The development of a Microflow digital imaging (MDI) method to detect and monitor protein particulates in a high concentration IgG1 monoclonal antibody formulation is presented. The MDI assay was optimized and qualified as a characterization assay in terms of accuracy and precision of particle size
Characterization of site-specific glycation during process development of a human therapeutic monoclonal antibody
β Scribed by Amanda K. Miller; David M. Hambly; Bruce A. Kerwin; Michael J. Treuheit; Himanshu S. Gadgil
- Publisher
- John Wiley and Sons
- Year
- 2011
- Tongue
- English
- Weight
- 288 KB
- Volume
- 100
- Category
- Article
- ISSN
- 0022-3549
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