Industry Collaboration Results in Newly Patented Technology that Helps
Drug Companies Comply with Latest Regulatory "Quality by Design" Initiatives
Burlington, Mass - Aspen Technology, Inc. (NASDAQ: AZPN), a leading provider of
software and services to the process industries, today announced
that GlaxoSmithKline, AstraZeneca and other pharmaceutical industry
leaders are reducing their research and development time and costs
using newly patented technology that is part of
AspenTech’saspenONE Process Development for Pharmaceuticals
- The solubility modeling technology – developed in
collaboration with pharmaceutical companies – provides
"Quality by Design" (QbD) capabilities that help manufacturers
comply with the latest industry regulatory initiatives.
- Using the aspenONE software, GSK is able to throroughly
understand the solubility properties of new chemical entities (NCE)
to assess more quickly risks and improve confidence during the
development of new pharmaceuticals. As part of the aspenONE®
for Pharmaceuticals suite, drug companies can also ensure a highly
repeatable manufacturing process.
- This simulation modeling technology optimizes crystallization
design workflow by allowing pharmaceutical companies to:
- Save time and money. By quickly evaluating the solubility
properties of a NCE, laboratories can focus precious
experimentation efforts in areas that have a high likelihood of
success based on the simulation results. Drug solubility is a
critical factor in determining efficient manufacturing processes
for a candidate drug.
- Conduct clinical trials earlier. Begin process development
activities sooner using the predictive modeling capabilities of the
software to quickly design optimized manufacturing and purification
- Reduce cost of goods and supply disruptions. Enable informed
design of the final Active Pharmaceutical Ingredient (API)
manufacturing processes so they are optimized to produce less waste
and higher yield.
- AspenTech received the patent for creating a nonrandom
two-liquid segment activity coefficient (NRTL-SAC) model that
provides a simple yet scientific basis to predict drug solubility.
This is the latest of dozens of patents issued to AspenTech for
innovative solutions in process optimization.
Stephen Carino, Investigator – Solid Form Sciences Group,
"Screening for crystalline forms is an essential component in
pharmaceutical drug development. In our high-throughput screening
workflow, we have utilized NRTL-SAC in Aspen Properties to predict
the equilibrium solubility of the drug in single- and
multi-component solvent systems. The predicted solubility values
are used in selecting an appropriate set of solvent systems that
are explicitly unique for each of the crystallization modes. This
rational solvent selection coupled with the systematic screening
approach has allowed us to assess risk around solid forms and
improve our confidence in the robustness of the API processes."
Jamie Hintlian, Vice President of Pharmaceuticals, Aspen
"Solubility is essential in evaluating drug candidacy and
manufacturability. Without predictive tools, many organizations are
forced to fly blind when it comes to this mission-critical
information. Solubility modeling and prediction adds value by
enabling greater efficiencies, better decision making, faster
process development, and better process performance. For the
pharmaceutical industry leaders involved in its development, and
other potential users, this is a powerful screening protocol for
the drug development process."
AspenTech is a leading supplier of software that optimizes process
manufacturing – for energy, chemicals, pharmaceuticals,
engineering and construction, and other industries that manufacture
and produce products from a chemical process. With integrated
aspenONE solutions, process manufacturers can implement best
practices for optimizing their engineering, manufacturing and
supply chain operations. As a result, AspenTech customers are
better able to increase capacity, improve margins, reduce costs and
become more energy efficient. To see how the world’s leading
process manufacturers rely on AspenTech to achieve their
operational excellence goals, visit www.aspentech.com.