A Critical Evaluation ofTm(FTIR)Measurements of High-Concentration IgG1Antibody Formulations as a Formulation Development Tool
β Scribed by Susanne Matheus; Hanns-Christian Mahler; Wolfgang Friess
- Book ID
- 106492807
- Publisher
- Springer US
- Year
- 2006
- Tongue
- English
- Weight
- 331 KB
- Volume
- 23
- Category
- Article
- ISSN
- 0724-8741
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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
Protein solubility is a critical attribute in monoclonal antibody (mAb) formulation development as insolubility issues can negatively impact drug stability, activity, bioavailability, and immunogenicity. A high-throughput adaptation of an experimental method previously established in the literature