide exceptional development support for cell culture processes from small scale to pilot scale.
Downstream Process Development
Our experienced downstream process development team helps customers to develop most cost-effective purification protocols for their therapeutic protein products, and provides protein integrity, purity, and stability information for each batch of the protein products, to enable a smooth transfer to manufacturing scale.
Non GMP Protein Productions
We offer fast pace non GMP manufacturing for protein and cell based products production with flexible schedule.
At Joinn, we providing expert quality and regulatory strategies, consultation and execution, Joinn helps clients stay on the path to approval process. Not only we can also help you to speed up product approval but we also overcome any quality, regulatory and technical hurdles that may stand in the way of product development and approval in US.
Therapeutic Protein cGMP Contract Manufacturing
JOINN Biologics’ upstream manufacturing group offers cGMP production service from vial to final production vessel using stainless steel bioreactor and disposable bioreactor train with 1000L production capacity. We can harvest cell culture by centrifugation, depth filtration and micro filtration. We provide cost efficient manufacturing solutions to clients.
JOINN Biologics’ downstream manufacturing offers cGMP production service from with customized process including depth filtration, Protein A, CEX, Virus inactivation, AEX and UF-F!
Fill and Finish
We offer clinical stage fill and finish of therapeutic protein drug with cGMP compliance. The fill and finish facility includes freeze dryer, class 100 clean room, pass through autoclave, pass through dryer and full set of SOP!
cGMP Commercial Manufacturing
JOINN Biologics offers the potential Phase III and commercial manufacturing opportunities with built to suit options based on the therapeutic commercial stage manufacturing process and procedures.
We have talents know your protein technology transfer, process development and manufacturing experience with ensurace of best quality and cGMP compliance
We offer one stop service for your cell line development, upstream and downstream process development, cGMP manufacturing and non-GMP produdction, along with analytical services, quality control and regulatory services.
The US cGMP facility in San Francisco Bay Are has multiple therapeutic drug manufacturing production lines, with established cGMP operating enviroment to ensure your project successful!
We offer the global process development and cGMP manufacturing services, which would meet the local country production needs.