About

Anthony Newcombe brings over 25 years of extensive industrial experience to support biologics and ATMP manufacturing, Quality Assurance (QA), and GMP compliance. He was previously a co-founder and Chief Operating Officer at VectorY Therapeutics, contributing to the strategic direction of the company’s development of engineered capsids, scalable AAV manufacturing processes and novel gene therapies for the treatment of neurodegenerative diseases. Before this role, he served as a Senior Director at Samsung Biologics, where he was responsible for managing tech transfers for clinical and commercial campaigns at the world’s largest single-capacity monoclonal GMP facility in Incheon, South Korea.

Reporting to a former FDA District Director, Anthony previously worked at PAREXEL International and conducted over 80 GMP audits of biologics drug product and drug substance facilities. He conducted audits and mock inspections, advising clients on the implementation of corrective actions to meet EMA and FDA expectations and maintain GMP compliance. As a member of the regulatory affairs group, Anthony also provided regulatory support for Chemistry, Manufacturing & Control (CMC) activities, including manufacturing and process validation. Anthony was involved in the preparation and review of regulatory submissions for EU and US marketing applications and served as a CMC reviewer for the first successful biosimilar monoclonal antibody approved for marketing in the European Union in 2013.

Anthony has also held a technical leadership role within the Global Industrial Operations group at GSK Biologicals in Belgium. In this capacity, he managed global process characterization and validation groups to support global vaccine manufacturing at GMP production facilities in the EU, US, and Asia. He played a key role in supporting the production of Mosquirix, the world’s first malaria vaccine, which received a recommendation for approval from the European Medicines Agency in 2015. Additionally, he was a member of the technical leadership team at Pfizer Biotechnology Ireland, where he coordinated the technology transfer and scale-up of Tanezumab, a late-stage monoclonal antibody for the treatment of acute and chronic pain.

At Applied Biopharm, Anthony continues to provide strategic guidance to support the development and GMP manufacturing of biologics and advanced therapies. His specialities include assisting with GMP compliance, auditing and inspection readiness, process development and manufacturing, deviation management, developing corrective action plans in response to compliance issues and assisting with responses to regulatory agencies. Anthony also shares his expertise through presentations at industry conferences and regularly publishes articles in leading industry journals.

Anthony received his PhD from the Department of Physical Biochemistry at the MRC National Institute for Medical Research in Mill Hill, London (now part of the Francis Crick Institute, London, UK), and holds a BSc Biochemistry degree from the University of East London. He has authored over 30 scientific and bioprocess related publications.