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Monomer purity is a critical parameter for monoclonal antibody therapeutic candidate in pre-clinical in vivo studies, because aggregate can affect antibody's bioactivity and immunogenicity as well as pharmacokinetics. Therefore, for in vivo studies, antibody's monomer purity typically needs to be controlled above 95%, and in some high-dose studies, one would need to increase the monomer purity to as high as 99%.
Monomer purity can be increased by removing antibody aggregates and fragments through polishing purification steps such as ion exchange chromatography, hydrophobic chromatography, and size exclusion chromatography. For some antibodies that are prone to forming new aggregates in certain types of buffer, polishing steps are not sufficient to increase monomer purity because new aggregates are formed in the polishing process. In such a case, one would need to optimize the formulation buffer that can prevent new aggregate formation.
Sino Biological has successfully produced several thousands of high monomer purity antibodies for customers worldwide. We are highly experienced in handling many challenging antibodies. Our expertise and experience in antibody purification can be of great value to our customers worldwide, especially for small biotech companies without a large in-house process development team.
How to Submit a Request for Antibody Purification Service?
If you are interested in using our antibody purification services to support your antibody discovery and development program, please contact us by leaving an on-line message or send us your detailed request to CROemail@example.com. Based on the quantity and quality requirement of your request, a formal quote will be send back to you for your review, comment, and/or acceptance.