Process simulations can bridge R&D with production

Process simulations can bridge R&D with production

Mar 24, 2020

In a Pharmaceutical Manufacturing piece, CRB’s Phil Lyman shows how simulations can navigate tricky path from research to commercial production

Cell and gene therapy manufacturers are pioneers by definition, and by necessity. Researchers have neither volumes of historic data to draw from, nor tried-and-true paths to make the leap from research and development to large-scale commercial production. It’s an uncharted journey that carries great risk and great reward.

In a recent column published by Pharmaceutical Manufacturing, Dr. Philip Lyman, CRB’s Director of Process Simulation, explores the role simulations can play in bridging the gap between R&D and production. He addresses the unusual position occupied by cell and gene researchers: “In other, more established areas, process simulation works by applying what we know already about a given scenario. In the case of cell and gene therapy facilities, process simulation works differently. It uses those variables and relationships to measure your facility’s sensitivity to risk and to find opportunities to bolster resilience, improve efficiencies and guarantee a successful business outcome.”

The stakes are high. The COVID-19 pandemic illustrates the world’s desperate need for quick and effective therapy solutions — a sense of speed-to-market that, Lyman notes, cell and gene therapists know all too well.

“Shareholders and business leaders need a return on their large investment. Front-line operators need a safe and efficient working environment. And then there are patients, the most important stakeholders of all, who need access to lifesaving therapies before they succumb to illness. Responding to these pressures is a matter of upholding quality while moving quickly.”

From granular and macro levels to operational organization and department efficiency, Lyman’s piece explores how process simulations can reveal gaps in your facility’s workflow and productivity. He addresses how simulations account for risks, such as costs or contamination. On the latter, Lyman is blunt: “Without proper mitigations in place, accepting a contaminated sample is like catching a live grenade; your whole operation could be disabled for an undefined period while you scramble to clean up the mess that results. Simulations can protect against this risk by helping you develop resilience against contamination events in the most efficient and cost-effective way possible.”

To read the full article, click here.