2022 | November / December 2022

Integrating Quality into production to drive cost-effective innovation

by cyb2025

EDUARD CAYÓN
VP Audit Services, Rephine Ltd, Barcelona, Spain

ABSTRACT

As innovative biotech products and personalised therapies progress from lab-based scientific research to human clinical trials and full-scale production, companies are being forced to adapt their Quality processes. Dr. Eduard Cayón of Rephine/ TDV explains how reimagining Quality processes can help get these potentially expensive emerging therapies to market.

As the emphasis of new drug development gravitates away from chemical synthesis towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. For young biotechs, scaling up production brings green-field challenges, while for more established pharma a shift may be required to ensure that facilities are optimised for new ways of working.

ABOUT THE AUTHOR

Dr. Eduard Cayón is an experienced pharmaceutical industry consultant at bespoke technology and manufacturing supply chain compliance consultancy TDV. He is also the founding partner, VP and a director of pharma auditing organisation Asociación Fórum Auditorías (AFA) in Barcelona. The two organisations recently merged with Rephine Ltd, to create the leading global force in GMP audit services.
https://www.rephine.com/

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