Satish Muchakayala, Director of Regulatory Affairs, Touchlight Genetics Ltd, UK
Satish has 16 years of experience covering development and life cycle maintenance of both small and large molecules. Currently he is supporting the development of nucleic acid based vaccines and providing CMC regulatory advice for partners to enable the utility of doggybone DNA technology in vaccines and advanced therapy applications.
Antibiotics in biopharmaceutical production
As per the WHO, antimicrobial resistance (AMR) is a global health threat and a complex problem that requires a united multisectoral approach. In the interest of patients and environmental safety, regulators around the globe are discouraging the use of antibiotics in all areas of their utilisation ie, not only at ...
CMC acceleration is driven by a scientific revolution
The role of CMC technical and regulatory experts is essential for ensuring continuous innovation and successful regulatory approvals
Regulatory Framework for Platform Technologies
Several novel manufacturing technologies and platforms, for example, messenger ribonucleic acid (mRNA) platform, synthetic DNA (doggybone (dbDNA)) platform, have recently emerged to produce vaccines and advanced therapy medicinal products (ATMPs) for human use. However, the regulatory framework for such platform technologies is not fully developed. There is significant interest in utilising platform approaches for drug development and for the commercial production of human medicines. Thus, some form of regulatory guidance and pathway, similar to the EU platform technology master le (PTMF) system that is used in the regulatory approval of veterinary vaccines, would benefit the human vaccines industry.