Friday, August 19, 2022

Stability studies moved to new premises

Václav Janda

Stability Manager

In the past months, oncomed has moved the premises for stability studies to a new building, which has significantly increased the storage capacity. However, this step brings many other advantages for both current and new customers and we would like to share them with you in this article.

Stability samples storage and testing is an important part of drug development. It is performed to determine how the quality of a medicinal substance or medicinal product changes over time under the influence of environmental factors such as temperature, humidity and light.

Outsourcing stability studies is an advantageous solution for pharmaceutical companies – outsourcing these routine but vital studies to experts with established capacity reduces costs and allows the companies to focus on research and development of new drugs.

Our service includes registration and ongoing stability studies according to ICH Q1A(R2) requirements, photostability studies according to ICH Q1B, infusion stability studies, transport studies and sample storage.

By moving the stability studies to the new premises, our storage capacities have increased significantly:

  • 25°C/60 % RH: increase by 85 %
  • 30°C/65 % RH: increase by 100 %
  • 2–8 °C: increase by 35 % with the possibility of further expansion

Another benefit of the relocation is the fact that now all the stability samples are stored in one place. Additionally, there is an option to add additional stability chambers for new stability conditions if needed. In addition, separate premises outside the production building guarantee better control of the access into individual rooms and chambers.

The construction of the new stability rooms is better than the previous one – insulation of the walls of the rooms guarantees lower energy consumption, better homogeneity of climatic conditions is ensured thanks to perforated shelves.

As it is clear from the above, many aspects had to be taken into account during the relocation of the installation of the stability studies storage. Although this step required a significant investment, we can now offer higher storage capacities and effective stability testing, and ensure the best possible quality of service for all our customers.

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