Helps new molecules move into Phase 1 clinical trials more quickly
Juniper Pharma Services has reinforced its early stage capsule filling expertise with the expansion of its Xcelodose powder micro-dosing system as part of its suite of GMP capabilities.
The move by the Nottingham, UK-based contract development and manufacturing organisation (CDMO) follows demand from its clients to develop the technique to complement its development services and help get new molecules to Phase I clinical trials quicker.
Xcelodose enables Juniper Pharma Services to accurately fill API directly into capsules in an efficient and automated manner primarily to support first-in-human studies, reduce formulation requirements and minimise drug substance wastage.
Claire Madden-Smith, Senior VP at Juniper Pharma Services, said: 'We have focused on having a broad range of development capabilities to enable our clients to rapidly access the most appropriate solution to meet their need. The increased usage of Xcelodose is a natural expansion of our manufacturing services.
'The technique simply allows us to make and supply batches of the drug in capsules for clinic in a much more precise and economical manner.'
Xcelodose provides the automated processing of API directly into capsules at very low doses and is suitable for highly soluble products and potent molecules. The system removes the need for complex formulation development and allows data on a compound to be developed in a cost-effective way.
Juniper has well-established GMP clinical manufacturing capabilities covering topical and oral dosage form products, including the supply of potent compounds and controlled drugs. Since 1997, the CDMO has built a strong reputation in materials characterisation, formulation analysis and IP consultancy.