In collaboration with world’s leading large-scale mammalian cell culture manufacturing company, cell line and process development for therapeutic antibodies have proceeded to reach global standards.

PMBP is focusing on mammalian cell culture derived therapeutics as native molecules or enhanced by ADCC or ADC technologies. We are using high titre expression systems as a basis for economicproduction of our therapeutics. Our media high throughput screening and our feeding strategy support the productivity of host cells. In the downstream development we are evaluating a broad range of resins in order to keep high yields of the upstream titre. For the drug products, we have a formulation development for liquid and lyophilized forms and fill and finish equipment for liquid and lyophilized vials as well as for prefilled syringes from Bausch & Stroebel, Germany. A broad spectrum of analytical methods is applied as guidance for process development, product characterization, quality control and stability testing to support the highest quality of our therapeutics. Our independent quality assurance and regulatory affairs units guarantees that our therapeutics are produced according to the regulatory quality standards and approved by the regulatory authorities worldwide to the benefit of our patients.