Sources Sought Notice: Monoclonal Antibody Synthesis

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is conducting market research to support the Center for Drug Evaluation and Research (CDER) requirement to obtain monoclonal antibody synthesis services and resultant drug substance mAb.

This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the required supply item/services. This notice is for planning purposes only, and does not constitute an invitation for Bids, Request for Proposal or Request for Quotation or an indication the Government will 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.

Minimum Requirements:

The contractor shall be capable of providing thirty (30) grams of monoclonal antibody and process data, meeting or exceeding the salient characteristics described below:

1. The cell-line shall be used for the material supply will be one of the CHO expression cell-lines used at the CDER. Depending on the preference, a cell-line will be chosen.
2. Cell-culture shall be done with shake-flask for seeding and 5L bioreactor for production. Daily samples shall be taken for cell-counting and metabolic profiles.
3. Daily cell-culture samples shall be taken for analytical testing. Cedex-Hires and NOVA Bioprofile or any instrument that monitors metabolites, relative gas content and pH of the culture media shall be used. Titer samples shall be taken at harvest. Purity samples shall be taken during chromatography run.
4. The downstream processing shall be done to meet 95% or more purity specification.
5. The mAB expression shall be at least 1 g/L or greater
6. 3 batches of 3.5L working volume bioreactor shall generate approximately 10.5 g of mAB.
7. CD FortiCHO  or any other chemically defined media suitable for CHO cell culture shall be used for cell-culture.
8. PTFR 0.2 micro-meter 50 mm filter shall be used
9. Nalgene filtering flask of 500 mL shall be used for media filters.
10. Default media shall be added with L-glutamine, anti-form, and pen/strep

Capability Statements:

Responses to this sources sought shall unequivocally demonstrate the respondent’s capabilities to provide the services/antibodies described above. Though the target audience is small business, all interested parties may respond. At a minimum, responses shall include the following:

1.      Business name and bio, 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. Provide this same information again if responding to provide a service offered by another firm.

2.      Past Performance information shall include date of services, description, dollar value, client name,

3.      Client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include DUNS number and size status) if not the respondent.

4.      Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing.

5.      If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and Schedule Item Numbers (SIN)s that are applicable to this potential requirement are also requested. If a large business, clarify if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.

Response Instructions:

Interested parties shall respond with capability statements in person, by e-mail, fax, mail or other delivery method before 3:00 PM Eastern Time on March 8th, 2017 to [email protected].

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).