AUTOMATION, ROBOTICS, AND AI-ENABLED HIGH THROUGHPUT SCREENING PLATFORM FOR WET GRANULATION
High shear wet granulation (HSWG) is an established pharmaceutical technology that is currently carried out in one batch at a time which creates several limitations:
(a) Very limited number of batches can be manufactured during product development because of containment requirements for relatively high powder loads and time required for processing. This leads to:
High API, development time, and FTE requirements, which are opposed to current industrial trends to try to minimize API and time consumption in early drug development.
Low resolution Design of Experiment (DoE) studies and inability to test process and formulation variables to identify the critical parameters/factors.
Statistical significance interpretation in the DoE studies is based on variability at one point of the DoE design – typically center point. The random variation is likely different at different points in the DoE space and an ability to run replicates at different points would provide greater scientific and statistical confidence in the DoE results.
(b) Difficulty in assessing the impact of bulk powder parameters to process scale-up in the context of process analytical technologies (PAT) that can be applied to larger scale manufacturing equipment. Miniaturized granulator might allow measurement of:
Torque using a calibrated shaft.
Powder wettability and flow parameters.
Rapid assessment of technology options for enabling new chemical entities and newer modalities of drugs through wet granulation routes in early stages of drug development.
A miniaturized, high throughput, multi-container granulator is proposed to address current limitations in the industrial practice of wet granulation (WG).
RFI ISSUED JANUARY 7, 2020
QUESTIONS DUE JANUARY 21, 2020
RESPONSES DUE FEBRUARY 18, 2020