Summary: At our recent event in Garnet Valley, PA., our team presented a poster titled “Use of ASAPprime™ in a Pharmaceutical CDMO Space”, showcasing how stability assessment with advanced predictive stability assessment tools helps accelerate drug development timelines.
Poster authors Kyle Frey, Helen Baker, and Brad Rowe highlighted the impact of ASAPprime™ modeling in a contract development and manufacturing organization (CDMO) setting.
Read highlights from the poster below and download the poster to see additional findings.
How does ASAPprime™ work?
Traditional ICH stability studies can take months or even years to yield actionable data. ASAPprime™ offers a smarter, faster alternative—delivering precise long-term stability predictions in as little as 28 days.
The poster detailed how ASAPprime™ has been successfully applied across all development phases—from early formulation screening to post-registration and lifecycle management activities.
Key applications of ASAPprime™ include:
- Early identification of stability risks
- Comparative shelf-life analysis
- Packaging optimization (e.g., validating removal of desiccants without compromising stability)
- Mechanistic understanding of degradation pathways
- Support for regulatory submissions with FDA-accepted data
Why it matters: Real applications and benefits of ASAPprime™
In a competitive pharmaceutical landscape, speed and precision are critical. ASAPprime™ empowers development teams to make informed decisions faster, reduce unnecessary testing, and ensure product viability from benchtop to patient.
As a CDMO using ASAPprime™, we have been able to provide reliable, data-driven insights to support investment decisions:
Predicting 1-year shelf life (subsequently verified by real-time stability data) for various oral liquid, immediate-release tablets, and modified-release tablet formulations
Demonstrating that a novel formulation was three-times more stable than a marketed product of the same active pharmaceutical ingredient
Optimizing packaging configurations for cost savings
This approach is not one-size-fits-all: each study is tailored to the drug program, ensuring relevance and reliability throughout the development lifecycle.
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