Website of the conference

The 4^th Antibody Drug Industry Development Conference will be held at the Jeurong Hotel in Shanghai on22-23 October 2021. The conference is divided into three tracks covering innovation and development, process optimization and quality for clinical antibody drugs, biosimilars, formulation, and industry updates with focus on the development of China's antibody industry. The meeting provides industry and academic perspectives on the direction of development, quality research, production processes, laws and regulations and other hot issues of concern.

Quality has always been the key value of Bioworkshops in the development and manufacturing of biopharmaceuticals. In the quality track, Dr. Nick Kotlarski, COO of Bioworkshops, has been invited to explain how to build a quality system for biologic drug development and manufacturing to comply with Good Manufacturing Practices.

Conference information

Date: 22 - 23 October 2021

Location: Jeurong Hotel, Shanghai

Speech time: 10:00-10:30, 23^rd October 2021

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

Speaker: Dr. Nick Kotlarski, COO Bioworkshops

Booth No.: A14

Speech summary

Dr. Nick Kotlarski, Chief Operating Officer of Bioworkshops, has been invited to speak on the topic " Current practice in GMP compliance for mAb investigational medicinal products". The presentation will outline the GMP regulations of NMPA, FDA, and EMA specifically for monoclonal antibody products, and explain in detail how to comply with these requirements for early-stage clinical products. The presentation will explain current industry practice for development and manufacturing of antibody drugs in the clinical development stage referencing the GMP guidelines for drug substance and finished product to ensure that the safety and quality of the product is controlled.