MODIFICATION
65 -- 130 grams of cGMP-grade Q-Griffithsin (Q-GRFT)
- Notice Date
- 8/3/2020 8:45:41 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325411
— Medicinal and Botanical Manufacturing
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95020Q00202
- Response Due
- 8/10/2020 8:59:00 AM
- Archive Date
- 08/14/2020
- Point of Contact
- Kimberly Espinosa, Phone: 301-827-3546
- E-Mail Address
-
kimberly.espinosa@nih.gov
(kimberly.espinosa@nih.gov)
- Description
- 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. 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. This requirement includes the following items: Line Item 1: Qualification Report on Seed and Virion Banks Line Item 2: Report on the mature, transduced Nicotiana plants Line Item 3: 130 grams of current Good Manufacturing Practice (cGMP)-grade Q-GRFT, with a Quality Assurance (QA)-approved Certificate of Analysis. Line Item 4: 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. See attached RFQ and RFQ attachments for complete details.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/7420c6388d234828acd07ec4d9764754/view)
- Record
- SN05742559-F 20200805/200803230141 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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