STABILITY STUDIES
Kymos 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. We have broad experience with the following stability testing services:
- ICH stability testing (long term, intermediate and accelerated stability)
- Ongoing stability studies and programs
- Preliminary stability studies for API and FDF
- Development & Validation of stability indicating methods
- Stress testing (light, pH, humidity, temperature, oxidation)
- ICH photostability testing of drug substances and products
- Determination of leachables migrated from packaging
- In-use stability studies and testing: multidose containers and parenteral solutions compatibility
- GMP stability storage
- Holding time studies for bulk products
- Temperature cycle test, freeze-thaw, transportation
- Full study management
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. Our walk-in climatic chambers have 100m3 of GMP stability storage capacity for the following climatic zones and conditions:
- Standard conditions (climatic zone II): 25ºC/60%RH; 30ºC/65%RH; 40ºC/75%RH
- Tropical conditions (climatic zone IVb): 30ºC / 75%RH
- Other conditions: 25ºC/40%RH; 30ºC/35%RH; 40ºC/NMT 25%RH
- Refrigerated conditions: 5ºC ± 3ºC
- Freezing conditions: – 20ºC ± 5ºC; – 80ºC ± 10ºC
- Semipermeable containers and personalized conditions on demand
