ACMC2020 (the 2nd Asia Biopharma Continuous Manufacturing and BioProcessing Conference 2021) was successfully held on September 16-17, 2020 in Shanghai. The conference was attended by many biopharmaceutical industry leaders and CDMO experts, and addressed the latest hot topics for industry development including relevant policies , the future development direction, and the rising tide of international innovation in the local sector for biological drugs.
In the production process of biological drugs, Fed-batch cell culture with batch purification steps are most commonly used for preparation of monoclonal antibodies. In pursuit of reduced production costs, improved plant utilization, and greater process control, a growing number of major biopharmaceutical companies are exploring continuous flow manufacturing processes. In this context, the organizer held a forum with the theme of upstream and downstream innovation process, continuous processing, and intelligent production 4.0. Dr. Nick Kotlarski, COO of Bioworkshops, was invited as a guest speaker.
Dr. Kotlarski introduced that a biosimilar of omalizumab from Biosana Pharma, was the first case reported of a fully integrated continuous process to enter clinical trials, and explained the continuous flow process and current development. Analyzing the cost-model for monoclonal antibodies, Dr Kotlarski pointed out that continuous processing is used in production because it can offer significantly increased capacity for the same investment cost relative to batch or fed-batch operation. It generally gives higher utilization of facilities and increases the level of control of processes. However, it has not been widely used for biologic drug products at present because enabling hardware has only recently become available and the process development requires commitment of different expertise.
In terms of the corresponding plant design, Dr. Kotlarski pointed out that regardless of whether continuous processing or the traditional fed-batch processes are employed, the plant construction and supporting infrastructure need to support the whole business . Site selection, the size of overall facility, and the floor-loading are all key factors to be considered in the layout of facilities. He recommended that flexibility should be considered during design, and the plant designed for rapid adoption of continuous processing from a basis of fed-batch operation.
Dr. Kotlarski introduced the plant design concept of Bioworkshops. He presented that Bioworkshops currently operate fed-batch cell culture and batch purification, and considered how to meet the future requirements of customers and effectively reduce costs with efficient and high-quality delivery in the design of their facility.
As a biologics CDMO, Bioworkshops focuses on quickly developing and manufacturing clients' products for clinical studies in China, the Asia Pacific region, the United States, and the European Union, assuring international standards of compliance to transform discoveries into new biological medicines.