Inactive Total Small Business Set-Aside (FAR 19.5)

The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to StemCell Technologies for procurement of Semi-solid culture medium. The Government intends to issue a sole source awar... The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to StemCell Technologies for procurement of Semi-solid culture medium. The Government intends to issue a sole source award in accordance with FAR 6.302-1, only one responsible source and no other will satisfy the agency requirements for the above stated equipment. The manufacture of therapeutic proteins and their variants require semi-solid medium to supports cell growth and the synthesis of the recombinant proteins, which are used to select rare, high producing CHO cells. The FDA laboratory has been qualified for semi-solid culture medium using ClonaCell products for the laboratory-scale production process. As the FDA laboratory has established protocols and qualifications, FDA intends to continue with existing semi-solid media formulation to avoid delays and reduce risk in cell line development and manufacture of therapeutic protein variants for testing potential safety and quality issues with drug products. Furthermore, alternative semi-solid media tests resulted in manufacturing issues. Therefore, this acquisition is to purchase existing semi-solid medium formulation from StemCell Technologies. StemCell Technologies is the sole source provider of the ClonaCell products: ClonaCell-CHO CD Medium and ClonaCell-CHO CD Liquid Medium. ClonaCell-CHO CD Medium is of proprietary formulation. This will be a firm fixed price award. The NAICS Code is: 334516 Analytical Laboratory Instrument Manufacturing StemCell Technologies Inc 2323-222 Third Street Cambridge, MA 02142 This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement to Sarah Hussain, sarah.hussain@fda.hhs.gov in writing and must be within 7 days after date of publication of this notice which may be considered by the agency. A determination by the Government not to compete as a result of information received is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No phone calls will be accepted.