The use of in-line filters to remove fibrous material in the administration of intravenous fluids dates to the early 1830\'s. Following advancements in therapeutic interventions, high volume fluid support and parenterally administered drugs and biologic preparations, some observers are calling for a routine use of bedside filtration. Unfortunately, the assessment of filter components, their interaction and compatibility with the drug product, and the impact of use on clinical outcomes cannot be conducted by a single entity. Recommendations for use are often predicated upon fragmented and incomplete information. The current challenges in evaluating the benefit/risk profile for the use of in-line filters should not be ignored. While there are select instances showing well-defined therapeutic settings where in-line filtration of intravenous infusions would likely provide an additional safety margin and hence, net benefit, the majority of observational studies to date fail to provide sufficient scientific support for broad-based routine use. While infusion set filters are appropriate where expert opinion is well corroborated by scientific evidence, the general and routine use of filters used during parenteral administration cannot be supported by substantive studies and should not be routinely utilized. Ultimately, the determination falls to a healthcare provider with the information available at-hand.

Protein immunogenicity is intensively researched by academics, biopharmaceutical companies, and authorities as it can compromise the safety and efficacy of a biopharmaceutical drug. So far, the exact protein aggregate properties inducing immune responses are not known. Possible protein-related factors could be size, chemical modifications, or higher order structures. It is impossible to achieve an absolute absence of protein aggregates even for very stable formulations. The application of \"bedside filtration,\" meaning filtration during the preparation or administration of the drug product immediately before injection, has the potential to increase the safety of every drug container and could prevent the undesired injection of particulate matter into the patient. In this study, the high efficiency of filtration for reducing the amount of protein particles was demonstrated with more than 19 stressed and nonstressed biopharmaceutical products which covered a broad concentration and molecular weight range. Furthermore, critical aspects regarding the usage of filters such as particle shedding from filters, protein loss as a result of protein adsorption, or the hold-up volume of the filters were assessed. Although differences between the filters were observed, no negative impact by the investigated filters could be found. A broader application of bedside filtration is therefore proposed.