The talk will cover the technical especially, the upstream and downstream processing, characterization and clinical use of protein based therapeutics. We will take our experience with two in-house developed biologics as case studies to illustrative our unique capabilities to design and develop complex biologics with speed, quality, and innovation -
1) Unique perfusion process to achieve high PCD and titers for a highly sialylated Fc fusion protein for AMD 2) Process optimization and analytical method validation for Sputnik V vaccine in adenovirus platform for Covid-19
Learning Objectives:
Appreciate the technology used for production of safe and efficacious biologics and applications for the delivery of life saving medicines for human use.
Describe the key process R&D and manufacturing methodologies that govern the development of safe medicines for human use.
Describe the clinical parameters that define the development and validation of safe medicines for human use.
