August 26, 2022

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The ETC is seeking companies interested in developing a robust, automated, user-friendly high throughput platform that can execute reliable solubility measurement.  Proposals/responses describing the development and application of creative and innovative solutions to address current challenges is encouraged, including with potential integration to combine different existing technologies.

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Current high throughput platforms for solubility workflows present challenges for the measurement of accurate, reliable, and reproducible solubility data across a range of experimental conditions and solvent types. The ETC aims to identify new, unique, and integrated solutions to address these challenges and to partner with vendor(s) to evaluate development of a platform that is robust, automated, high-throughput and enables customization of workflows/recipes by expert users but also accommodates routine workflow execution by general users. The workflow may include hardware and software components for necessary unit operations, for example, solid dispensing, liquid dispensing, equilibration and mixing, solid-liquid separation to sample a solution aliquot, sample preparation for analyses, and analyses of the residual solids. 

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Download the Request for Information and submit your response.

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RFI ISSUED:  August 26, 2022

QUESTIONS on RFI DUE to ETC:  September 16, 2022

RFI RESPONSES DUE to ETC:  October 21, 2022

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Q&A (Updated September 28, 2022) - Note see FAQ document for answers to common questions

1. We observed that this file was called “Phase 2” and that the ETC website lists a previously-completed project called “Automated Solubility Platform.” Is there any relevant background information from that project that can be shared?  For example, are there compatibility expectations for the current RFI?  The RFI you refer to was originally intended to deliver solubility filter consumables and an automated platform for conducting the experiments.  The team at the time decided to decouple these two projects and first focus on the solubility filter consumables.  This new RFI is an update to the original proposal with updated specifications to assess new and innovative solutions and focused on the high-throughput automated hardware and accompanying software.  There are no compatibility expectations beyond anything provided in the specifications.

2. Is there an expectation or requirement for the individual sample volume or the number of parallel experiments?  Concentration ranges are mentioned, but we did not see a range for the experiment scale or system capacity. Individual sample volumes can be provided in the proposal response and (1) should be sufficient to ensure representative measurement of solubility, (2) enable downstream analytical testing included in your proposed platform (e.g., HPLC, XRPD, FTIR, pH, etc.), and (3) desirable to minimize solute requirement per individual sample and waste generation, to enable solubility measurements in early stages of development. The solubility platform is intended to be enable a high-throughput automated workflow, which is typically considered to include at least 24 experiments in each run. We acknowledge that this may change depending on the extent of automation, types of unit operations that are automated, and degree to which different unit operations may be executed in parallel in your proposed workflow. 

3. In section 2.3.1 “Analytical measurement requirements,” please confirm if the proposed solution should focus on analytical sample preparation to facilitate offline analysis (for HPLC, XRPD, FTIR, Raman), as opposed to performing all types of analysis in a physically-integrated system.  End to end automated setup is ideally desirable that can enable automated sample preparation and testing into a single system. Nevertheless, a combined approach can also be considered where a component/type of the testing analyses is integrated into a single system and other a component/type of the testing analyses are offline. 

4. In section 5.4 “Estimated Project Cost,” can ETC share the expected level of funding available for this project? Unless specified in an RFI/RFP, the funding available for projects is not determined up front. Project budgets are dependent on the project proposals received along with interest from ETC members in pursuing a particular project. Respondents should estimate the cost of the project and the total funding sought from ETC. Historically ETC funding has been in the $0 - $400,000 range spread over 1-3 yrs. but there is no hard limit on the amount of funding. Once a project is scoped out and a Statement of Work available, the ETC members will determine if there is sufficient interest to fund a particular project and meet the requested funding amount. The funding provided by ETC to a commercial vendor should be considered seed funding to supplement the total development costs, with the collaboration investing as well since with most projects, all commercialization rights will reside with the collaborator and ETC will not assume ownership of any intellectual property (IP) developed by the collaborator or expect royalties from future commercial sales.  Please refer to our FAQ document on our website for answers this and related questions.  

5. Over the years we have found several means of automating filtration, including but not limited to filter paper, filter plates, disc membrane filters and vial filters. Does the consortium suggest any preference for the type of filtration method that should be utilized by preference?  The ETC is interested in understanding and exploring innovative approaches to design a high-throughput automated platform for measurement of solubility. If a solid-liquid separation operation is required in your proposed platform/workflow, the ETC expects that it (a) can enable reproducible and consistent separation of solids and liquids under equilibration temperature conditions, (b) exhibits universal compatibility with organic and aqueous media, (c) allows retention of solid residue post-equilibration for solid-polymorph analyses and (d) achieves desired separation outcomes in maximally automated workflows.

