February 22, 2023 | 3-5PM

Meeting will be in-person and live streamed.
 – Register for Virtual
 – Register for In-person (Institute for Bioscience and Biotechnology Research (IBBR), 9600 Gudelsky Drive, Rockville, MD 20850. Parking is available in lot in front of IBBR.)

Pure Knowledge: Improving Downstream Processing by Deciphering Separation Mechanisms
Joint meeting with CASSS D.C. Area Discussion Group

There are two main applications of separation science in the development and production of biologics; 1) use of chromatographic methods to aid product characterization and detection of impurities and 2) purification of biological products. In the case of purification, multiple chromatography steps are required in downstream processing to remove product and process related impurities that have the potential to affect the safety and/or efficacy of the drug product. The removal of these impurities can be challenged by their interaction with (e.g., host cell proteins) or similarity to (e.g., mis-paired bispecific antibodies) the therapeutic molecule. This meeting will focus on understanding mechanisms that drive the interactions of impurities with the therapeutic molecule and chromatography media and the application of this knowledge towards increasing the purity of therapeutic protein products.

Formation of transient highly-charged mAb clusters strengthens interactions with host cell proteins and results in poor clearance of host cell proteins during downstream processing | Haibin Luo, AstraZeneca

Leveraging Light Chain Binding Avidity for Control of Mispaired Byproducts During Capture of Bispecific Antibodies | Kamiyar Rezvani, AstraZeneca

Haibin Luo is an associated director in Biopharmaceutical Development (BPD) Organization in
AstraZeneca. Dr. Luo leads a CMC (chemical manufacturing and control) team developing new
medicine helping patients with leukemia; he leads a group of scientists developing downstream
manufacturing processes for inhaled biologics; he also leads impurity safety risk assessment for
AstraZeneca global biologics. He has 11-year experience in downstream process development
for biologics such as monoclonal antibody, fragmented antibodies, bispecific/tri-specific/multi-
specific antibodies, and fusion proteins. He has strong background on downstream process
development and clearance of host cell proteins. He is an active author publishing papers in
downstream processing field and active speaker on international conferences. He did his postdoc
trainings at NIAID and University of Maryland before joining AstraZeneca. He received PhD
degree in Drug Design from Chinese Academy of Sciences and bachelor’s degree in
Biochemistry from Shandong University.

Kamiyar Rezvani is currently a scientist at AstraZeneca based in Gaithersburg, MD working in the Purification Process Sciences team within the Biopharmaceutical Development group. Rezvani has worked on early to late-stage downstream process development in the biopharma industry for 6+ years with a recent focus on multi-specific antibodies and high-throughput process development.

New to analytical chemistry or looking to sharpen your skills? Visit NIST’s site for videos and PowerPoints on Tutorials in Analytical Chemistry