Clinical Trial Manufacturing
Manufacturing of injectable microparticles for clinical trials
SurModics’ manufacturing competencies include the ability to manufacture clinical trial materials for a broad range of parenteral, drug delivery dosage forms such as microparticles, nanoparticles, resorbable and non-resorbable implants, lipid nanoparticles, polymeric nanoparticles, liposomes, long-acting hydrophobic salts and drug-eluting devices. Manufacturing activities can come from client-funded, development programs or through product technical transfers from third parties.
SurModics has extensive experience producing batches for Phase I through Phase III clinical trials. Products range from terminally sterilized resorbable implants to aseptically manufactured microparticle and liposome formulations. Clinical trial manufacturing production batches range from grams to 75 kilograms per lot.
In accordance with FDA, EU and other regulatory guidelines, SurModics’ understanding of pharmaceutical processing, melt-extrusion processing, microparticle/powder technology, emulsion science, fluid dynamics, and various product isolation techniques enables SurModics to bring in client processes, analytical methods and develop strategies for clinical trial material production. These activities can involve dedicated process development/scale up pilot equipment and lab-scale-to-pilot process development and control. Process control can start with batch sizes as small as 10s of grams of material.
SurModics’ GMP clinical trial manufacturing facilities include:
- About 650 sq. ft. of classified area within existing suites
- Class 100 to 100,000, temperature and RH controlled
- Quarantine and storage areas for each suite
- Qualified systems and utilities
- Qualified environmental monitoring
- Qualified refrigerators and freezers
Typical clean room suite