Stability Studies

Purpose of stability testing is to understand how a biopharmaceutical product changes over a defined period of time under certain conditions (temperature, air humidity, light). The shelf-life and the recommended storage conditions for a biopharmaceutical product among other information can be derived from the results.
JAFRAL can provide template of stability program, but then every stability study is treated as a customised order. Depending upon the product and the project phase, you will require a coordinated range of services over a wide range of climatic conditions as well as physical, chemical and microbiological tests.

JAFRAL offers long-term and short-term stability testing for biopharmaceutical products.
Stability Testing program follows the ICH Final Guideline on Stability Testing of Biotechnological/Biological Products and FDA Guidance for Industry Q1A (R2) Stability Testing of New Drug Substances and Products.

Testing can be performed on:

  • Research/ Process development material
  • Cell/Virus banks,
  • Drug substances
  • Drug products/Placebo
  • Various intermediates

Example of temperature conditions:

  • -80±10°C
  • -20±5°C
  • 5±3°C
  • 25±5°C
  • Accelerated conditions (e.g. 40±5°C)
    Control of relative humidity can be included if needed.

PRODUCT DEVELOPMENT PROCESS

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2018-11-05T12:46:19+00:00