Impact of extractables/leachables from filters on stability of protein formulations

Influence of particle shedding from silicone tubing on antibody stability

“…Given that also plastic leachables may impair protein stability, leachables were quantified in our study. This was performed in order to be able to delineate possible effects on protein stability from shed particles versus leachates.…”

Forced Degradation of Therapeutic Proteins

“…Adsorption of protein to the steel surface, as well as oxidizing effects of metals such as chromium oxide or leaching iron ions from steel, has been found to potentially trigger aggregation and particle formation 102,119,120. Moreover, extractables and leachables from filters have been found to destabilize IgG2 formulations during agitation and temperatures stress studies 121. For a detailed review on the influence of various surfaces and leachables on aggregation, the reader is referred to the review by Bee et al122…”

Stress Factors in mAb Drug Substance Production Processes: Critical Assessment of Impact on Product Quality and Control Strategy

“…However, leachables and extractables have been observed in various sterilizing-grade filters (such as polyvinylidene fluoride [PVDF], polyethersulfone [PES], and mixed cellulose ester [MCE]) that exhibited a complex pattern of destabilizing and stabilizing effect on physical/chemical stability of mAb including visible/subvisible particle formation. 160 The leachables and extractables presumably also displayed "surfactant activity." Leachables and extractables that have been characterized in these filters include organic carbon, metals, inorganic salts, and fibers.…”