Quotient Sciences offers FreeThink ASAPprime® software as an add-on service to drug programs to rapidly predict long-term product shelf-life. In this Q&A with Helen Baker, Director of Pharmaceutical Sciences, we talk more about how the software works at different stages of the development process and how customers can benefit from adding on analysis with ASAPprime® software to their next drug program with Quotient Sciences.
What is ASAPprime® software?
ASAPprime® software is developed by FreeThink, and Quotient Sciences have licensed it for use. A dedicated stability lab to support programs and products utilizing this software has been set up at Quotient Sciences to enable us to support clients in rapidly predicting the long term shelf life of products in development.
At what stage of development should the ASAPprime® software be used?
Customers can choose when and how much use they want to implement ASAP stability, from use-as-needed to supporting product development as a parallel tool used in tandem throughout any given phase. We can leverage the modelling in a new or existing program to help at various points:
- In initial stages of development, when there is little or no prior knowledge of stability behavior
- Prototype assessment or side-by-side comparison of new with existing products
- In reformulation into new dosage types, validate new API manufacturing processes and identify potential risks in new equipment or material supplier changes
- In the investigation into failed batches or out of spec trends alongside projects in real-time or retrospectively
- In commercialized products, to assess the impact of different packaging configurations, API or excipient changes
How does ASAPprime® work?
ASAPprime® requires that samples are set down at specific temperature and humidity settings, and analyzed at pre-determined time points. Typically, a study looking at a single entity would require 8-19 conditions over a period of about 28 days. A scouting study may be required before starting to determine the right conditions for the study (very degraded samples cannot be used and it is critical for the modeling to know the isoconversion times. For shelf-life prediction, it is essential that all conditions are as close to possible at the isoconversion limit).
The isoconversion point is the time a certain degradation product, total degradants, potency, or other critical parameter is needed to reach the specification limit. This governs shelf life, or the point at which the product is outside of acceptance limits. Interconversion can be considered “the edge of failure” for a particular product. Rather than follow the traditional approach of using fixed time points whilst monitoring the degradant level, the model looks at variable times at each condition required to hit the specification limit.
How long will ASAPprime® take to generate stability data for my product?
Study timelines typically range from as little as 7 and up to 28 days. Studies using the ASAPprime® software will vary depending on:
- Scope of assessment (such as comparing formulation prototypes or packaging options)
- Availability of prior data and intended specification limit (e.g. degradant, potency, slowed dissolution release, total moisture uptake)
- Intrinsic drug stability or instability
Contact us today for more information about how we can help you leverage ASAPprime® software for your drug program.
