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The Health and Human Services Department-Food and Drug Administration's Center for Biologics Evaluation and Research (CBER), Bethesda, MD, is seeking to find Small Business Contractors capable of (Monoclonal Antibody Production ) expanding a number of FDA-supplied hybridoma cell lines and purify the monoclonal antibody (mAb) produced by the hybridoma cell line by Protein G purification.

Please note that the small business must be responsible for providing at least 51% of the proposed services that it offers as a solution. Merely subcontracting or outsourcing the services to a large business is not an acceptable solution and the prime contractor would not qualify as a small business.

Objectives:
To expand a number of customer-supplied hybridoma cell lines, either in vivo as ascites or in vitro in culture, and purify the monoclonal antibody (mAb) produced by the hybridoma cell line by Protein G purification. For each cell line expansion and antibody purification, the final product obtained should be approximately 500 mg of purified mAb with low endotoxin and a concentration of > 4-5 mgs mAb/ml. These antibodies will be used as reagents in the development of in vitro influenza potency assays.

Scope:
To obtain large scale (~500 mgs) production of twenty (20) purified monoclonal antibodies from existing customer-supplied mAb-secreting hybridoma cell lines.

Technical Requirements:
1 - Hybridoma cells will be supplied by CBER/FDA to contractor. Contractor will expand cells either in vitro (tissue culture) or in vivo as ascites (e.g., Balb/c mice) at an appropriate scale to yield sufficient antibody for subsequent Protein G purification.

2 - Antibody from ascites or tissue culture will be purified by Protein G chromatography to yield a final product of ~500 mg mAb with low endotoxin and a concentration of > 4-5 mgs mAb/ml in an isotonic buffer (e.g., PBS). Purified antibody will be supplied to CBER/FDA in ~200 vials containing ~2.5 mgs mAb (0.5 ml).

3 - Three vials of hybridoma cells from each expanded cell line will be returned to CBER/FDA.

Deliverables:
For each of the twenty (20) antibody production projects, purified mouse monoclonal antibody (~500 mg mAb, low endotoxin, > 4-5 mgs mAb/ml) will be provided by the contractor to CBER/FDA.

Place of Performance:
Work will be performed at the location of the contractor.

If you are a small business concern under NAICS CODE 541380 - Testing Laboratories; Size standards $12 million and believe that your firm would be able to provide the FDA the services as described, please submit an e-mail to [email protected]. The vendor should include information about their company, as well as demonstrate they have experience providing these services in the local area.

Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement(s) similar to this one should be set aside for small business or made available to full and open competition.

The DEADLINE for receiving responses is 1:00 p.m. Central Time, May 1, 2013. Responses received after the deadline or without the required information shall be considered unacceptable and shall not be considered. Responses should be emailed to [email protected] and the email subject line should reference Sources Sought FDA_117782. Since this is a sources sought announcement, no evaluation letters will be issued to the participants.