As an industry, there is growing pressure to accelerate pharmaceutical development, in the face of increasingly complex modalities which actually require additional time if traditional approaches were utilized. Here we present a transformational paradigm on how we as an industry may develop formulations faster and with greater robustness, by leveraging advances in related fields and putting them together in a unique fashion. The synopsis of this approach is: 1) screen: Amgen has explored a unique approach to create formulations on a 96-well plate, up to 150-200 mg/ml depending on the molecule. This approach saves days to weeks as compared to traditional approaches, yet allows for a much larger exploration of the formulation design space; 2) stress: formulations in plates can be sealed and stressed to differentiate formulations, including thermal, transportation, oxidative and freeze/thaw, 3) analyze: several existing plate-based analytics have been utilized, but in addition there is new development data showing how critical quality attributes such as visible and subvisible particles can now be measured in a plate-based format, 4) verify: the lead candidates from this screening approach are set up on stability after subjecting it to representative processing conditions in Amgen’s new end-to-end drug product development facility. Real case studies, as well as documented time savings using these concepts will be presented. These studies pave the way for enabling modular and flexible studies in an expedient fashion that would enable robust pharmaceutical development for emerging therapeutics.

Accelerating pharmaceutical development: Case studies with automated approaches and formulation ‘miniaturization’

251st National Meeting (2016)

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