Inactive

SUMMARY: This is a Sources Sought notice and not a request for quotes. This request is solely for the purpose of conducting market research to enhance VHA s understanding of the market s offered produ... SUMMARY: This is a Sources Sought notice and not a request for quotes. This request is solely for the purpose of conducting market research to enhance VHA s understanding of the market s offered products, services and capabilities. The Government will not pay any costs for responses submitted in response to this Sources Sought. This Sources Sought notice provides an opportunity for respondents to submit their notice of ability, and their available products and services in response to the requirement described below. Vendors are being invited to submit information relative to their potential of fulfilling the requirement below, in the form of a capability response that addresses the specific requirement identified in this Sources Sought. The Veterans Health Administration (VHA) is seeking a vendor to provide the following products and/or services below. Please see the General Requirements section below for the requested products/services and descriptions. This Sources Sought is to facilitate the Contracting Officer s review of the market base, for acquisition planning, size determination, and procurement strategy. A. GENERAL REQUIREMENTS Cytokine Release Assay Scope of Work: This study is necessary to predict the severity of potential cytokine storm reactions that may occur upon injection of proteins into first-in-human clinical trial recipients. The Contractor will use cohorts of 20 healthy volunteers and the assay can be completed in 4-6 weeks. Using healthy volunteers is ideal, for safety and tolerability in healthy individuals before moving to separate Phase 2 trials in individuals with MS, Stroke, Methamphetamine Abuse and TBI. 2. Specific Tasks. The following tasks are to be performed by the Contractor: Cytokine Release Assay Donors: 20 Number of client test conditions for analysis: 18 Provision of alemtuzumab (Campath) for us as a high response comparator Provision of cetuximab (Erbitux) for us as a high response comparator Breakdown of TOTAL above by Deliverable Compensation for Deliverable 1 (allocation of laboratory time) 40% Compensation for Deliverable 2 (delivery of Reports) 60% Approximate Delivery Time: 8 weeks Task 1: Cytokine Release Assay a. Cytokine Release Assay is an in vitro cytokine release assay carried out on fresh human blood samples designed to aid in the prediction of first infusion-related reactions. It will be performed as described below analyzing the number of test articles provided by Client as set out in Table 1. b. Contractor will identify a panel of healthy donors and draw a suitable volume of blood into heparin Vacutainers (see Table 1 for number of donors). Heparinised blood samples will be used fresh (<3 hours post draw). Healthy donors included in the assay are self-certified as: 1. Being free from symptomatic viral and bacterial infections. 2. Having not received steroidal anti-inflammatory medication for 7 days prior to blood draw. 3. Having not received non-steroidal anti-inflammatory medications for 3 days prior to blood draw. 4. Not currently receiving blood-thinning medication. c. Each test article will be analyzed at 4 concentrations indicated in Appendix 1 in undiluted whole blood with positive and negative control conditions. After incubation, plasma will be isolated and measurement of the following cytokines will be made in replicates in pg/mL: IFN , TNF , IL-2, IL-4, IL-6, IL-8 and IL-10 using an immunoassay. Task 2: Deliverables a. Deliverable 1: Upon order receipt Contractor will allocate laboratory time within its workflow to carry out the service and acknowledge the order. b. Deliverable 2: PDF summary report in the format and with the detail shown in reporting template for the assay of Section 1. Task 3: Consideration and Payment Schedule a. The consideration of Deliverable 1 shall be 40% of the total project cost as set out in Table 1, to be invoiced on completion of the Deliverable 1 (i.e. at the time of order acknowledgement). b. The consideration of Deliverable 2 shall be 60% of the total project cost Table 1, to be invoiced on completion of the Deliverable 2 (upload of reports to the Contractors secure webserver with notification to client). Task 4: Details relating to the provision of test articles by Client a. Test Article quantity / concentration: The concentration of the test article must be no less than 50 times the final upper test article concentration. Where that final upper test concentration is 100 g/mL, this is 5mg/mL. Based on a final upper test concentration of 100 g/mL, for each donor blood sample in the assay a minimum of 0.5 milligrams of each test article is required. For example for a 20 donor project, a minimum of 10 milligrams of each test article is needed. b. Sample purity and the methods used to assess this purity The nature of the assay is such that common contaminants and carry-over products from bench-scale purification may evoke a false positive response and/or enhance the background. For example protein A, LPS, endotoxin and bovine albumin need to be eliminated from the test article samples. For antibody preparations, we recommend the antibody is produced from cells that have been cultured using serum-free conditions and that a minimum of two chromatography steps is performed e.g. Protein A (or equivalent) followed by ion exchange in sterile, LPS and endotoxin-free solutions and