Development of a spatially resolved spectroscopy probe for application in pharmaceutical drying processes (Drying PAT)
To understand the drying unit operation in the pharmaceutical industry, it is desired to collect real-time data over the course of the drying process. The current state of real time data collection suffers from limitations of existing Process Analytical Technology (PAT) tools, process measurements, and/or material sampling technologies.
We are seeking a project to develop PAT to monitor the drying of pharmaceutical compounds in agitated contact dryers. The project would include:
- Design and development of a probe or probe-like instrument with integrated optics for the application of spatially resolved spectroscopy (e.g. IR and/or Raman) in agitated vacuum contact dryers to profile the drying process throughout the vessel.
- Development of spectral analysis methods, models, and calibrations to determine solvent content, physical form, and particle size distribution across a range of conditions.
The project proposal should be broken into phases including:
- Design of probe(s) with feedback and revisions from participating members
- Outreach and collaboration with dryer manufacturers to integrate probe with drying vessels
- Evaluation of performance across a range of materials and conditions
- Development, calibration, and validation of data processing methods
RFP issued October 23, 2017
Responses due December 4, 2017
Questions Received (Updated November 10, 2017)
- Does ETC expect a company to lead the proposal or it is okay for an University-based team to lead? ETC welcomes responses from any interested parties, including a University-based team. The ETC is open to either University or company led teams, and it is not an expectation that this project would be led by a company based team.
- Does the team need to include a dryer manufacturer and/or pharmaceutical company? The RFP mentions outreach and collaboration with dryer manufacturers and taking feedback and revision from participating members, but would they need to be identified and join the team now? Could ETC also provide information for connection (if successful in RFP)? The RFP should outline the project plan in the proposal, including what subject matter expertise is required to execute the plan. The ETC team will provide subject matter expertise from the Pharma company perspective as part of this project and would be available to serve in roles such as feedback and testing of prototypes.
- We anticipate the project will generate new IP, and would like to know who will/could own the IP. How would it work with ETC, all companies in the consortium, and manufacturer/members collaborating or providing feedback during the project? In general, ETC does not intend to retain IP from collaborations with third parties unless any ETC member company IP was included in the project. All other details relating to IP will be addressed in the contract for the project.
- If new IP is generated, could we ask funding from ETC/participant companies to secure and/or access the IP? Any funding requests should be included in the proposed budget. Since ETC will not retain any new IP generated in this project (unless any ETC member company IP was included in the project) we anticipate that the collaborator would fully fund any costs to secure the IP themselves. Regarding access to the IP, for any prototypes delivered to ETC as part of this project, we expect that a license is granted for use of that prototype; for any commercial products purchased by ETC members participating in this project we expect there will be license fees associated with any purchases and hope that discounts or credits towards those purchases would be made available to those ETC companies who helped fund development. This information should be included in the proposal.
- Should the developed system get commercialized, will there be any preference given to industrial partners involved during the development and prototyping stage to produce the final product? Would this change depending on the partners' involvement, i.e., if they contribute in-kind or financially? The IP and know-how raised during the project could be critical for successfully commercializing the system to make it available to ETC member companies. ETC has no preference on industrial partners involved during the development and prototyping stage to produce the final product regardless of ETC’s contribution. It will be up to the collaborator to decide how the final product will be produced. As stated above, the IP would reside with the collaborator unless any ETC member company IP was included in the project.
- What is the expected delivery timeline and what is the expected duration of the project? The delivery timeline will be discussed in detail after a collaborator has been selected, but please include a proposed timeline in your response.
- Could you advise the process and timeline following the submission of RFP? Following submission of RFP responses, the team will evaluate proposals and send further questions for clarification as needed before selecting a collaborator. An in-person scoping workshop may also be scheduled with the selected vendor to further refine the proposal and project. Pending further discussion in the ETC roadmap, the project is expected to begin in 2018.