The global cell therapy industry continues to rise during the second and third quarters of 2012.

During Q2-Q3 2012, the cell therapy industry benefited from a number of positive external influences including advantageous changes to future FDA regulation, but stock market activity was highly mixed. The FDA approved two more products and an appreciable number of public-company-sponsored clinical trials are progressing through phases 1-3.

The simplex algorithm for the rapid identification of operating conditions during early bioprocess development: case studies in FAb' precipitation and multimodal chromatography.

This study describes a data-driven algorithm as a rapid alternative to conventional Design of Experiments (DoE) approaches for identifying feasible operating conditions during early bioprocess development. In general, DoE methods involve fitting regression models to experimental data, but if model fitness is inadequate then further experimentation is required to gain more confidence in the location of an optimum. This can be undesirable during very early process development when feedstock is in limited supply and especially if a significant percentage of the tested conditions are ultimately found to be sub-optimal.

Principal component score modeling for the rapid description of chromatographic separations.

This paper describes the use of Principal Component Analysis (PCA) as a tool for modeling chromatographic separations. PCA is an analytical technique developed to extract key information out of large data sets and to develop relationships and correlations. The basis of the proposed model is the use of PCA to correlate experimental chromatographic data across different process variables or scales.