The National Science Foundation (NSF) announced on March 14, 2008 the award of a Small Business Innovative Research (SBIR) Phase II grant to Blue Reference for the project entitled “Software Platform for Quality-by-Design Implementation.” The award is the outcome of an 18-month, national, two-phase proposal/research/review process with winners representing only about 3% of applicants. The $500,000 grant will be used to continue development and commercialization of Inference for QbD software for use in pharmaceutical development and manufacturing.

Phase II work on the Inference for QbD project is directed at three major development goals:

•  provide customers a reliable and systematic means to transform complex multivariate process data into process understanding;
• enable customers to decrease the time and cost required to achieve process understanding; and
• deliver to customers an effective vehicle for deploying and implementing Quality-by-Design practices in the multi-functional pharmaceutical company environment.