Stability

Storage is key

Reliable storage of samples at accurately controlled and documented climate conditions is key to the performance of stability studies. After logging,
stability samples at PROXY are stored at relevant ICH-compliant conditions (25 °C / 60 % RH, 30 °C / 65 % RH and 40 °C / 75 % RH). Biological products
can also be stored at -80 °C, -20 °C, 5 °C and 15 °C. Every climate controlled facility is monitored continuously and an alarm system ensures that during the entire span of
the study, temperature and humidity conditions are maintained within the specifications detailed in the ICH-guidelines.

Stability protocol
In close collaboration with the client a stability protocol will be drafted prior to the initiation of the stability study, which describes shipment and storage
conditions of study samples, responsible key persons, testing program, reporting conditions and timelines. After each time-point, data are statistically
evaluated to ensure that any trend in the analytical data is recognized timely.

Evaluation and documentation
Prior to the initiation of stability studies, PROXY can assist you in evaluating and documenting the “stability indicating power” of your analytical methods.
If needed, further method development and validation can also be provided or supported. Degradation studies, comprising different degradation techniques
and pathways (e.g. acid-, base-, light-, humidity and heat treatment), enable a complete analytical package acceptable to regulatory authorities.

Critical issue
Stability studies are becoming increasingly important in the (bio)pharmaceutical development and registration process, and soon will be extended to the postmarketing period when the “On going Stability”-addition to the EU guide to Good Manufacturing Practice will be approved. For every (bio)pharmaceutical production facility the stability burden on the QC-department will become critical for the capacity of equipment, storage space and human resources. With our experience and facilities, PROXY is able to take care of your stability studies efficiently and cost-effectively.

Storage facilities

  • -80 °C
  • -20 ± 3 °C
  • 5 ± 3 °C
  • 15 ± 3 °C
  • 25 ± 2 °C / 60 ± 5 % RH
  • 30 ± 2 °C / 65 ± 5 % RH
  • 40 ± 2 °C / 75 ± 5 % RH

Additional climate chambers are available for other temperature / humidity combinations.

Light source for photo stability studies

  • Type: Suntest CPS
  • Light source: 1100 Watt air cooled Xenon arc lamp
  • Total exposure area: 560 cm2