Juniper Pharma Services has reached a key milestone in its work with CrystecPharma and the Advanced Manufacturing Supply Chain Initiative (AMSCI) to create a new platform to accelerate drug development.
The contract development and manufacturing organization (CDMO) now has CrystecPharma’s supercritical fluid technology platform on-site. Validation is underway to enable its use in the production of clinical trial materials.
This multi-partner program was initiated to move medicines from research to the market with increased speed and quality. Two years since the AMSCI was announced, the UK-based consortium expects to be manufacturing drug substance to GMP standard at Juniper’s facility in Nottingham by the end of the summer.
“Our progress on the AMSCI project with CrystecPharma and other consortium partners brings us within reach of a commercially viable platform for the advanced manufacturing of next generation medicines,” Dr. Claire Madden-Smith, senior vice-president at Juniper Pharma Services, said. “Innovation and flexibility is at the heart of the AMSCI project. The work we have carried out with CrystecPharma illustrates the value of supply chain collaboration in enhancing medicine manufacturing and ultimately benefiting patients around the world.”
Aimed at drug developers with combination products and compounds that are difficult to crystallise, supercritical fluid technology has been developed to produce better quality drug substances. With less optimization required versus traditional development platforms, it allows for quicker scale-up from animal studies to human-ready batches.
“I am very proud of the work CrystecPharma and Juniper Pharma Services, along with the rest of the consortium partners, have undertaken,” Paul Thorning, CEO at CrystecPharma, said. “Moving from the establishment of the collaboration to the production of GMP materials in just 18 months will be quite an achievement, hence the interest we are seeing from many drug developers with a portfolio of relevant compounds.”