Tobacco Plant Production of Stoichiometric Bioscavengers

Research and Development Sources Sought Topic: Tobacco Plant Production of Stoichiometric Bioscavengers. Background The Joint Science and Technology Office (JSTO) of the Defense Threat Reduction Agency (DTRA) is interested in stoichiometric butyrylcholinesterase (BChE) bioscavenger technologies that would eventually become an FDA licensed product designed to protect the Warfighter against multiple organophosphorus nerve agents (OPNAs). To date this is the only protein that demonstrates the desired efficacy against all nerve agent target tested so far by irreversibly binding OPNAs on a one to one molar targets basis. BChE can be isolated and purified from a human source (HuBChE), however, current manufacturing capabilities are limited by high cost as well as limited availability of starting material. Furthermore, the product requires administration of large quantities (hundreds of milligrams) to confer protection against modest levels of OPNAs at prohibitive costs per dose. Manufacturing capabilities to isolate and purify BuChE from non-human matrices are sought to provide a larger availability of starting materials and potentially lower costs per dose. Furthermore, capabilities developed have to be convertible to current good manufacturing practices (cGMP). Capability Sought The respondent must have demonstrated and shall communicate its experience for the large scale production and delivery of HuBChE from tobacco plant materials in accordance with the following criteria: 1.Protein purity of > 99% as measured by SDS PAGE (reduced and non-reduced) 2.Specific activity ≥ 653 U/mg measured by the Ellman procedure 3. Tetramer content ≥ 94.5 % determined by size exclusion chromatography 4.Glycoslyation of 8-9 sites as determined by mass spectrometry 5.Sialic acid terminal occupation ~70% as determined by mass spectrometry Response Instructions Respondents shall address the information described above (and any additional information the respondent shall deem appropriate) via a Capabilities Statement (five-page limit) in Microsoft Word format. A rough order of magnitude (ROM) cost estimate for the services outlined above over a three-year period shall be provided. In addition, respondents shall include their name, address, CAGE code, and DUNS, and submit company size standard under the 541711 NAICS code. The information shall be submitted via e-mail to [email protected] and [email protected] with a cc: to [email protected]. Hard copy submissions will not be accepted. Submissions shall be submitted no later than 2:00pm local Ft. Belvoir time on 21 April 2016. Disclaimer This Sources Sought notice is solely for the purpose of gathering information and does not constitute a solicitation or the issuance thereof. Unless otherwise stated herein, no additional information is available. Requests for same will be disregarded. All information received in response to this notice that is marked proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Any information submitted will not be returned, and no payment will be made by the Government for such information. No formal RFPs or other solicitations regarding this announcement are available at this time. Information provided herein is subject to change and in no way binds the Government to solicit for proposals or award contracts. It is the respondent's responsibility to monitor FedBizOpps at http://www.fbo.gov for the release of any subsequent information. Primary Point of Contact: Peter M. Falk, PhD [email protected]