Pilot Scale Non-cGMP Manufacturing of Protein Based Medical Countermeasures

Background The Joint Science and Technology Office (JSTO) of the Defense Threat Reduction Agency (DTRA) currently funds research efforts to develop bioscavengers to protect the Warfighter against multiple organophosphorus nerve agents (OPNAs). To date, only one protein, human Butyrylcholinesterase (HuBChE), demonstrates the desired efficacy against all desired nerve agent target tested so far by binding OPNAs stoichiometrically on a one to one molar basis. Ongoing preclinical bioscavenger programs require high quality HuBChE as a standardized control, yet this protein is only available in limited quantities at high cost. Therefore, DTRA/JSTO is conducting market research in an effort to identify all potential sources with the capability to provide an efficient process for producing highly pure (98%) HuBChE for delivery in the quantity of 1.0 to 1.5 grams per month. This standardized material will enable ongoing recombinant and catalytic protein Medical Countermeasures (MCM) development research. Capability Sought The Respondent shall communicate its capability for the production and delivery of HuBChE in accordance with the following criteria: 1. Product will be highly pure (>98%) HuBChE predominantly in tetrameric form. 2. Production yields will be > 5 grams of enzyme per 80 kg of Cohn Paste. 3. Product will be provided in buffered solution form (non-lyophilized) at a concentration of 25 mg/mL with no preservatives. 4. Product will be delivered as 1.0 mL aliquots in 2 ml glass vials. Vials will be sealed under nitrogen gas. 5. Monthly delivery will be 40-60 vials (equivalent to 1.0g-1.5g total protein). 6. Product will be maintained at 4'C (not frozen). 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 ayodele.o.olabisi.mil@mail.mil with a cc: to brian.d.nuckols.civ@mail.mil. Hard copy submissions will not be accepted. Submissions shall be submitted by no later than 2:00 pm local Ft. Belvoir time on September 14, 2015. Disclaimer This Sources Sought notice is solely for the purpose of gathering information and does not constitute a solicitation or the issuance thereof. 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. DTRA is accepting questions regarding this notice but will not be providing responses. Primary Point of Contact: LCDR Ayodele Olabisi S&T Manager Chemical/Biological Technologies Department Defense Threat Reduction Agency ayodele.o.olabisi.mil@mail.mil