GMP stability

Concept Life Sciences offers GMP pharmaceutical stability studies and ICH storage services to support development, commercial stability studies and sample batch release.

Concept’s stability team designs and delivers GMP stability programs for a comprehensive range of dosage forms, APIs and product types.

We provide efficient study management as well as a range of standard and bespoke storage conditions and testing capabilities to satisfy all regulatory criteria for short-term, real-time, accelerated or forced-degradation study requirements. We deliver data that enables our clients to establish product performance, required storage conditions, retest intervals and product shelf lives.

Our teams have the specialised knowledge required to develop and validate stability indicating methods and perform assay / impurity analysis as well as tests for dissolution, moisture, hardness and disintegration. Physical stability assessments (physical form, polymorph, particle size) are conducted alongside chemical stability determinations.

We offer a range of storage conditions including climatic chambers, refrigerated as well as frozen storage which are fully controlled and monitored, with back-up generator support.

GMP capabilities:

  • Actives, development formulations, finished products
  • R&D studies (ICH / GMP)
  • Stability-indicating assays, forced degradation
  • Protocol design
  • Sub-sampling and packaging (e.g. heat sealing)
  • Storage (-80ºC to 40ºC/75%RH, Ozone)
  • Analysis (physical / solid state / chemical)
  • Trend analysis
  • Reporting

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API release

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Pre-clinical formulation

Concept Life Sciences offers a comprehensive service for pre-formulation and formulation development plus GMP sample production for pre-clinical trial materials. We test and release formulations according to development specifications and produce samples under GMP conditions ready for transfer to study teams.

Clinical API manufacture

Concept Life Sciences delivers reliable, cost effective and timely supply of intermediates and APIs. Our technical and quality expertise makes us a leading strategic manufacturing partner. Concept can produce 1 to 10kg batches of API to GMP standards from our API manufacturing suite, located at our research and development facility.