ELISA Microplate Reader Purchase

This Notice of Intent is not a request for competitive proposals. This is not a solicitation or request for offers. No solicitation package is available and telephone requests will not be honored. 6.302-1 required by statute. This acquisition is conducted under the authority of United States Code 41 U.S.C. 3304(a)(5).

The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER is testing various large molecule drug products to determine if immunogenicity of these products can be determined through in vitro, ex vivo and in vivo non-clinical assays. Testing of these samples often requires evaluation of pharmacokinetics (if in animals), cytokine levels, immunoglobulin levels and/or detection of anti-drug antibodies.

This ELISA microplate reader will replace our existing instrument which no longer functions because of software/operating system incompatibilities. To ensure comparability 0 and validity of data, we need to continue using the platform from Molecular Devices, for which we already have the software (SoftMaxPro). Importantly, this reader also allows for assessment of bacterial culture growth, which no other microplate reader currently available enables.

The Government intends to sole source to Molecular Devices, LLC., 3860 N. First Street, San Jose, CA 95134 for this requirement. Interested parties may identify their interests and capability to respond to this requirement within fifteen (15) calendar days of the publication of this notice which shall be considered by the agency. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government.

Information received will be considered solely for the purpose of determining whether or not to conduct a competitive procurement. A determination by the Government not to compete this proposed requirement based upon response to this notice is solely within the discretion of the Government. No reimbursement for any cost connected with providing capability information will be provided.