equipment. As general guidance, near clinical grade purification should be applied for test articles destined for these assays. Aggregation status, deamidation status and also the glycosylation profile of molecules are known to influence the propensity of proteins to evoke assay responses. The storage buffer formulation should be designed to minimize aggregation and deamidation, oxidation etc. We will store test articles according to guidance provided by the Client in the buffer supplied. Working solution of the test articles will only be generated at point of use in the assay. Aside from visual inspection, we will make no quality assessment of the test articles we receive. Furthermore, it may be appropriate to supply a sample of the storage buffer to use as a null control treatment. This control will be considered as an extra test article for analysis. c. Sample formulation The contractor can work with most buffer formulations; Phosphate-buffered saline (PBS) is preferred. The cells will be affected by acid or strong basic pH so it is requested that the buffer formulation be approximately neutral (pH7). Clients are reminded that the formulation should not contain azide or other preservatives toxic to viable cells. d. MSDS To satisfy local safety regulations, we will also require MSDS for all samples. e. Labelling Please ensure that all formulation vials have a unique identifier label. Test articles should not be labeled Formulation 1, Formulation 2 etc to avoid confusion with other orders. APPENDIX 1: Test Article Details Protein Sample Details ID Quantity (mg) Sample format Concentration (mg/mL) # Vials Comments Assay Test Concentrations Monomer in Excipient 1 To be confirmed Solution or Lyophilised XX mg/ml To be confirmed 4 concentrations TBD Excipient 1 Alone To be confirmed Solution or Lyophilised XX mg/ml To be confirmed To be used at equivalent volume Monomer in Excipient 2 To be confirmed Solution or Lyophilised XX mg/ml To be confirmed 4 concentrations TBD Excipient 2 Alone To be confirmed Solution or Lyophilised XX mg/ml To be confirmed To be used at equivalent volume Campath® Provided by Contractor 0.1, 1, 10, 100 g/mL Erbitux® Provided by Contractor 0.1, 1, 10, 100 g/mL 5. Performance Monitoring (if applicable). Reports are delivered electronically via secure webserver. 10. Place of Performance. The following work will be performed at the Portland VA Health Care Facility: produce DRhQ protein in a stabilizing buffer solution that incorporates our best current manufacturing procedure in our VA Portland Healthcare laboratory. The following work will be performed at the Contractor Site: preparation will be sent to carry out the Cytokine Release Assay on blood cells collected from 20 individual human donors comprised of equal numbers of males and females. 11. Period of Performance. Approximate project delivery time: 8 weeks 12. Delivery Schedule. Each test article, including DRhQ will be analyzed at 4 concentrations (TBD/ml) in undiluted whole blood with positive and negative control conditions. After incubation, plasma will be isolated and measurement of the following cytokines will be made in replicates in pg/mL: IFN , TNF , IL-2, IL-4, IL-6, IL-8 and IL-10. Using these data, a threshold (cut-point) analysis will be completed by comparing DRhQ to Erbitux (Cetuximab), which is known to elicit a low incidence of first infusion-related reactions, and to Campath (Alemtuzamab), a drug for MS which is associated with a high incidence of first-infusion reactions and can serve as a high response comparator. PDF summary report with the above detail will be provided upon assay completion. All rights to study results remain the property of the Customer. Reports are delivered electronically via secure webserver D. RESPONSE COMMITMENT I. Response: Please provide a Capability statement, and your socioeconomic status, and size classification (large business, small business, SDVOSB, VOSB, etc.). All responses should be directed to annmarie.stewart@va.gov by January 12, 2023, 10AM EST. B. Submittals furnished will not be returned to the sender. No debriefs will be conducted. Eligibility in participating in a future acquisition does not depend upon a response to this notice. C. Proprietary information is neither requested nor desired. If such information is submitted, it must clearly be marked "proprietary" on every sheet containing such information, and the proprietary information must be segregated to the maximum extent practicable from other portions of the response (e.g., use an attachment or exhibit). II. Timeline: A. This request will close on stated date within the Government Point of Entry (GPE). Note: 1. This Sources Sought is for planning purposes only, and does not constitute a commitment, implied or otherwise, that a procurement action will follow. The Department of Veterans Affairs will use the information submitted in response to this notice at its discretion and will not provide comments to any submission; however, The Department of Veterans Affairs reserves the right to contact any respondent to this notice for the sole purpose of enhancing The Department of Veteran Affairs understanding of the notice submission. 2. The content of any responses to this notice may be reflected in any subsequent solicitation, except for content marked or designated as business confidential or proprietary which will be fully protected from release outside the government. The Department of Veteran Affairs Contracting Office POC: Ann Marie Stewart Contracting Officer annmarie.stewart@va.gov