Kymos Group has two EMA and FDA inspected EU sites providing GMP-certified ICH stability and ongoing stability studies of small or large molecules for global pharma clients, including pharma innovators and generic manufacturers. We analyze a wide range of finished products from tablets, capsules and ampoules to topical products, injectables and powders.
Our two EU sites have walk-in climatic chambers with a combined storage capacity of 100m3 for ICH climatic zones II, IVb plus additional conditions as well as fully equipped laboratories for the development, validation and testing of both small molecules and biologics.
We use comprehensive, fit for purpose method validation designs according to relevant ICH guidelines, US and EU recommendations as well as clients’ requirements.
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Our Solution for Stability Studies
All our stability laboratories and programs are managed by LIMS LabWare®, chambers are monitored through SCADA systems, and backup chambers are available for disaster recovery plan.
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Related services to Stability Studies
Extractables and Leachables
Semi-quantitative screening for both volatile, semi-volatile and non-volatile organic compounds.
Method Development, Validation and Transfer
Development and validation of analytical methods for excipients, APIs, intermediate products and finished products.
Microbiology
Laboratory including cleanroom with airlock technology and HEPA filters for testing of sterile and non-sterile APIs and drug products.
Quality Control of Biologics and Biosimilars
Complex characterization projects for innovative biologics and comparison of biosimilars.
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