Our purification process development scientists work closely with your group to understand your needs and synchronize our efforts.  Our focus is on maximizing overall process yield and delivering high quality product using exceptional separation and analytical expertise to develop the most efficient purification process in a minimum amount of time.  Statistical design of experiments is used throughout the process development to systematically determine effect of process parameters.  We emphasize process integration from fermentation through downstream purification to ensure that the best process is developed the first time.

SPEED

For purification process development, we use a data-driven approach consisting of (a) systematic high throughput screening of resins under multiple loading and elution conditions using an automated liquid handler, (b) optional scouting chromatography runs to narrow down resin choices, (c) scale-down chromatography optimization, and (d) pilot-scale confirmation.

QUALITY

The use of periplasmic release procedures, some of which are patent-protected, provides a higher quality extract for subsequent chromatography steps.  Periplasmic extracts contain a significantly lower level of contaminants such as host cell proteins, DNA, and endotoxin, which minimizes downstream unit operations.  We have developed a toolbox of periplasmic release methods, which can be efficiently screened and optimized at small scale, followed by confirmation at pilot scale using scalable process equipment.

COST OF GOODS

High periplasmic expression of the target protein enables the use of an array of non-disruptive periplasmic release methods, which result in a higher purity extract leading to significant improvements in performance of downstream processing steps such as centrifugation, filtration and primary capture chromatography.  All developed periplasmic procedures are fully scalable to GMP facilities.