How FreeThink’s predictive stability software compares across the stability modeling market
Predictive stability modeling helps pharmaceutical development teams use scientifically designed accelerated stability studies to determine shelf life, establish packaging, make formulation decisions, and move regulatory filings forward faster.
ASAPprime® is FreeThink Technologies’ predictive stability modeling software, based on the Accelerated Stability Assessment Program (ASAP). It uses statistically designed short-term studies that vary temperature and, where appropriate, relative humidity. The data are analyzed based on isoconversion principles and Arrhenius kinetics, with humidity corrections as needed, to generate long-term shelf-life projections from short-term accelerated stability studies. FreeThink develops and licenses ASAPprime® and provides the scientific, technical, and regulatory documentation needed to apply the software in global regulatory submissions.
Predictive stability software options currently include five broad approaches, as shown below:
| Approach | What it is | Best-fit use | Comments |
| ASAPprime® | Statistical fitting based on isoconversion modeling coupled with either a moisture-modified Arrhenius equation (solids) or the standard Arrhenius equation (liquids) | Small and large-molecule (biologics) drugs and drug products, solution and solid-state, chemical and physical stability; excursions; packaging selection. | Widely used across the pharmaceutical industry with a proven track record and regulatory filing history. Validated software for GMP use. |
| In-house scripts | Custom R, SAS, MATLAB, Python or Excel codes incorporating statistics for Arrhenius modeling. | Large pharma with dedicated statisticians. | No packaging database, software not validated, no support or filing precedent. |
| Enterprise analytical platforms | Suites (e.g. ACD/Labs Luminata) that fold Arrhenius calculations into data processing. | Organizations wanting stability analysis tied to instruments. | Better suited to standard stability and QC applications, statistics limited and not specifically suited for accelerated stability modeling. |
| Advanced Kinetic Modeling (AKM) | First-order and multi-step kinetic models for solution-phase degradation. | Biologics, vaccines and other complex modalities. | Primarily suited to solution-phase stability modeling and may require careful model selection to avoid overfitting when data are limited; no regulatory track record. |
| Emerging AI / ML platforms | Models trained on historical datasets. | Well-established commercial batches where large amounts of historical data are available. | Not able to determine stability for new products; better suited for quality control than determining stability. |
What sets ASAPprime®apart
- Well-established history. ASAPprime® has become the industry standard. It has been shown to accurately predict the shelf life of thousands of drug products over many years of studies by numerous companies. These predictions extend across many types of drug products including small molecules and biologics, solutions and solids, with stability limitations such as degradation product formation, assay loss, dissolution change, and appearance change.
- Filing precedent. ASAPprime® has a proven regulatory record, with hundreds of successful filings including NDAs, INDs/IMPDs and post-approval applications globally.
- Packaging intelligence. Built-in packaging modeling with real packaging configurations enables shelf-life projections to compare and select appropriate container closure systems.
- Scientific experimental design. Experimental protocols are designed using the included subprogram ASAPdesign™ based on specific drug product information.
- End-to-end support. FreeThink provides training, consulting and regulatory documentation support to help users apply the ASAP science effectively, not just to use the software.
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About FreeThink Technologies
FreeThink Technologies is a contract research organization specializing in accelerated drug development services. Our Molecule-to-Clinic platform integrates API development, preclinical development, clinical manufacturing, and regulatory strategy to help pharmaceutical companies advance drug candidates efficiently.
Founded in 2011, FreeThink’s Branford, Connecticut laboratories conduct experimental work to help companies develop formulations, establish analytical methods, and solve complex problems. FreeThink also develops and licenses ASAPprime®, the leading stability software package for determining shelf life under highly accelerated conditions.
Contact: info@freethinktech.com | +1 860 237 5800 | freethinktech.com
Services: API Development | Drug Development Services | Preclinical Development | Clinical Manufacturing | Pharmaceutical Research | GMP Manufacturing