Formulation development of antibodies using robotic system and high-throughput laboratory (HTL).
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.
Zhao
Hui
H
Novartis Pharma AG, Analytical Research and Development of the Process Science and Production Department, 4002 Basel, Switzerland.
Graf
Olivier
O
Milovic
Nebojsa
N
Luan
Xiaosong
X
Bluemel
Markus
M
Smolny
Markus
M
Forrer
Kurt
K
D000911:Antibodies, Monoclonal / Q000032:analysis*; D004339:Drug Compounding / Q000295:instrumentation / Q000379:methods*; D004355:Drug Stability; D057166:High-Throughput Screening Assays / Q000295:instrumentation / Q000379:methods*; D007753:Laboratories; D004364:Pharmaceutical Preparations / Q000032:analysis*; D055550:Protein Stability; D012371:Robotics
D000911:Antibodies, Monoclonal; D004364:Pharmaceutical Preparations