The 4^th Antibody Drug Industry Development Conference held on 22 - 23 October 2021 at the Shanghai Jeurong Hotel was a resounding success. A full house of antibody drug research and development industry experts gathered for both days to actively participate in the parallel sessions, trade show, and networking. Dr. Nick Kotlarski, Chief Operating Officer of Bioworkshops, gave an invited presentation on practical GMP compliance for clinical antibody products in the "Quality and Clinical" track.

Monoclonal antibody drugs have unique advantages with characteristics of high specificity, strong targeting, and low toxic side effects. Monoclonal antibody therapies have become one of the fastest growing product classes in the pharmaceutical industry. However, the transition of a candidate molecule from laboratory to clinical or commercial production is extremely complex. Starting from preclinical development and with increasing rigor through early clinical research (Phase I/II), late clinical research Phase III, and to commercial production, the requirements of Good Manufacturing Practices (GMP) must be followed to ensure the safety, quality, and reproducibility of drugs.

The presentation from Dr. Kotlarski provided an overview of the specific GMP regulations for monoclonal antibodies published by NMPA, FDA, EMA and harmonization initiatives. Dr. Kotlarski also shared benefit of his years in the biopharmaceutical industry to explain in detail how to carry out the production of antibody drugs in compliance with GMP during the major research and development stages. Case studies of the current industry practice for drug substance production and drug product manufacturing at Bioworkshops were presented, emphasizing that data integrity is critical as well as the physical controls for raw materials, facilities, processes and equipment as products progress through the phases of R&D, toxicology, phase I clinical, phase II clinical and phase III clinical.

The development and manufacturing services provided by Bioworkshops comply with regulatory requirements of multiple regulatory authorities. The company’s quality management system defines requirements for validation and process control strategy to match the stage of development. Bioworkshops are committed to providing efficient and economical biopharmaceutical service solutions for global customers, that shorten the drug development cycle and reduce the time taken for drugs to enter clinical trials and reach patients by ensuring quality and regulatory compliance.