AcuraBio’s customized stability studies and assessment services include documented, ongoing testing regimens designed to monitor the stability of key characteristics needed to confirm storage conditions, expiration, and retest dates for cell banks, Drug Substance/APIs, isolated process intermediates, and formulated drug products. This includes a formal approved stability protocol with agreed test methods.
We’re as passionate about the science behind your project as we are about the success of it. For example, our program assesses any existing stability data from previous studies to determine the number of commercial production batches recommended 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 commercial Drug Substance/API to confirm ongoing stability.
Cell Bank Stability Studies and More
For cell banks, process development, and clinical trial products, a stability protocol is designed in conjunction with the client to ensure the stability indicating parameters are analyzed. Stability samples are stored in containers that simulate the product packaging configuration. If an intermediate is to be transferred outside of the control of AcuraBio’s material management system, we can ensure that a supported expiration or retest date is assigned and the stability information is available to the client.
AcuraBio’s stability facilities are licensed for storage of controlled substances and our on-site facilities provide a wide range of stability trial conditions. This enables us to offer a stability program to suit client requirements ranging from short-term, accelerated stability to long-term clinical stability study programs. As a GMP facility, our stability programs are executed in accordance with ICH guidelines.
