Malcolm B. Berry, PhD
GlaxoSmithKline
Continuous Chemistry Team Manager
Malcolm studied for a PhD at Imperial College (1993) and he has 28 years’ experience working in the pharmaceutical industry as an organic chemist; with the last 26 years at GSK, working in process research and development in R&D. Malcolm is best known as a one of the leading innovators in the field of continuous processing for small molecules. Since 2000, he led the development of the lab-based technology and the ways of working for the development of continuous processes for Active Pharmaceutical Ingredients (API) at GSK. He was heavily involved in the design, construction and commissioning of the first multifunctional pilot plant for continuous flow chemistry, within the pharmaceutical industry. Malcolm led the teams that developed the first 5 processes that ran in this facility, producing cGMP API for clinical evaluation and transfer to manufacturing.
The highlight of his GSK career was to successfully lead a large multifunctional matrix team of >50 people across R&D and multiple manufacturing sites, to redevelop an existing GSK asset – Fluticasone Propionate (FP) – from a batch process into a continuous process. This was the first multistage continuous process to an API anywhere in the GSK manufacturing network. The factory module was installed in Singapore in 2015, commissioned in 2016, validated in 2017 and the new process was filed with regulatory agencies in Europe and USA in 4th quarter 2018 and was approved by FDA and EDQM in December 2019.
Malcolm has changed career and is now working as a consultant for MB Chemistry Consulting Ltd, in the design and implementation of continuous processes for API.
The highlight of his GSK career was to successfully lead a large multifunctional matrix team of >50 people across R&D and multiple manufacturing sites, to redevelop an existing GSK asset – Fluticasone Propionate (FP) – from a batch process into a continuous process. This was the first multistage continuous process to an API anywhere in the GSK manufacturing network. The factory module was installed in Singapore in 2015, commissioned in 2016, validated in 2017 and the new process was filed with regulatory agencies in Europe and USA in 4th quarter 2018 and was approved by FDA and EDQM in December 2019.
Malcolm has changed career and is now working as a consultant for MB Chemistry Consulting Ltd, in the design and implementation of continuous processes for API.