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Technical Seminar Sponsored by SCIEX: Are Off-The-Shelf Formulation Buffers Suitable for Your Biotherapeutic Protein? The Effect of Buffer Formulations on Antibodies’ Proteoforms Relative Abundances

‐ Sep 15, 2020 8:35am

A number of buffers, approved by the FDA/EMA, are sold as being suitable for the formulation of antibody therapeutics. These buffers cover a wide range of substances, pH, salts, amino acids, sugars, and detergents.

Some of them have been optimized for certain antibodies in particular. Typically, pre-formulation of Abs starts at these sets of buffers, followed by further improving the conditions of a few selected buffers thereafter. However, to our knowledge, there is no study that has assessed the effect of these buffer formulations on the relative amounts of the antibody modifications (i.e., glycosylation, oxidation and others). Here we present a multiple attribute methodology (MAM) workflow on intact proteins upon reconstruction of data (intact MAM) using liquid chromatography coupled to high resolution mass spectrometry (LC-MS). For this study the effects of 96 commercially available buffer formulations were assessed focusing on the relative abundances of endogenous modifications of the Trastuzumab and our inhouse antibody 17b. For the evaluation, an LC-MS method and data processing workflow for intact MAM were established. Results are presented for a time course study of 7 days of storage at multiple temperatures determining the effect of the different formulations with the optimized method enabling the throughput needed.