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Werner, Benjamin Patrick; Winter, Gerhard (2018): Expanding Bedside Filtration-A Powerful Tool to Protect Patients From Protein Aggregates. In: Journal of Pharmaceutical Sciences, Vol. 107, No. 11: pp. 2775-2788
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Abstract

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.