Juniper Pharma Services, a subsidiary of Juniper Pharmaceuticals, Inc., 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 organisation (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 major multi-partner programme 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.
Dr Claire Madden-Smith, Senior Vice President at Juniper Pharma Services, said: “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.”
“Innovation and flexibility is at the heart of the AMSCI project. The work we have done 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 optimisation required versus traditional development platforms, it allows for quicker scale-up from animal studies to human-ready batches.
Paul Thorning, CEO at CrystecPharma, said: “I am very proud of the work CrystecPharma and Juniper Pharma Services, along with the rest of the consortium partners, have undertaken. 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.”
“We also have to remember that this has never been done before. Our equipment combined with Juniper’s expertise is the only project of its type in the world and is truly innovative in terms of using modified supercritical fluid technology (mSAS) for the manufacture of smarter, higher quality pharmaceutical products.”
“The sum of the consortium is certainly stronger than its individual parts and the AMSCI is reinforcing the UK’s position as the best in the world at drug development innovation.”