GOOD MANUFACTURING PRACTICE (GMP)

Advanced therapy medicinal products (ATPs) are a particularly novel class of medicines which include somatic cell therapy, gene therapy and tissue engineered products. They represent a field with a constantly evolving regulatory landscape that scientists and regulators alike find challenging to navigate.

 

The recent regulatory initiatives from Hong Kong’s Department of Health imply a transformation of the requirements for ATP manufacturing and their application to human beings. Stem cell scientists should therefore be aware of the intricacies of PIC/S GMP implementation before initiating full-fledged translational programs, and also have at their disposal well trained technologists who will develop ATPs at different laboratories and institutions-be it hospitals, academia or industry in Hong Kong.

 

Biocline values the importance of ATP development in Hong Kong and have joint forces with world leaders in Qualification of Clean Rooms and Environmental Monitoring (European standards) to provide related training programs and consultancy services in Hong Kong and Big Bay Area.