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 services:

Climatic Chambers for Stability studies
  • ICH stability testing (long term, intermediate and accelerated)
  • Ongoing stability programs
  • Preliminary stability studies for API and FDF
  • Development & Validation of stability indicating methods
  • Stress testing (light, pH, humidity, temperature, oxidation)
  • Photostability of drug substances and products
  • Determination of leachables migrated from packaging
  • In-use stability studies: multidose containers and parenteral solutions compatibility
  • Holding time studies for bulk products
  • Temperature cycle test, freeze-thaw, transportation
  • Full study management
Climatic chambers for stabilty studies

All stability 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 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
Climatic chambers for stabilty studies

Related Services to Stability Studies

Method Development, Validation and Transfer

Development and validation of analytical methods for excipients, APIs, intermediate products and finished products.

Batch Testing and Batch Release

KYMOS and PHARMAPROGRESS are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

Quality Control of Small Molecules

Analytical tests for APIs, excipients, intermediate products, finished products, packaging materials and process environment samples.

Quality Control of Biologics and Biosimilars

Complex characterization projects for innovative biologics and comparison of biosimilars.

Extractables and Leachables

Semi-quantitative screening for both volatile, semi-volatile and non-volatile organic compounds.

Microbiology

Laboratory including cleanroom with airlock technology and HEPA filters for testing of sterile and non-sterile APIs and drug products.

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EU Sites

Kymos Group

Barcelona
Spain

Prolytic

Frankfurt
Germany

Pharmaprogress

Ancona
Italy

EU Offices

Paris
France

Basel
Switzerland

Milano
Italy