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Sources Sought Notice - Development and Efficacy Testing of a 405 nm High-Intensity Narrow-Spectrum (HINS)-light Prototype System for Pathogen Reduction of Blood Components

June 30, 2014



Sources Sought Notice - Development and Efficacy Testing of a 405 nm High-Intensity Narrow-Spectrum (HINS)-light Prototype System for Pathogen Reduction of Blood Components

Notice Type: Sources Sought Notice

Posted Date: 27-JUN-14

Office Address: Department of Health and Human Services; Food and Drug Administration; Office of Acquisitions and Grants Services; 3900 NCTR Road, HFT-320 Bldg 50 | Rm 421 Jefferson AR 72079

Subject: Development and Efficacy Testing of a 405 nm High-Intensity Narrow-Spectrum (HINS)-light Prototype System for Pathogen Reduction of Blood Components

Classification Code: B - Special studies and analysis - not R&D

Solicitation Number: FDA1135193

Contact: Regina R. Williams, Contract Specialist, Phone (870) 543-7012, Fax (870) 543-7990, Email regina.williams@fda.hhs.gov

Description: Department of Health and Human Services

Food and Drug Administration

Office of Acquisitions and Grants Services

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Review (CBER) Division of Hematology (DH) Laboratory of Cellular Biology requirement for Development and Efficacy Testing of a 405 nm High-Intensity Narrow-Spectrum (HINS)-light Prototype System for Pathogen Reduction of Blood Components. This is a Sources Sought Notice to determine the availability and capability of small businesses that can provide Development and Efficacy Testing of a 405 nm High-Intensity Narrow-Spectrum (HINS)-light Prototype System for Pathogen Reduction of Blood Components set forth herein. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals or Request for Quotation, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The associated North American Industry Classification System (NAICS) code is 541711-Research and Development in Biotechnology; Small Business Size 500 employees.

Statement of Work Background Microbial contamination of ex vivo stored human blood components is a major safety concern in transfusion medicine, resulting in discarding of the products, and health risks for recipients of contaminated donor blood.

Current pathogen reduction technologies (PRT) rely on the use of solvent extraction or photo-inactivation methods to reduce microbial contamination in blood and blood components, however there are major disadvantages in that these methods can produce photo-adducts and other breakdown products that lead to neo-antigenicities of the PRT-treated blood products in addition to damaging the products.

Concerns about PRT-treated blood component quality and toxicity, in addition to reported adverse events, have limited the routine use of PRT worldwide. The transfusion medicine field is therefore in critical need of novel proof-of-concept ideas for pathogen reduction in order to facilitate the manufacturing of safer products to the end users.

Statement of Need The Food and Drug Administration's(FDA) Center for Biologics Evaluation and Review (CBER) Division of Hematology (DH) Laboratory of Cellular Biology, has a requirement to Development and Efficacy Testing of a 405 nm High-Intensity Narrow-Spectrum (HINS)-light Prototype System for Pathogen Reduction of Blood Components.

Performance Requirements Tasks: 1. Evaluation of the optical characteristics of RBCs. The absorbance and transmission values of 405 nm light through RBCs shall be determined by spectrophotometric analysis, and results shall be used to determine the penetrability of 405 nm light through differing depths of RBC suspensions. Fluorescence spectrophotometry shall also be used to determine whether the RBC, or any internal component of the RBCs, can be photo-excited by 405 nm photons, and potentially act as endogenous photosensitizers to enhance pathogen inactivation. Characterisation of the optical characteristics of the RBCs shall facilitate optimisation of the light exposure system to be developed for initial treatment of 10 mL in 6-well cell culture plates, and subsequent treatments of RBC in storage bags used for transfusion.

2. Determination of an 'upper treatment limit' to which platelet suspension can be exposed. Results from the previous project demonstrated that use of low irradiance levels can be successfully applied to achieve decontamination, whilst having no detrimental effect to the platelet suspensions. Exposure tests shall be performed using high irradiance light to achieve rapid decontamination of whole transfusion bags in order to determine if there is an upper exposure limit to which the platelet cells can be safely exposed. This shall be conducted through antimicrobial efficacy testing of high irradiance light (~100 mWcm-2) for whole-bag decontamination, and inactivation kinetics will be compared against those achieved using low-irradiance (FDA laboratories to determine the compatibility of platelets treated with high-irradiance light for transfusion through in vivo murine studies.

3. Additional investigations on effects of 405 nm light on the physiological status of blood components. Analysis of treated blood components will be conducted using a range of tests including: microscopic visualisation of cells to detect any major morphological changes of light-treated components; biochemical analysis and pH measurements of treated components in order to detect cell lysis, leakage of cell contents or changes in composition. [As with the platelets, if initial studies on the decontamination efficacy and the pysiological status of treated RBCs prove successful, potential follow-on studies could be conducted at the FDA laboratories to determine the compatibility of light-treated RBCs for transfusion through in vivo murine studies.]

4. Investigate the effect of 405 nm HINS-light for decontamination of bacteria in RBC suspensions. Blood components shall be artificially seeded with problematic microbial contaminants, and the bactericidal effect shall be explored. Initial studies aim to generate evidence of the bactericidal effects using low volume, low-depth RBC samples, with investigations progressing to treatment of full transfusion bags, if results are successful. Inactivation kinetics shall be generated by determining levels of contamination in the blood products pre- and post-treatment.

5. Development and efficacy testing of a prototype device for decontamination of transfusion bags. Upon establishment of the 'upper' safe limits for platelet exposure, a prototype system shall be designed and developed. To facilitate the design process, discussion with clinical end users will be initiated in order to establish the preferable mode of operation (e.g. rapid versus overnight treatment; single versus multi-bag treatment systems, etc). Design of the device shall involve analysis and optimisation of a number of parameters including: (i) electrical input; (ii) optical output; (iii) optical profile of light sources; (iii) antimicrobial efficacy; (iv) system agitation & other operational features; (v) energy efficiency.

6. Preparation of an interim and a final report to FDA/CBER on results of confirmatory findings, and preparation of a paper for publication in a peer-reviewed scientific journal.

Period of Performance: Twelve (12) months from contract award

Place of Performance: Contractor's Location

Respondents shall furnish sufficient information necessary for the Government to conclusively determine capability to provide the requirements identified above to include three (3) references for the same or similar services within the last two years to include name, telephone number, mailing address, email address, contract number and description of services to include dollar amount. Additionally, provide Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement.

The government is not responsible for locating or securing any information, not identified in the response.

Interested Parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before July 5, 2014 by 12:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, Office of Acquisition & Grants Services, Field Operations Branch, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email regina.williams@fda.hhs.gov. Reference FDA1135193.

Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice shall ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality. No proprietary, classified, confidential, or sensitive information shall be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."

Link/URL: https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1135193/listing.html


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