FrieslandCampina Domo assures the consistent quality of our hydrolysates. This is done through a process-mapping (Quality-by-Design or QbD approach) strategy for our Biopharma hydrolysates. More information is available below (posters) and on request. Quality control assays have been developed in house for residual protease activity and endotoxin. R&D activities are continously ongoing to improve product consistency and performance.
Figure 1 depicts the effect of supplementation with 5 different batches of Proyield® Soy SE50MAF-UF on the growth curves CHO cell line CRL-11397. Figure 2 illustrates the increase in production of Immunoglobulin. To determine the growth enhancing effect 0.4% (W/V) hydrolysate solutions in a commercially available CD medium are tested using our validated growth assay. 25 ml of CHO (ATCC CRL-11397) cell suspensions are shaken on an orbital shaker (125 rpm) in 100 ml baffled flasks. Start concentration of CHO cells is 2*105 cells per ml. Cells are grown for 14 days (37°C/5%CO2). Growth is determined by measuring viable cell count using a cell analyzer, the Cedex HiRes. No feed is added during growth. Cell numbers are expressed in % with the maximum number of cells for non-supplemented CD medium (day 7) set at 100%.