Solid Formulation Screening Workstation
The Solid Formulation Screening Workstation envisioned utilizes automation and robotics to help define the formulation and process for solid dosage forms such as tablets and capsules.
The need: current state of the art is mostly manual, predominantly empirical, and is both time and resource consuming. An opportunity exists to replace these existing workflows with efficient robotic systems.
This workstation is expected to:
• Be a critical and routine part of early development workflow for all small molecule compounds making a transition from drug discovery to development
• Replace existing business critical and routine workflows with lower full-time employee (FTE) burden, bench space, time, and material requirements
RFI ISSUED February 24, 2021
QUESTIONS on RFI DUE March 15, 2021
RFI RESPONSES DUE April 15, 2021
Q&A Received (Updated 3/26/2021)
Must the system be a benchtop system? Preferred (to minimize footprint) but not necessarily.
What would be the range in milligrams for dispensing of small quantities of different types of excipients and APIs? The range could be 10 mg to 2000 mg range, for example.
Does the "optionally apply pressure to compact the dry blend after mixing" mean to press tablets/pills? The idea is not to replicate a tablet press, but still to apply enough pressure to make a compact, so that one can study the effect of compaction. Lower pressures than tablet machine would be acceptable. Also, the idea is not to make tablets in any specific shape or size. The whole of the material can, for example, be compacted into one mass in the diametrical size of the mixing vessel.
The RFI states “reduced scale” and “uses low quantities of material.” Are there specific targets for the mg’s of API used per blend, and/or total mg’s of blended material for each blend? The team wants to use the lowest scale that continues to show relevance to the pilot scale of operation. The team realizes that the scale may not be reduced to extremely low mg quantities. Possibly, the scale that would be relevant here would be low gram scale (such as 2 g total powder in the vessel).
The RFI describes a phase for the project in which Beta instruments would be made available. Our organization believes its commercial capabilities align to most, if not all, of the requirements in this RFI. Therefore, is it acceptable to remove this Beta prototype phase to reduce overall commercialization timeline and cost? We should be Okay to remove the availability of beta version, or perhaps make it optional. The idea is to test out a prototype in one manner or another to see if it meets the requirements it was designed for. We are open to exploring different ideas/approaches on how this can be achieved.