This is a Sources Sought Notice (not a request for either a quote or proposal, nor an invitation for bid). The intent of this notice is to conduct a market survey to identify potential firms to develop and manufacture human or human compatible monoclonal antibodies (mAbs) as therapies for type A botulinum neurotoxins. Services required include: 1) development and production of cGMP master and working cell banks; 2) process development, manufacture of non-GMP pilot lots, manufacture of cGMP bulk drug substance (5-10 grams); 3) preparation of chemistry, manufacturing, and control data; and 4) demonstration of potency of monoclonal antibodies in a standardized mouse bioassay. Prospective firms are encouraged to submit a capability summary that does not exceed 3 pages in length describing firm’s related experience and the approach in meeting the requirements stated above. Please note that this notice is not to be construed as a commitment by the Government. The Government will not pay for any costs associated with providing information in response to this notice and any follow up information requests. Capability statements addressing the above requested information should be submitted by COB August 19, 2004, to Liem T. Nguyen, Contract Specialist, CMP, NIAID, NIH, by email ([email protected]). No telephone inquiries will be accepted.

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