Problems and Solutions Critical Filtration of BioPharmaceuticals

摘要

Filtration of Biopharmaceutical solutions can cause a wide variety of tricky filtration problems caused by the variable and dynamic nature of the solution being filtered. These problems can cause serious issues for the filter user including loss of product, reprocessing, recall and federal regulation. Many of the problems encountered in the filtration of these solutions can be solved by choosing the appropriate filtration process steps and controlling the processing parameters.rnThis paper will highlight a number of these filtration related problems and the appropriate solutions to prevent and eliminate them. This will include problems associated with pyrogenicity, Mycoplasma contamination, sterility, filter life, long processing times, protein loss, and high operational costs. These problems and solutions are from actual situation encountered in Biopharmaceutical Processing.