Recent Advancements in Antibody Purification

Speakers:

Aled Charles, R&D manager Scale up and early development team, AstraZeneca
Aled has more than 15 years of biomanufacturing and downstream process development experience. After managing the downstream production team at a CMO based in Cambridge, Aled has been at AstraZeneca for 10 years where he manages the scale up and early development team. Aled has transferred multiple projects to clinical and commercial facilities within the AstraZeneca network.

Takuo Kawase, Senior Manager and Scientist, API Process Development, Chugai Pharmaceutical
Takuo Kawase is Senior Manager and Scientist in the Downstream Process Development group in Chugai, a member of the Roche group. He is currently leading the emerging technology development and implementation on continuous manufacturing, process intensification with novel purification technologies and digital transformation as well. He has 12 years of experience in biopharmaceutical industry and held multiple positions including process development, project management, drug discovery and protein engineering. He received B.Eng. and M.Eng. in Biological Science and Technology from Tokyo University of Science.

Ashok Mishra, Head R&D Downstream department, Lupin Pharma, India
Dr. Ashok Mishra is a process development expert for biosimilar products for global markets. He is currently heading the R&D Downstream department, Biotechnology division of Lupin pharma, and providing direction to cross-functional process and analytical teams. He has extensive experience designing drug substance manufacturing process, process characterization, virus clearance validation, scale up, refolding, PEGylation, and technology transfer for process validation and commercial manufacturing.
Prior to Lupin, Dr. Ashok has worked at Intas Biopharmaceutical. There he was responsible for Downstream process development for the several biosimilar molecules based on bacterial and mammalian platform, development of PEGylated product and novel formulations. He was also responsible there for the plasma fractionation and development of the various plasma products.
Prior to Intas, Dr. Mishra has worked at Bharat Serums & Vaccines. There he was responsible to develop the purification process of several tumor markers, antigens from plural fluid, plasma, and card blood for diagnostics purpose.

Gunnar Malmquist, Principal Scientist, Cytiva
Gunnar Malmquist is a principal scientist at Cytiva and an analytical chemist by training with focus on chromatography and data analytics. He started his career at Pharmacia Fine Chemicals in 1979, working with quality control of chromatographic separation resins. Hewas later involved in the development of the ÄKTA chromatographic system and the UNICORN software, before moving in 1997 to development and characterization of preparative chromatographic resins. He has been responsible for the design of several of the leading resins on the market, including MabSelect and Capto. Currently he is focused on resin design strategies, Quality by Design and PAT, as well as using multivariate data analytics and mechanistic modelling to understand biomanufacturing processes.