Product-Related Impurities: Tackling Aggregates
نویسندگان
چکیده
NOVEMBER 2005 Proteins can self-associate. For some proteins, self-association is natural and required for their function (e.g., tumor necrosis factor, TNF, is a homotrimer). However, proteins isolated from their native environment (such as in a vial or in an in-process fluid rather than in a cell or in plasma) can selfassociate into nonnative oligomers, both covalent and noncovalent. This has proven problematic for biopharmaceutical development because this may negatively affect process efficiency and/or subsequent clinical use.
منابع مشابه
Colloidal aggregation with mobile impurities.
The structure and aggregation kinetics of diffusion-limited cluster-cluster three-dimensional monomeric aggregates and gels is investigated as a function of the molar fraction of two types of impurities. In one case the impurities are allowed to aggregate among themselves whereas in the other the impurities are mobile monomers that remain as such during the whole aggregation process. Computer s...
متن کاملDevelopment of a novel and efficient cell culture flocculation process using a stimulus responsive polymer to streamline antibody purification processes
Recent advances in mammalian cell culture processes have significantly increased product titers, but have also resulted in substantial increases in cell density and cellular debris as well as process and product related impurities. As such, with improvements in titer, corresponding improvements in downstream processing are essential. In this study we have developed an alternative antibody harve...
متن کاملProduct-Related Impurities in Clinical-Grade Recombinant AAV Vectors: Characterization and Risk Assessment
Adeno-associated virus (AAV)-based vectors expressing therapeutic genes continue to demonstrate great promise for the treatment of a wide variety of diseases and together with other gene transfer vectors represent an emerging new therapeutic paradigm comparable in potential impact on human health to that achieved by recombinant proteins and vaccines. A challenge for the current pipeline of AAV-...
متن کاملImpact of residual impurities and contaminants on protein stability.
Production of recombinant proteins generates a variety of process-related impurities. The multistep manufacturing processes may introduce many potential contaminants into the final pharmaceutical products. These residual impurities and contaminants can potentially impact the protein stability significantly. In this short review, the authors intend to discuss major sources and types of residual ...
متن کاملDefining Your Product Profile and Maintaining Control Over It , Part 1 Session One of the WCBP CMC Strategy Forum , 19 – 20 July 2004
JUNE 2005 A well-characterized biopharmaceutical product is defined during its development by identification and quantification, when at all possible, of both process-related and product-related impurities. The expanding repertoire and sensitivity of the latest analytical methodologies enable detection and measurement of process impurities and product variants at increasingly lower levels and i...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
دوره شماره
صفحات -
تاریخ انتشار 2005