This presentation discusses our innovative methods and analytical strategies employed in the production of bispecific antibodies for toxicology and clinical batches. This comprehensive study focuses on how we analytically monitor bispecific antibody manufacturing using the co-culture of two different cell lines in a single bioreactor and the use of column-based redox technologies to streamline the production process. Key topics include:
1. Introduction to Bispecific Antibodies: An overview of multi-specific antibodies, their clinical applications, and the significance of their development in the pharmaceutical industry will be covered. We will review a general explanation of the traditional method for producing charge-based bispecific antibodies, which involves the separate production of each parental homodimer in two bioreactors before combining them to form the bispecific antibody.
2. Innovative Manufacturing Process: A detailed explanation of the co-culture method and column-based redox process used to produce bispecific antibodies will be discussed. This includes the simultaneous production of parental homodimers in a single bioreactor followed by the redox/capture process involving protein A chromatography.
3. Comprehensive Analytical Monitoring: The importance of analytical monitoring to ensure the correct assembly and quality of bispecific antibodies will be discussed. Our strategy for monitoring homodimer ratios prior to redox, ensuring correct bispecific assembly, product quality, and impurity removal will be described. This includes using techniques such as High-Performance Liquid Chromatography, Mass spectrometry, and Capillary Gel Electrophoresis.
Learning Objectives:
Upon completion, participants will be able to identify the benefits of the streamlined co-culture and column-based redox approach in reducing production time and material use while maintaining bispecific antibody quality
Upon completion, participants will be able to explain the importance of analytical monitoring in ensuring the correct assembly and quality attributes of bispecific antibodies throughout the manufacturing process
Upon completion, participants will be able to understand the concept of multi-specific antibodies and the strategies for heterodimerization
