Accelerated Stability Assessment Programme (ASAP)

Using the Amebis System when performing an ASAP Study

Amebis SystemASAP is an accelerated aging process that provides faster and more accurate prediction for drug substance and drug product shelf-life

Process

  1. Aging Process - test material exposed to a range of environmental conditions. Amebis system generates, accurately measures and records the environmental aging conditions. Operating range 5-80C / 0-95%RH
  2. Analysis of aged test material using stability indicating method
  3. Build stability predictive model - ASAPprime® Software is the only commercially available software package to quickly and accurately determine drug substance and product shelf-life based on ASAP.

ASAPprime softwareThe Amebis system performs the aging and the ASAPprime® software builds the stability predictive model. We can also perform on your behalf any or all of the stages for an ASAP study at our laboratories.

Contact us for pricing, available services and further information. On-site ASAP presentations and case studies available.

Advantages

  • Faster enables prediction of drug substance and drug product shelf-life more quickly and accurately
  • Accurate Data - accurate aging data for a more accurate stability predictive model
  • Flexibility - multiple aging environmental conditions can be easily generated, measured and recorded with minimal space requirements
  • Better Decisions - allows for better decisions earlier in the development process thereby preventing costly reformulations and other changes. Makes regulatory packages more robust by providing scientific rationale for decisions
  • Better Choices - provides a robust, science-based argument for choosing the optimal combination of packaging, formulation, ingredient supplier and manufacturing process without the need for repeated and lengthy laboratory studies

Applications & Benefits

Early Clinical Trials

  • Amebis System ConsumablesSupport Clinical Use Period assignments
  • Determine retest periods for API, starting materials & analytical standards

During Development

  • Predict stability for changes in: Formulations/processes, Synthetic routes & Packaging
  • Determine retest periods for API, comparator, reference standards & starting materials
  • Faster shelf-life determination

Post-Approval

  • Justify changes that will not affect stability
  • Justify acceptance of excursions during storage/shipments
  • Accurately assess stability and shelf-life variation between product lots

At Registration

  • faster into clinics for NCEs
  • Eliminate packaging screening
  • Select optimal bottles (capsule/tablet counts and desiccants), blisters and drums
  • Allow for zone packaging selection
  • Better insight into packaging, formulation and process choices
  • Supportive data or alternative to traditional stability to minimise stability commitments
  • Support QbD filings