December 11, 2020, the 2020 Pharmaceutical Annual Technical Summit co-sponsored by the Pharmaceutical Professional Committee of the Shanghai Pharmaceutical Association and the School of Pharmacy of Fudan University, was successfully held at the Shanghai Jeurong Hotel. The conference drew a strong panel of experts in the field of pharmaceutical development and formulation. The topics covered by the presenters covered from discovery to commercial production, with focus on industrial pharmaceutical formulation and cutting-edge development technology. The conference sessions were broadcast live online, reaching a cumulative audience above 200,000 participants.

Dr. Nick Kotlarski, Chief Operating Officer of Bioworkshops, was invited as a special guest to present on the current practices in scale-up and production of antibody therapeutics. Dr. Kotlarski outlined the GMP regulations for investigational antibody medicinal products, detailing the core content and contrasting differences for EU, US, and China healthcare authorities. Using a platform fed-batch cell culture process for manufacture of monoclonal antibodies as the case-study, Dr. Kotlarski highlighted key points to consider at the major phases of development from laboratory research to commercial production sharing corresponding control measures.

Dr. Kotlarski also shared Bioworkshops current practice as a case-in-point for multiproduct clinical production of biologics. The pharmaceutical quality system incorporating expert risk assessment is essential to assure product safety and effectiveness for clinical candidates. To that end, Bioworkshops operates with more than 700 dual language SOPs, and completed more than a 1000 validation documents to record the qualification of the GMP plant and equipment. This practice exceeds the minimum regulatory expectations, and is an investment to safeguard the quality safety, and regulatory compliance of customer products to deliver in the shortest possible time and accelerate the drug R&D cycle.