July 19, 2021

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The ETC is seeking information from companies interested in supplying a commercially viable, automated instrument for the analysis of “visible particles” that are 30 µm and above in size. This instrument must allow non-invasive, non-destructive (no impact on the sample quality and property) measurement of particles and robust data analysis of particle shape, number, and size.

 

Download the Request for Information and submit your response.

 

RFI ISSUED July 19, 2021

QUESTIONS on RFI DUE August 2, 2021

RFI RESPONSES DUE August 20, 2021

Q&A Received (updated 8/25/2021)

1. Can you give a range in which this shall take place. Are we talking about tens, hundreds or hundreds of thousands? There is no specified range. However, an instrument that is flexible enough to cover a wide range of samples sizes is preferred. Focus is on laboratory sample sizes, typically n=20 up to 500 per day, scalability is an important aspect.

2. Is there are range of an estimated throughput? We currently do not have an expected throughput/time per sample, but throughput is considered an important component of the system that should be taken into account, in addition to data quality, etc.

3. Which type of automation is desired?  The preference is for analyzing single units (in line with PDA and USP discussions). Samples should be handled automatically for “inspection purposes” from e.g., trays and sorted in accept / reject bins, samples can be put manually into those storage trays/bins (manual loading).

4. Is there any requirement regarding the sample inlet, buffering, etc? How will samples be presented to the instrument? Nested, in trays, …? As stated above, the preference is for analyzing single units (in line with PDA and USP discussions). See above

5. We understand that the main target of development work is around the methodology and test setup itself in the first place and automation etc. as a second step, is that correct? The focus is to have an instrument capable of collecting high quality data with very low false positives/false negatives. However, as indicated in the RFI, the goal is to develop a commercially viable, automated instrument for visible particle analysis. Therefore, scalability is an important aspect of the instrument that should be taken into account. 

6. Please confirm typical/desired device properties:
   •    Diameter
   •    Length
   •    Fill volume range
   •    Special factors geometries (e.g. for PFS or cartridges)
   •    Would samples be labeled (size and placement)?
   As stated in the RFI, the instrument and accessories should be capable of handling various type of containers, including but not limited to pre-filled syringes (PFS), vials, cartridges, rigid glass, and transparent plastic containers with volumes up to 50 mL. Visual inspection would occur on nude (i.e., unlabeled) samples.

7. For opalescent samples (~30 NTU), are all other requirements unchanged? Yes

8. For high viscosity samples (50 cP), are all other requirements unchanged? Yes

9. The RFI states “The instrument should be usable in a typical laboratory environment.”  
   •    Is the desired system a stand-alone instrument?
   •    Is there an expectation that samples would be manually loaded by the user?
   •    If automated sample loading is required/preferred, please clarify the target throughput and sample capacity.
   The focus is to have an instrument capable of collecting high quality data with very low false positives/false negatives. However, as indicated in the RFI, the goal is to develop a commercially viable, automated instrument for visible particle analysis. Therefore, scalability is an important aspect of the instrument that should be taken into account. 
   
   The preference is for analyzing single units (in line with PDA and USP discussions). Samples should be handled automatically for “inspection purposes” from e.g., trays and sorted in accept / reject bins, samples can be put manually into those storage trays/bins (manual loading).
   
   We currently do not have an expected throughput/time per sample, but throughput is considered an important component of the system that should be taken into account, in addition to data quality, etc.

10. What is the estimated financial contribution from ETC?  Unknown at this time.  Project budgets are dependent on the project proposals received along with interest from ETC members in pursuing a particular project.  Historically ETC projects have ranged from $0 - $500K total spread over 1-3 yrs.   Also, please keep in mind when ETC partners with a commercial vendor, any monetary resources provided by ETC should be viewed as seed funding to supplement the total development costs with the collaborator 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.

11. Will the instrument be required to take measurements non-invasively or can a sample be extracted from the various containers for analysis? The instrument is required to be non-invasive and non-destructive (no impact on the sample quality and property).

12. If the measurements must be conducted non-invasively, will the instrument need to be designed to handle different containers, or can each instrument be manufactured to a specific container type?  The instrument and accessories should be capable of handling various types of containers, including but not limited to pre-filled syringes (PFS), vials, cartridges, rigid glass, and transparent plastic containers with volumes up to 50 mL. In addition, the instrument should be scalable to adapt to different sample sizes; the more flexible, the better. Having different accessories that are easily exchanged on the same instrument to accommodate different containers could be an option.

13. Will the instrument be expected to analyze the entire fluid content of each container? If not, what is the acceptable minimum sample volume?    Yes, the instrument should be able to analyze the entire fluid content of each container.
    The RFI mentions particle size range of >= 30 um. Is there an expected maximum particle size range?    There is no maximum particle size range defined.  The instrument should be able to detect all “visible particles” present in the container.

14. Are there any expectations on when this project should be completed? What is the expected timeline for delivery of such an instrument?     The current expectation is to have the project be completed within 2-3 years. But defining this could be part of your proposal and subsequent discussions with the team.

15. For such an instrument contemplated by the RFI, what is the expected range of acceptable price points?  ETC has no expectations on the price range of commercial products or services developed in collaboration with ETC.  It is recommended that the vendor conduct their own market analysis to gather these types of information from their current and potential customers in order to set a price point aligned with market expectations.  Please note that ETC as an organization will not and cannot participate in such analysis.

