As pipelines in the biotech industry become more diverse, the IP landscape progressively more competitive and speed evermore critical, it has become increasingly important to develop the means to rapidly and efficiently perform Drug Product development. Formulation development, one of the key aspects of Drug Product, has traditionally been a labor-intensive, multi-year process. Conventional bench-scale (~100 mL) formulation development faces key challenges, including extensive material and analyst time, both of which result in significant timeline requirements and limit the composition space that can practically be evaluated. Wellplate-based screening, on the other hand, which has relied on liquid handler-spiked formulations, has been limited by carryover and low protein concentrations that are often an order of magnitude below the final target. Amgen has developed and implemented several innovative automated capabilities, e.g. plate-based buffer exchange, to overcome these limitations and to establish a new high throughput formulation screening approach. Case studies will be presented demonstrating application of these technologies to tackle various Drug Product challenges, such as minimizing the viscosity of high concentration molecules and exploring large design spaces for novel modalities. New approaches to multivariate study design, automated analytical testing, data analysis and decision-making will be described. At the same time, the hurdles and system limitations that have been identified as well as future directions will be discussed.

Innovations in high throughput formulation screening: Promise and reality

255th National Meeting (2018)

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