SCF Particle generation in compliance with GMP

摘要

Generation of various types of particles (nano-, micro-, neat or composite particles) for pharmaceutical applications is focusing significant R&D efforts worldwide. However, most works are completed on small-scale equipment, leading to attractive results that only demonstrate the process feasibility without any evaluation of scale-up issues. At the difference with most other industrial fields, manufacture of medicinal products is strictly submitted to drastic rules, defined by regulatory authorities, that can be gathered in a corpus called cGMP (current Good Manufacture Practice). Entering a new technology like SCF particle design is raising significant difficulties to convince the authority auditors of compliance with GMP. This implies a complete "revisit" of the process design and the integration of the basic concepts into a whole installation constructed and operated according to these stringent standards. At a moment when the situation is moving and the "pipe-line" is now rich of several formulations to be shortly introduced for pre-clinical or clinical trials, especially for manufacturing inhalable particles, enhanced bio-availability formulations, and stabilized bio-molecule composites, we briefly present how we are trying to improve the acceptance of SCF particle generation through the design and operation of SCF equipment installed in a compliant environment (clean room, effluent control, operator protection, etc.). We would conclude that, based on our growing experience in the field, clinical lots preparation and scale-up in compliance with GMP are accessible at present, and that several issues, which were regarded as bottlenecks, have been successfully addressed, making it possible to envisage a near commercial manufacture.