16. Section 2.2 discusses the use and challenges of semi-automated and automated systems in general terms. Yet, Amgen recently published that they had validated an automated system at their plant in PR. Recognizing, of course, that the RFI is for a laboratory system and the PR system was for production, do the same issues exist on this newly validated system? (E.g. lack of morphological and size data, high rate of falsely rejected units, etc.). The newly validated system addresses very specific questions that are only a subset of the features what we are requesting, and so the difficulties we outlined are not necessarily applicable to that instrument.

17. Is this system only for particle defects, or are cosmetic defects in the container also part of the scope? Cosmetic defects are outside the scope of this project.

18. Your hardware requirements indicate that you want a “flexible sample size”. For example, do you mean you want the system to inspect more than 1 unit at a time or that you wish to automate feeding single-unit inspection across varying sample/lot sizes? The preference is for analyzing single units (in line with PDA and USP discussions), with varying sample lots/sizes/containers. 

19. What is the expectation of throughput/time per sample? We currently do not have an expected throughput/time per sample, but throughput is considered an important component of the system that should be taken into account, in addition to data quality, etc.

20. Please provide examples of desired output for “solution behavior, optical properties”. These behaviors can often help differentiate between sample types, the details would be up to the instrument manufacturer, but could include things like translucency of particles, sinking to the bottom during rotation, floating to the top, or staying suspended, etc.

21. In 1.3. it is mentioned that responses submitted in response to the RFI become property of ETC. We do want to give you the best possible answers and ideas from our side that might include confidential information. Therefore we suggest to sign a 2 sided NDA. Is that acceptable for you? How would confidentiality be granted between ETC and the partners?  ETC requests that you do not provide confidential information in your response (Please see section 1.3 Disclaimer in the RFI).  Once we get to project scoping or project execution stage an NDA can be executed at that time, if required.

22. After the collaborator has been selected, what shall the timeline for the development look like?  In general from the time the RFI is released until project start is approximately 6-12 months but that can be faster or slower depending on the project.  The timeline depends on a lot of factors but primarily driven on how quickly a Statement of Work (SOW) can be created and agreed upon by both parties.  Once that process has made enough progress the ETC Secretariat will work with the collaborator on the Development Agreement, leveraging the ETC template language which has been approved by all our members.  After that is completed and SOW finalized, ETC drafts their internal project Charter which describes the deliverables, costs, timeline, licensing, benefits, etc. derived from the Development Agreement and SOW and sends for internal company review and signature - this is also a templated document to speed up review.  The Charter process is fixed at 6 weeks if there are no items to work out from the review.  Once the Charter is executed by all participating member companies, ETC will execute the Development Agreement and NDA with the collaborator which should be quick since this has already been negotiated (1-2 days).  

23. We as an engineering company are also partnering with universities for joint developments. Can we include them in our proposal or do we need to apply as a single organization?  Yes, you can include them in your proposal.  ETC recommends/prefers that the collaborator treat their partner(s) as subcontractors/service providers so that the agreements and negotiations are only between ETC and the collaborator, with the collaborator responsible for ensuring that their partner(s) adhere to the terms set forth in the agreement.  However if this isn’t possible, we can contract with multiple parties.  

24. Which role will the ETC have during the development project?  Depends on the project but typically the ETC members participating on the project will provide subject matter experts and/or scientists to serve as a resource to the collaborator, providing support, data, samples, insights, testing and evaluation of deliverables,  provide feedback, etc. 

25. It is mentioned “possible” partners in point 2.1: when will be decided which partners will be part of the project? How many partners are usually taking part?  The final number will be determined when the project Charter is drafted.  Each of the partners will indicate their willingness to participate in the project based upon the SOW and recommendations from their representatives on the project team.  Historically we have had projects with 4-10 companies participating.

26. In point 2.3.4. it is mentioned that “Software will be licensed to ETC participants at no cost during (i) development and (ii) a mutually agreed beta testing period.” Which software is mentioned by that? We understand the instruments consists of both soft- and hardware.  This is a general statement referring to any software developed as part of the project or required to participate in the project (e.g., data capture or instrument control software) to evaluate beta/prototype units.  It does not include downstream or upstream software that isn’t directly related to the project.  For this project, we would suspect there would be a need to have software related to the visible particle analytical instrument provided to ETC so the team can evaluate the hardware.

27. In point 4.8. it is asked to reply to each requirements – Does this refer to the ones in chapter 2.3. only or are there any additional requirements in separate documents?  Yes, this only refers to the ones in 2.3.  There are currently no other specification requirements. 

28. What is the expectation in 5.1. ? What shall be part of the proposal?  This is where you would enter your proposal information.  It is free form to allow you to enter what information you deem relevant to your proposal. 
    Which Functional Requirements and Specifications checklist are meant here? The table seems to be empty.  The intent is that the requirements from section 2.3 would be transposed here so you can refer to each of them one by one (this is the table mentioned in 4.8)

29. 5.3. – Are you referring to the timeline until a fully developed and commercial product?  No, this is timeline for the project and when specific milestones/deliverables would be met.  Any predictions or thoughts on a commercialization timeline would be provided in 5.5.

30. There are various Ips mentioned from AMGEN in the proposal. Are there any other IP from other potential partners that may be mentioned already?  This is the only IP that we are aware of.  As stated in the appendix,  there may be other IP beyond what is already provided.

31. Is there the possibility of our company to become part of ET?  Unfortunately no, ETC membership is limited to companies engaged in the development of new chemical or molecular entities for the prevention, diagnosis, or treatment of disease with at least one active Clinical Trial Application.