Handling Highly Potent Compounds Presents Unique Challenges
Highly potent compounds serve an increasingly significant role in numerous R&D landscapes and pharmaceutical intensive medical treatments, including oncology, atrial fibrillation, osteoporosis. To produce these products, a thorough process of product risk analysis is required in order to maintain a consistent manufacturing balance between production scale, market distribution and demand requirements.
Only a team like Adare, with an in-depth knowledge of the risks involved and a fully realized strategy for containment, can meet the challenges of high potency formulation and manufacturing.
Our experience with highly potent compounds allows us to offer high potency handling from 1 mcg/m3 and above at both pilot & manufacturing scales, subject to safety/facility assessment.
We utilize this experience to streamline the development of flexible manufacturing processes of highly potent compounds at every scale, from clinical trial materials through commercial product operations.
Adare’s global network of facilities includes dedicated, engineered manufacturing and development areas held to the highest standards of quality, such as our highly potent suite.
Highly Potent Suite
Adare’s Highly Potent Compound Contract Manufacturing Suite is a facility featuring 1000 sq. ft of readily available, hazard-certified production space.
Key service equipment and setups in the suite include a large scale Roller Compactor, Milling Room, Bin Blender, and Tablet Press, as well as ingress and egress airlocks with enhanced personnel controls. Manufacturing assessments verify each highly potent compound’s level of toxicity, potential personnel and facility exposure limitations.
This suite leverages the internal know-how and capabilities of our global product development and manufacturing teams. The expert personnel leading this suite contribute an average of 20 years practical experience to every project. Each team member prioritizes the safety and well-being, OEL guidelines, effluent containment practices, responsible air emissions, and sanctioned waste removal needed in order to best serve our pharmaceutical clients.
Adare’s Highly Potent Suite includes:
- Milling Room
- Roller Compactor
- Bin Blender
- Tablet Press
- IMA Synthesis 500
- High Potent Airlocks Locker room
- Material Airlock