Platforming Antibody Drug Conjugate Process Development and Manufacturing using Single-Use Technologies
Sponsored by: Sartorius Stedim Biotech
- Antibody Drug Conjugates
- Single Use Manufacturing Technologies
- Membrane Chromatography
Date: 30 April
Time: 3PM London/10AM New York
Focusing on new concepts for membrane chromatography
Antibody-Drug Conjugates (ADCs) represent a significant area with clinical and economic growth for the biopharmaceutical market. ADCs combine the targeted specificity of a monoclonal antibody with a cytotoxic small molecule and are manufactured by covalent binding of the monoclonal antibodies to the highly toxic small molecules via a chemical linker. There are hundreds of ADC candidates in development and analysts expect the market for these drugs to continue to expand. Production and analysis of varying quantities of ADC candidates is required to support research, process development, clinical development and commercialization of the molecules. Sartorius has an integrated platform of products and services to support ADC development and manufacturing needs from molecule inception through commercialization.
Single-use manufacturing technologies allow companies to quickly bring cGMP manufacturing capability online with less capital investment. In this webinar we present a robust and scalable platform for ADC process development and manufacturing that uses single-use technologies to accelerate development timelines and increase manufacturing predictability while decreasing scale up risks.
This webinar will include a case study presented by the company Abzena. The case study focuses on the implementation of membrane chromatography and cross flow filtration for their antibody drug conjugate process. Abzena developed a novel tandem membrane chromatography approach for ADCs, which refines drug to antibody ratio, reduces the heterogeneity of the drug load bound to the antibody and remove aggregates as well as free payload in a single chromatographic run. Further, the chemical compatibility of the materials used in the platform to solvents typically used in ADC processes will be shown.
Please register now to reserve your spot for this exciting webinar and we look forward to welcoming you to our presentation.
Technology Consultant Bioconjugation
Ian Schwartz joined Sartorius Stedim Biotech in December 2016 as a Process Development Consultant and is Sartorius’ bioconjugate subject matter expert. Ian has over 12 years of experience in the biotechnology industry and specializes in antibody drug conjugate (ADC) and downstream protein purification process development, technology transfer and manufacturing. Ian began his career at Biogen and has moved onto positions of increasing responsibility at ImmunoGen, MedImmune and most recently Agensy, a former affiliate of Astellas Pharmaceuticals, where he started up and led the ADC process development, tech transfer, and manufacturing support group for a number of years.
With more than 13 years in the biotechnology industry, Ian leads Sartorius’ bioconjugate platform and supports process development and scale up of biological and bioconjugate processes for Sartorius’ customers.
Associate Director, Bioconjugate Chemistry
Jieyu Zhou started his career in Shanghai China as a technical service engineer and was working on customer training of macromolecule separation at Agilent technologies in 2006. In 2009, he began Ph. D program at Rutgers University, where he was focused on the protein labeling, protein-protein crosslinking, and bioconjugation research projects. In 2016, Jieyu joined Abzena as a Senior Scientist in bioconjugate chemistry followed by promotion to the principal scientist in 2018. Jieyu has more than 10 years’ experience in designing bioconjugates and processes from the discovery phase, through development, to completion of the transfer to manufacturing. Jieyu’s early work involves studying antibody/protein structure, function, and dynamics through antibody/protein labeling and protein/peptide-protein crosslinking techniques.
Since joining Abzena, Jieyu has developed multiple bioconjugates processes and made more than 200 antibody-drug conjugates with various designs. He leads the Abzena team in collaboration with Sartorius Stedim biotech on developing an ADC process with single-use membrane technology.
Key Learning Objectives
- ADC process development and manufacturing points to consider prior to project commencement
- Scalable platforms for ADC process development and manufacturing using single-use equipment
- Chemical compatibility of Sartorius’ single-use ADC manufacturing platform
- ADC process optimization using Membrane Chromatography and cross flow filtration
- Process Development Scientists
- Process Development Managers
- Process Engineers
- Engineering Directors