Biopharmaceutical manufacturing processes involve multiple process steps with a wide variety of process streams, including some with the most challenging contamination profiles. These contaminants range from cell fragments, cell organelles, colloids and lipids to very fine protein precipitates. Some of these process steps use filter aids which although aid in retention of some of these contaminants, contribute their own fines into the downstream. As expensive and sophisticated equipment and consumables are used for downstream purification, such high contamination profile process streams tend to rapidly clog the 0.2µm filters, normally used to protect these.
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