The path from early discovery of biological drug targets through process development and production, quality control to drug registration and clinical trials is highly technical and arduous. Mistakes at any stage will determine whether the biological drug can be successfully produced and used to treat patients as a commercial product. With increasing competition for the same target, development of different types of multi-specific antibodies are emerging. However, the different types of antibodies bring new challenges in the development of a manufacturing process and scale-up to production.
2021 bioSeedin Annual Conference will be held on 23-24 November 2021 at the Shanghai Himalayas Art Museum in conjunction with the 3rd Biopharma Developer Innovation Conference. The meeting will focus on bispecific antibody discovery, process development and quality control. Bioworkshops will attend the meeting to share their rich experience in the upstream and downstream process development and manufacture of bispecific antibodies with participation in the Trade Exhibition and Dr Alex Zhu, Director of Cell Culture giving a presentation.
Date: 23 - 24 November 2021
Location: Shanghai Himalayas Museum
Speech time: 14:30-15:00, 23 November 2021
Process development and scale-up of bispecific antibodies - The Same Goal Through Different Paths"
Speaker: Dr. Alex Zhu, Director of Cell Culture Process Development, Bioworkshops
Booth No.: A22
Bispecific antibodies are a category of engineered antibodies which have become a hot spot in the field because they have potentially broad application in immunotherapy of tumors with high efficacy. Engineering antibodies with multiple affinities can increase efficacy under certain conditions and overcome side effects of traditional monoclonal antibody combinations. Although their complex and unnatural structures lead to some unique technical challenges in process development and scale-up to commercial production, there are some commonalities between different molecules that can be used for overcoming the challenges. In this speech, Dr. Alex ZHU, Director of Cell Culture at Bioworkshops, will introduce the key points of concern and development strategies at different stages of bispecific antibody process research (CLD, upstream and downstream processes), including some practical case studies to explain how make products that consistently meet quality requirements at production scale.