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 manufacture approximately 50g of a recombinant type E botulinum neurotoxin vaccine. 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 [approximately 50 grams, a portion of which, 2000 doses, will be formulated with adjuvant and vialed, the remainder will be retained as Bulk Drug Substance]; 3) preparation of chemistry, manufacturing, and control data; and 4) demonstration that the cGMP vaccine protects against lethal challenge from at least 1,000 mouse IPLD50 of type E botulinum neurotoxin in at least one standardized mouse potency assay. 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 30, 2004, to Liem T. Nguyen, Contract Specialist, CMP, NIAID, NIH, by email ([email protected]). No telephone inquiries will be accepted.

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