Using Accelerated Stability Assessment Program (ASAP) to Shorten & Strengthen Your Product Development Process
The Accelerated Stability Assessment Program (ASAP) is a new approach to stability testing, intended to accurately quantify the sensitivity of a drug substance or a drug product in a very short time to both temperature and moisture. The ASAP approach is performed by very short-term exposure of the candidate drug substance or a solid drug product (e.g. up to 2 weeks) to a range of high temperatures and humidity within a DoE-like study design, and testing samples for assay and degradation products. The results are then fitted into the ASAP equation, linking degradation to moisture and temperature. Once data are modelled, it is possible to predict the stability of the drug substance or drug product at any time, temperature and relative humidity.
This webinar will focus on showing how the ASAP approach can very well fit into different stages of a product development, shortening product development time and strengthening relevant key decisions.
- Helping early candidate selection of moisture sensitive drug substance versions (to select the more stable and less moisture-sensitive version)
- Not only ranking developed formulations in order of stability, as traditional single stability condition approaches, but also accurately predicting the stability of the product at fixed expiry times
- Rapidly supporting pack selection on the basis of formulation moisture sensitivity
In addition ASAP data can also support preliminary clinical shelf-life setting in early development phases.
Dr. Piero De Filippis, Stability Manager, Pharmaceutical & Preclinical Development, Aptuit Center for Drug Discovery & Development, Verona – Italy
Piero De Filippis is currently Stability Manager, leading the Stability Team in the Pharmaceutical & Preclinical Development Department within the Aptuit Center for Drug Discovery & Development, in Verona – Italy. Key Team responsibilities include stability study design and management, plus stability data evaluation and reporting.
Dr. De Filippis graduated in 1979 in Pharmaceutical Chemistry & Technology at the Faculty of Pharmacy at the University of Bologna (Italy). He started his career at Glaxo R&D Centre in Verona, Italy becoming later Team Leader of the Stability & Physical Pharmacy Laboratory in the Pharmaceutical Technology Department.
During his 35 years of experience in the Pharmaceutical field, Dr. De Filippis has covered many roles in the stability and regulatory related areas. In these roles he supported the development progressions for stability of a very large number of compounds and products at the Verona R&D Centre, first as Glaxo-GlaxoSmithKline and then Aptuit, from early clinical phases up to late registration and market.
Who Should Attend?
- CMC Heads/Managers
- Project /Program leaders
- Lead Analysts
- Stability Managers and Specialists
- Regulatory Managers and Specialists
Aptuit LLC provides the most complete set of integrated early discovery to mid-phase drug development services in the Pharmaceutical industry including Drug Design & Discovery, API Development and Manufacture, Solid State Chemistry, CMC, and Preclinical and IND enabling GLP/GMP programs. Fully integrated drug discovery and development services are available from a single site at The Aptuit Center for Drug Discovery & Development in Verona, Italy. The company maintains resources around the world, with facilities in the US, UK and Italy. Aptuit LLC is partnered with Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors.
For more information about Aptuit, visit www.aptuit.com.