Austin, TX – May 22, 2009 – SACHEM Senior Biochemist, Dr. C. Patrick McAtee published his article “A proposal for Proteomics: Is there a fit for QbD,” in the May issue of PharmaQbD. In his article, Dr. Patrick McAtee proposes a new approach to application for Quality by Design (QbD) to biopharmaceutical design and production realization utilizing a two dimensional (2D) Proteomic approach.
Quality by Design (QbD) is an innovative approach to drug development. It is a systematic process to build quality into a product from inception to final outpout and requires getting the product, process and manufacturing “right the first time.” In drug development, QbD programs can improve understanding of the product, reduce risk and increase regulatory flexibility. Implementation of this approach in early product development and characterization can address critical parameters affecting product heterogeneity.
Dr.Pat McAtee’s proposed approach for QbD to biopharmaceutical design and production highlights IsolisTM, SACHEM’s innovativedisplacement technology which can be used as the first dimension of a two dimensional rapid separation approach. Comparison of a product’s 2D “fingerprint” from one manufacturing step to the next allows the direct measurement of the effectiveness of that process step. However, these proteomic fingerprints can also be applicable to early and late stage clinical information in that they offer the potential to align and correlate both upstream and downstream variation effects. The incorporation of SACHEM’s novel proteomics approach into the manufacturing process yields a dynamic system in which input and endpoint responses may be correlated with confidence. According to McAtee, “SACHEM’s displacement technology combined 2D UPLC fingerprints brings a newer, more complete picture that can truly be enabling.”
SACHEM, Inc delivers highly pure, precise and innovative chemical solutions designed to solve the most demanding and challenging applications. For over 50 years SACHEM has provided chemical solutions and services to customers in key markets including electronics, advanced ceramics, biotechnology,starch modification, polymers, catalysts, pharmaceutical and agricultural chemicals. Based in Austin, Texas, SACHEM’s expanding worldwide operations include manufacturing and research facilities in North America, Europe and Asia with a global service network and presence spanning over 30 countries.
