In this work, we describe the application of two different high-throughput screening (HTS) techniques that can be used to determine protein stability during early formulation development. Differential scanning fluorescence (DSF) and differential static light scattering (DSLS) are used to determine t
Formulation development of antibodies using robotic system and high-throughput laboratory (HTL)
โ Scribed by Hui Zhao; Olivier Graf; Nebojsa Milovic; Xiaosong Luan; Markus Bluemel; Markus Smolny; Kurt Forrer
- Publisher
- John Wiley and Sons
- Year
- 2010
- Tongue
- English
- Weight
- 969 KB
- Volume
- 99
- Category
- Article
- ISSN
- 0022-3549
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โฆ Synopsis
Since each antibody has its unique physical chemical properties, optimal formulation for one antibody is likely not applicable for the others. To rapidly screen multiple antibody formulations, an automated system was constructed to perform sample preparation, testing, and data management. Using the automatic system, up to 500 liquid formulations can be prepared in deep well microplates and further distributed into standard microplates that can be stored under different stress conditions for degradation studies. In addition, the system can also be used to prepare samples in microplates for different analytical measurements such as UV spectroscopy, turbidity, dynamic light scattering (DLS), SEC-HPLC, RP-HPLC and CEX-HPLC, and automated lab-on-a-chip platform (ALP). The data generated using different techniques in the automatic system were comparable to those of the classical approaches.
๐ SIMILAR VOLUMES
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