130 grams of cGMP-grade Q-Griffithsin (Q-GRFT)
Description This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: ... Description This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Please note that to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the cost of contract performance incurred for personnel must be expended for employees of the small business awardee (see FAR 52.219-14 Limitations on Subcontracting). Background The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), with a mission to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The NCATS Therapeutic Development Branch (TDB) forms collaborative research partnerships with external investigators with the goal of “de-risking” therapeutic candidates and novel technologies to make them more attractive for adoption by outside business partners. TDB is collaborating with research partners from the University of Louisville Research Foundation (ULRF) to develop Q-GRFT (a proprietary therapeutic protein developed by ULRF) as a preventative therapeutic against SARS-CoV-2 infection in humans. Q-GRFT is a recombinant protein, produced in Nicotiana benthamiana host plants in gram quantities using a tobacco mosaic virus (TMV) vector containing Q-GRFT cDNA. Project requirements NCATS requires 130 grams of current Good Manufacturing Practice (cGMP)-grade Q-GRFT for further preclinical and clinical studies. The Q-GRFT drug substance (DS) is a recombinant protein variant of Griffithsin (GRFT) dissolved in phosphate buffered saline (PBS). The DS is produced in Nicotiana benthamiana host plants inoculated with a recombinant Tobacco Mosaic Virus (TMV) vector carrying Q-GRFT cDNA. Mature plants expressing Q-GRFT are harvested and plant biomass is homogenized to a green slurry to extract and precipitate proteins. The slurry is clarified and the Q-GRFT active pharmaceutical ingredient is chromatographically purified and suspended in PBS. The Contractor must have the following capabilities: 1. To germinate and propagate Nicotiana plants from a qualified seed lot under strictly controlled growth conditions (68-76 F; 16:8 hour light/dark schedule; 25 +/- 3 days), transplanting seedlings as plants develop to ensure sufficient space to grow prior to inoculation. 2. To inoculate host plants with Q-GRFT cDNA plasmids, using a qualified TMV virion bank, via high-pressure spray. 3. To continue growth of inoculated plants for 12-14 days under these same controlled conditions. 4. To generate and harvest sufficient total plant biomass (350 kilograms, minimum) to provide enough raw material to obtain the necessary amount of transiently-expressed Q-GRFT (130 grams) in a single lot. 5. To harvest and homogenize the plant biomass and filter press the green slurry to a green juice. 6. To purify the green juice by chromatography / reverse phase chromatography, and ultrafilter / diafilter the final Q-GRFT DS into polyethylene terephthalate glycol (PETG) containers. Deliverables include: 1. 130 grams of current Good Manufacturing Practice (cGMP)-grade Q-GRFT 2. Periodic progress reports throughout the manufacturing process 3. A Quality Assurance (QA)-approved Certificate of Analysis for the cGMP batch, and 4. A Chemistry, Manufacturing and Controls (CMC) report in the electronic Common Technical Document (eCTD) format utilized by the US Food and Drug Administration (FDA) for regulatory filings. Additional Information The Contractor must have all of these capabilities in-house to ensure compliance with critical manufacturing and process controls to monitor consistent manufacture of DS according to identified quality criteria. Subcontracting tasks and transferring intermediate materials to another vendor(s) creates risks to those materials and could add significant delays to the overall production schedule. Plants must be maintained at specific controlled growth conditions from seeding, through inoculation, until harvest, and cannot be shipped between sites at any time during the growing stages. The Contractor must be able to process the full harvested biomass (350 kilograms) from solid to slurry to juice. At harvest, if plants show any signs of deterioration or decay, that tray and surrounding plants must be removed before processing. Shipping the remaining biomass to another vendor for processing risks the integrity of the remaining plant material (e.g., due to environmental degradation or physical loss of a shipping lot), putting the final yield of Q-GRFT in jeopardy. The process of extraction and purification from green juice to final DS includes multiple in-process control (IPC) sampling steps to ensure quality control. Contract Type and Anticipated Period of Performance / Delivery Date The Government anticipates awarding a firm fixed-price contract under a future solicitation. The anticipated delivery date is six (6) months after the date of award, but is dependent on the timeline and capability of the awardee. Submission Instructions and Due Date Written capability statements must be submitted via email by 11:59am Eastern on Thursday, July 23, 2020 to Kimberly Espinosa, Contracting Officer, at Kimberly.espinosa@nih.gov. Written capability statements should demonstrate your organization’s in-house ability and related experience with manufacturing cGMP Q-GRFT, and address the required capabilities listed under Project Requirements above. All capability statements must provide the following: (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant the applicable NAICS code. 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 should 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 should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Data sourced from SAM.gov.
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