Biologicals Process Development Services
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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.
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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.
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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.
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Non GMP Protein Productions
We offer fast pace non GMP manufacturing for protein and cell based products production with flexible schedule.
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Analytical Services
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
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Upstream 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.
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Downstream Manufacturing
JOINN Biologics’ downstream manufacturing offers cGMP production service from with customized process including depth filtration, Protein A, CEX, Virus inactivation, AEX and UF-F!
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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!
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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.