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Only Enavail can offer you a range of particle engineering systems with all of the factors important to your compound development: high bioavailability, highest available potency, gentle processing for labile compounds, and versatility for multiple routes of administration.
Enavail sets itself apart from other companies by specializing in just one thing: particle engineering for enhancing small molecule compounds, proteins, and peptides. Our range of services is designed to support your efforts from discovery through development and into the clinical pipeline.
Screening
We offer screening studies for discovery stage molecules and realize the high cost of your NCE’s. That’s why our discovery screening is designed to deliver you enhanced material while utilizing as little API as possible – even sub-milligram quantities. The Enavail process allows for fast throughput while still taking advantage of the entire suite of technology solutions. This results in rapid assessment and optimization of lead compounds, and allowing for effective lead compounds to move forward in development.
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GMP Clinical Batch Production
Upon achieving superior performing compounds using our particle engineering, Enavail can support your clinical efforts with our state of the art cGMP facilities. We offer clinical batch production for compounds with application in pulmonary, parenteral, intranasal and oral delivery.
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Screening Process
- API Physico-chemical Characterization
- API solubility and stability in a variety of relevant solvents
- Morphology and surface area
- Process and Excipient Selection
- Rapid Freezing
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Controlled Precipitation
- Screening Production and Testing of Samples Using Processes
- Potency, morphology, and supersaturation
- Analytical Characterization
- USP and custom dissolution testing
- Animal model testing (PK Studies)
- Analytical development
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Development and Manufacturing
- Optimization of Drug Potency and Bioavailability
- cGMP Clinical Batch Manufacturing (Q1 2010)
- Full Analytical Testing for Clinical Batch Release
- Identification – FTIR
- Potency/Impurities/Related Substance – HPLC
- ICH Stability Protocols
- Residual Solvents – GC
- Loss on Drying
- Microbial Limits
- Specific Drug Monograph Custom Testing
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