Contained Manufacturing Facility for the Development and Manufacturing of Highly Potent Molecules
Over recent years, the pharmaceutical industry has seen a significant increase in R&D focus on specialized medicines with oncology being a particular driver within this.
As the biological activity and specificity of the API increases, dosage strengths decrease leading to an increased potency of the API itself in terms of the occupational handling for drug product manufacture. With such specialized therapies and highly potent API comes a need for specialist handling with a move away from traditional personal protective equipment (PPE) towards technology based contained engineering solutions.
PCI’s award winning contained manufacturing facility ensures reliable quality and delivery performance, providing an innovative and agile relationship with our clients.
Continued investment maintains our leading position in the processing of highly potent molecules. In addition to existing contained equipment, our most recent investments include roller compaction technology in the form of a Gerteis Mini-Pactor and a fully contained Xcelodose® 600S micro-dosing system providing automated drug-in-capsule (DIC) for early stage development delivering a faster route to clinic for our clients.
Key capabilities and technologies within the contained manufacturing facility include:
- OEL down to 0.01μg/m3
- High shear mix granulator
- Contained roller compaction
- Contained Xcelodose® 600S technology
- Fluid bed drier
- Cone mill
- Blending mixer
- Tablet press
- Tablet coater
- Capsule filling
- Bottle and blister packaging