Anthony Newcombe, Managing Director
Anthony has made significant contributions to the field of biologics and AAV gene therapy over the past 25 years. As a co-founder and Chief Operating Officer at VectorY Therapeutics, he played a pivotal role in developing engineered capsids, scalable AAV manufacturing, and innovative gene therapies for the treatment of neurodegenerative diseases. His prior experience as Senior Director at Samsung Biologics involved coordinating tech transfers into the world’s largest monoclonal antibody GMP production facility in South Korea. During his time at PAREXEL International, he conducted over 80 GMP audits, advising on corrective actions to align with EMA and FDA standards and his regulatory CMC expertise contributed to successful biosimilar approvals in the European Union.
Advancing Biologics Development
At GSK Biologicals, Anthony led global process characterisation and validation activities, supporting the development and production of Mosquirix, the first malaria vaccine. His role at Pfizer Biotechnology Ireland involved managing the technology transfer and scale-up of Tanezumab, a monoclonal antibody for the treatment of acute and chronic pain. Currently serving as the Managing Director and co-founder of Applied Biopharm, Anthony provides strategic guidance across GMP manufacturing, compliance, auditing, Quality Assurance (QA), process development, and regulatory CMC. He holds a PhD in Physical Biochemistry from the MRC National Institute for Medical Research and a BSc(Hons) in Biochemistry from the University of East London.
Integrated Compliance Solutions
Applied Biopharm Consulting specialises in GMP auditing and compliance, Manufacturing Science & Technology (MSAT), technology transfer, GMP manufacturing, regulatory CMC and Quality Assurance (QA). Our team assists global clients developing cutting-edge biotherapeutics, including AAV gene therapies, antibodies, PEGylated proteins, vaccines, and recombinant enzymes, offering solutions tailored to meet the dynamic requirements of the biopharmaceutical industry. Our extensive industry knowledge positions us as key contributors shaping the future of biopharmaceutical development. In 2024, Applied Biopharm Consulting was recognised as the ‘Best GMP Compliance Service Provider’ by the Irish Enterprise Awards.
Get in touch
We look forward to the opportunity to work with you remotely or on-site to support your biopharmaceutical development and manufacturing needs. To contact us, please email contact@appliedbiopharm.com with your information and a brief description of your enquiry and we will respond as soon as possible. If you prefer to speak with someone directly, please feel free to call on
+353 (0)873634486
(UK/GMT)