LuinaBio offers customized stability assessment services. Our program contains a documented, on-going testing regiment designed to monitor the stability of key characteristics needed to confirm storage conditions, expiration and retest dates for APIs, isolated process intermediates and formulated drug products. This includes a formal stability protocol design, chromatographic analysis, wet chemistry and dissolution testing performed with validated and stability indicating methods.
Our program assesses any existing stability data from previous studies to determine the number of commercial production batches needed for the stability monitoring program. Typically, three commercial batches are required and used for stability purposes, and then one batch per year thereafter for each API to confirm ongoing stability.
Stability samples are stored in containers that simulate market use. If an intermediate is to be transferred outside of the control of LuinaBio’s material management system, we can ensure that a supported expiry or retest date is assigned and the stability information is available to the client.
LuinaBio’s stability facilities are licensed for storage of controlled substances but we can also coordinate with qualified third-party storage sites. Our on-site facilities provide off the floor storage under conditions that have no adverse effect on their quality and our first-in/first-out design ensures a controlled rotation of stock.
Qualified stability chambers, consistent with the ICH guidelines on stability, are available on site at the following temperatures:
- -80 °C
- -20 °C
- 4-8 °C
- 25 °C