High-throughput viscosity measurement using capillary electrophoresis instrumentation and its application to protein formulation

2014 ◽  
Vol 99 ◽  
pp. 51-58 ◽  
Author(s):  
Andrea Allmendinger ◽  
Le-Ha Dieu ◽  
Stefan Fischer ◽  
Robert Mueller ◽  
Hanns-Christian Mahler ◽  
...  
Keyword(s):  
Capillary Electrophoresis ◽  
High Throughput ◽  
Viscosity Measurement ◽  
Protein Formulation

scholarly journals Improved Fluorescence Methods for High-Throughput Protein Formulation Screening

2018 ◽  
Vol 23 (6) ◽  
pp. 516-528 ◽  
Author(s):  
Yangjie Wei ◽  
Nicholas R. Larson ◽  
Siva K. Angalakurthi ◽  
C. Russell Middaugh
Keyword(s):  
Steady State ◽  
High Throughput ◽  
Protein Formulation ◽  
Formulation Development ◽  
High Concentration ◽  
Direct Optimization ◽  
Biophysical Characterization ◽  
Formulation Optimization ◽  
Long Term Storage ◽  
High Protein Concentration

The goal of protein formulation development is to identify optimal conditions for long-term storage. Certain commercial conditions (e.g., high protein concentration or turbid adjuvanted samples) impart additional challenges to biophysical characterization. Formulation screening studies for such conditions are usually performed using a simplified format in which the target protein is studied at a low concentration in a clear solution. The failure of study conditions to model the actual formulation environment may cause a loss of ability to identify the optimal condition for target proteins in their final commercial formulations. In this study, we utilized a steady-state/lifetime fluorescence-based, high-throughput platform to develop a general workflow for direct formulation optimization under analytically challenging but commercially relevant conditions. A high-concentration monoclonal antibody (mAb) and an Alhydrogel-adjuvanted antigen were investigated. A large discrepancy in screening results was observed for both proteins under these two different conditions (simplified and commercially relevant). This study demonstrates the feasibility of using a steady-state/lifetime fluorescence plate reader for direct optimization of challenging formulation conditions and highlights the importance of performing formulation optimization under commercially relevant conditions.

High resolution and high throughput analytical methods for d-tagatose and process related impurities using capillary electrophoresis

2020 ◽  
Vol 609 ◽  
pp. 113981
Author(s):  
Sri Rama Krishna Surapureddi ◽  
Kunta Ravindhranath ◽  
Ghantasala S. Sameer Kumar ◽  
Prashanth Chiliveri ◽  
Sreedhar Reddy Sappidi
Keyword(s):  
Capillary Electrophoresis ◽  
High Resolution ◽  
High Throughput ◽  
Analytical Methods ◽  
Related Impurities
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