Satish Muchakayala

Satish Muchakayala

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.

  • AdobeStock_410157798 (1)
    Article

    Antibiotics in biopharmaceutical production

    2022-06-23T09:46:00

    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 ...

  • AdobeStock_226352071
    Editorial

    May 2022 Editorial: CMC acceleration is driven by a scientific revolution

    2022-05-13T14:51:00

    The role of CMC technical and regulatory experts is essential for ensuring continuous innovation and successful regulatory approvals

  • adobestock_237602801_optimized
    Focus

    Regulatory Framework for Platform Technologies

    2022-04-18T14:20:00

    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.