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.
Bio-pharmaceutical manufacturing is a complex, multistep process involving a very wide variety of process streams under different process conditions at different steps. These process streams include cell culture media, media additives, growth regulators in the upstream and post centrifuge cell harvest supernatants, post viral inactivation process intermediates, buffers, and high value product concentrates in the downstream. Filtration and purification of such a wide spectrum of process streams, to achieve different process objectives at each process step, is quite a challenge for the process owner. Also the increasingly competitive market conditions, due to the introduction of biosimilars, further escalates the demand for higher standards of filter performance, with respect to economy, safety, and impact on final product quality.