Stability Studies for All Phases of The Drug Development Cycle Brochure

Solvias AGRömerpark 24303 KaiseraugstSwitzerlandTel. +41 61 845 60 00Fax +41 61 845 69 00info@solvias.comwww.solvias.com Solvias – your partner for comprehensive stability servicesFeatures• Wide storage capacity for all climate zones according to ICH guidelines and other storage conditions upon request• Fully GMP qualified• 24/7 monitoring and alert system enablingsecure and controlled environment• Emergency power supply• Back-up cabinets for complete sample retrieval• Disaster recovery plan in place• Labware LIMS (CFR 21 part 11 compliant) for professional management and data handling• Know-how and experience to deal with unexpected situations such as new degradation products, out of trend results etc...Our FacilitiesNEW Walk-in Chambers5°C 25°C/60% r.H. 50 m2 total storage capacity/walk-in chamberClimate Cabinets5°C25°C/60% r.H.30°C/65% r.H. and 30°C/75% r.H.40°C/75% r.H.-20°C-80°COther storage conditions available on request.Analytical Solutions/SpecialitiesMinimum Time PeriodStorage ConditionsType of StudyAcceleratedIntermediateLong term40 ± 2 °C / 75% r.H. ± 5 % r.H.30 ± 2 °C / 65 % r.H. ± 5 % r.H.25 ± 2 °C / 60 % r.H. ± 5 % r.H. or30 ± 2 °C / 65 % r.H. ± 5 % r.H.6 months6 months12 monthsStandard Storage Conditions Climate Zones I and IIStress Testsof APIsStability TestingPreformulationStress Testsof Scale-upsStress- and Long Term Tests forRegistrationFollow-upStability TestingOn-goingStability TestsStability Studies for All Phases of The Drug Development Cycle• Long-term stability studies according to ICH guidelines• On-going and follow-up stability studies• Comparability studies• Stress tests, forced degradation• Photostability testing according to ICH guidelines• In-use tests, freeze-thaw cycles• Excipient/API compatibility• Interaction studies with primary packaging• Stability protocols, reports and interim reports• Stability indicated method development and validation• Identification of unknown/new impuritiesAnalytical Power and Know-How to Cover Your Stability ProjectsFor Small Molecules• HPLC (numerous detectors), IEX, GC, TLC• HPLC-MS, GC-MS• Dissolution• Water (Karl-Fischer)• Titrations (e.g. assays)• Solid-state: XRPD, thermal methods• Viscosity/rheology• Microbiology• and many more...For Biopharmaceuticals• HPLC, IEX-HPLC, SEC-HPLC• HPLC-MS (ion trap, Q-TOF), MALDI-TOF/TOF• CE, cIEF, iCE280• Gel electrophoresis (PAGE, SDS-PAGE, IEF)• Peptide mapping (by LC-MS and/or LC-UV)• Oxidation, deamidation, charged variants• Glycosylation, sialylation• Assays (in-vitro, ELISA)• and many more...