A.p. Kalanidhi
director
Takeda
Singapore
Biography
More than 30 years in the field of Viral and other vaccine projects for Human and animal use. •Process consultancy : Manufacture of viral vaccines for animals and humans requiring cell culture processes. Consultancy for all stages of product development like strategy , seed banking, process, methods, scale-up developments and trouble shooting for process related issues like yield improvement and quality improvement etc. •Regulatory & Compliance: Preparation of IND and CMC documents ,review of the technical contents of process, manufacturing & analytical sections. Execute GMP compliance surveys for Pre-Approval Inspections; .
Research Interest
More than 30 years in the field of Viral and other vaccine projects for Human and animal use. •Process consultancy : Manufacture of viral vaccines for animals and humans requiring cell culture processes. Consultancy for all stages of product development like strategy , seed banking, process, methods, scale-up developments and trouble shooting for process related issues like yield improvement and quality improvement etc. •Regulatory & Compliance: Preparation of IND and CMC documents ,review of the technical contents of process, manufacturing & analytical sections. Execute GMP compliance surveys for Pre-Approval Inspections; .
