Malcolm Berry, PhD – Multi-Stage Continuous Processing for APIs

 

Malcolm Berry, PhD - Multi-Stage Continuous Processing for APIsDr. Berry is globally recognized as one of the leading innovators in continuous processing for small molecules. He was instrumental in the development of the world’s first multistage continuous manufacturing platform, designing the lab-based technology and design workflow for APIs at GlaxoSmithKline (GSK). He led a large multifunctional team of more than 50 people across R&D and multiple manufacturing sites to strategically transform batch production of Fluticasone Propionate to continuous processing within a few years. The manufacturing module was installed in Singapore in 2015, commissioned in 2016 and validated in 2017. The new continuous processing was filed with EU and US regulatory agencies in 2018—and was possibly the first multistage continuous API process to receive regulatory approval. Dr. Berry was recognized for his outstanding leadership with a prestigious R&D award prior to leaving GSK.

His consulting expertise includes identifying the benefits of continuous processing in research and manufacturing, single vs. multi-stage work flow impacts, appropriate equipment selection, best practices for operation and maintenance, robust production, PAT application and integration, and preparing for regulatory agency approvals.

Expertise 

  • Continuous process design, integration and implementation
  • Operational and material management
  • PAT application and integration
  • Regulatory preparation