The 3^rd China International Biochemical Pharmaceutical Industry Conference will be held in Suzhou International Expo Center on 29 -30 September 2021. The theme of this conference is "Integrating the full pharmaceutical industry chain for unmet disease”. The meeting and trade show will cover antibody drugs, gene cell therapy, and small molecule pharmaceutical products, exploring innovative technologies, government policies and solutions from perspectives of various contributors to the industrial chain. It is expected to attract more than 150 exhibitors and in excess of 5,000 delegates.

Conference information

Date: 29^th-30^th September 2021
Location: Suzhou International Expo Center

Speech time: 29^t September 2021， 10：45

Topic: Current practice in GMP compliance for mAb investigational medicinal products

Speaker: Dr. Nick Kotlarski, COO, Bioworkshops

Booth number: C1-D03

Speech abstract

The talk compares the GMP regulations of NMPA, FDA, and EMA for monoclonal antibody products giving a detailed interpretation of the requirements during clinical development stages and how these fit into some harmonized standards. Dr Kotlarski will share current industry practice guidelines specific to drug substance and drug product manufacturing giving examples to explain some best practices in quality management and facility operation to ensure that the safety and efficacy of products is controlled.