Inactive

The Food and Drug Administration intends to make a sole source award for a Automated High Throughput Lab-Scale Instrument for Solid-Phase Synthesis and Purification of RNA/DNA. The award will be made ... The Food and Drug Administration intends to make a sole source award for a Automated High Throughput Lab-Scale Instrument for Solid-Phase Synthesis and Purification of RNA/DNA. The award will be made to: Bio Technic Services, Inc 590 Over Ridge Dr. Frederick, MD 21703 In accordance with FAR 6.302-1, FAR 13.106(b) and FAR 5.203, Only one responsible source and no other supplies or services will satisfy agency requirements. The FDA requires a proposed high-throughput instrument to produce a continuous manufacturing system for nucleic acid-based drugs and to reduce the inherent process-related impurities in HPLC techniques currently used to for purification of synthetic nucleic acid sequences. The need for the proposed instrument is based on its potential ability to manufacture and deliver synthetic DNA and/or RNA sequences of unmatched purity in a continuous manner to ultimately improve the availability of highly pure nucleic acid-based drugs to patients. The proposed project is a continuation of a current contract undertaken with Bio Technic Services, LLC. The services and supplies are only available from the original source in this follow-on contract for the sake of the continued development of this highly specialized innovative equipment. Award to any other source will result in substantial duplication of cost to the government that is not expected to be recovered through competition and can potentially result in delays in fulfilling the FDA’s requirements. Bio Technic Services, LLC is highly qualified for the successful execution of the current and proposed contracts for constructing an automated high-throughput system for synthesis and purification of DNA and/or RNA sequences. This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within fifteen (15) days after the publication of this synopsis which shall be considered by the agency. Responses received after 15 days or without the required information may not be considered. For information concerning this acquisition contact: Nikola Zuber Contract Specialist Nikola.Zuber@fda.hhs.gov (301) 796 - 9671