6. ETC has the right to modify or cancel the RFI at any time. How about the actual project? How are costs handled in case of termination of an approved ongoing project?  It varies but for most ETC projects greater than 12 months, there is typically a go/no-go point in the project timeline where ETC evaluates the progress made to date and decides if the they wish to continue the project. The contract between ETC and the 3rd party would specify any early termination costs for projects that don't continue.  Also generally payments to the 3rd party collaborator are based upon achieving milestones set forth in the project Statement of Work developed by the 3rd party and approved by ETC.  The actually project specific termination information will be agreed upon by ETC and the 3rd Party collaborator.

7. Are the requirements of sections 2.3 and 5.2 for the current state or for the final deliverable?  Preferably the final deliverable.  ETC is seeking to partner with a 3rd party that will eventually deliver a commercially available and supported solution.

8. Can software be provided as a cloud-based service? Yes, cloud-based service may be provided. If there is a software component to your proposal, the ETC recommends that you include in your proposal response the capabilities of the cloud-based service, user access, potential licensing and accompanying software requirements requested in the RFI. 

9. Do software source codes remain property of the collaborator also in cases of self-hosting? Yes, the collaborating 3rd party usually retains ownership of all IP developed related to the project however any data generated by ETC members in testing the hardware or software are owned by that ETC member.

10. Commercial availability and support globally could become an issue (sanctions etc.), is there a minimum criterion for geographies?  ETC members are global companies so they would expect to be able to purchase equipment to support their operations world-wide.  At a minimum, North America, Europe, and Asia

11. What are the allowed changes/leeway in terms of timelines, milestones and budget after approval? Can additional milestones/deliverables be added after approval.  The budget for any given SOW needs to be a fixed price (or not to exceed price) since ETC members participating on the project need to have budget certainty when committing to a project. Changes to an SOW after execution can be accomplished through the agreed upon change order process.

12. Are there any requirements for allocation of the project budget (geography, personnel, outsourced services etc.) or is this up to the collaborator?  This is up to the third party collaborator.  However, ETC will review this information and consider it before engaging in a project.

13. Can the hardware be commercially provided on a license basis?  You can make your hardware available to your customers any way you wish.  This is a business decision for your company.

14. Does the agreement include clauses preventing reverse-engineering?  Yes, in the Non-Disclosure Agreement states that the party receiving confidential information shall not disassemble or reverse engineer any of the confidential information.

15. What is the expected timeline for the approval process? When is the project estimated to begin? Unknown at this time as the process depends on many factors but it could potentially start in Q1 / Q2 2023. The team will review the proposals received starting the end of October and schedule interviews with those respondents who rank high against our scoring matrix. The interviews will likely take place in November/December timeframe with the goal to select one respondent to work with in order to define a project scope and draft an SOW outlining milestones, deliverables, timeline, and cost to ETC.  Once a final SOW is available, the ETC members will be polled to see if they wish to support the project and if enough support is reached, the project will be Chartered and ultimately executed. 

16. What is the minimum sample throughput requirement? (e.g., 50 samples per day)   The solubility platform is intended to be enable a high-throughput automated workflow, which is typically considered to include at least 24 experiments in each run. We acknowledge that this may change depending on the extent of automation, types of unit operations that are automated, and degree to which different unit operations may be executed in parallel in your proposed workflow. Higher experimental throughput is desirable provided the experimentally measured solubility results are representative, accurate and precise. 

17. Is there a preferred consumable type that is used in the current process?    Current workflows for solubility measurement vary across the participating ETC members, but rely on well-plate and/or vial configurations. We are willing to understand new, alternative capabilities and options that you may recommend in your proposal response. We expect that your recommended type of consumable will be compatible for use with process-relevant, bio-relevant media and organic solutes, including at elevated temperature conditions for measurement of solubility.

18. What are the typical powder and liquid materials used in your solubility measurement process?  Powders are organic solutes and/or salts of relevance to pharmaceutical process development with varying physicochemical properties, including particle size, flowability, caking, etc. Liquids are organic and/or aqueous neat solvents and/or mixtures that are process-relevant (e.g., crystallization design) or bio-relevant. 

19. Are there any particularly hazardous materials involved in the solubility measurement process?  Organic solvents used for process-relevant media are expected to need considerations for the contained management of their flammability, volatility, etc. Solid powders are organic solutes and/or salts that are expected to need considerations for contained management as a result of their potential combustibility, pharmacology, etc.

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