Procurement of Retronectin for the production of genetically modified PBL for adoptive cell transfer protocols

Title:  Procurement of Retronectin for the production of genetically modified PBL for adoptive cell transfer protocols

Notice Number: N02RC42589-62

Proposed Posted Date:  August 8, 2014

Proposed Response Date:  August 23, 2014

Classification Code: 6505

NAICS Code: 325414

 Small Business Size Standard: 500

Contracting Office Address:

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room1E144,Bethesda, MD 20892 USA.

Description:

The National Cancer Institute (NCI), Center for Cancer Research (CCR) plans to procure on a sole source basis with Clontech Laboratories Inc., located at 1290 Terra Bella Ave. Mountain View, CA 94043 for Retronectin for the production of genetically modified PBL for adoptive cell transfer protocols.

The products herein are being procured in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1 (b) (1).  The North American Industry Classification System Code is 325414 and the business size standard is 500. 

Only one award will be made as a result of this solicitation.  It will be awarded as an indefinite delivery indefinite quantity contract (IDIQ) with firm fixed price task orders.

It has been determined that there is no opportunity to acquire green products or services under this procurement.

Period of Performance: Base period of five years of the IDIQ parent award.

The surgery Branch of the National Cancer Institute (NCI) has pioneered the use of adoptive cell transfer therapy for the treatment of advance metastatic cancer. The purpose of this acquisition is to expedite the purchase of one reagent used in manufacturing genetically modified T cells used in these therapies.

Retronectin is an essential reagent used to tranduce human T cells with retroviral gene transfer vectors. The FDA mandates that GMP (Clinical grade) retronectin is used in the manufacture of genetically modified cell products for the treatment of human diseases. This acquisition will facilitate the manufacturing of personalized cell based therapies for patients with cancer on short notice.

The contractor shall be able to provide the following:

·       (10) 2.5 mg of Retronectin six times annually

To NCI’s knowledge Clontech laboratories is the sole provider of GMP grade Retronectin and have a master file registered with the FDA. The FDA mandates use of GMP grade Retronectin for clinical trials. NCI clinical trials have been validated using this product and revalidation would be needed if the products were substituted.

This is not a solicitation for competitive quotations.  However, if any interested party, especially a small business, believes they can meet the above requirement, they may submit a proposal. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein.  The proposal must be received at the NCI Office of Acquisitions on or before 11:00 AM EST on August 23, 2014.  All responses and questions must be in writing and can be faxed (301) 402-4513 or emailed to Tiffany Kittrell, Contract Specialist at Tiffany.kittrell@nih.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice 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. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov.  No collect calls will be accepted.  Please reference solicitation number N02RC42589-62 on all correspondences.