National Cancer Institute (NCI), Center for Cancer Research (CCR), Vaccine Branch Clinical Trials Team plans to procure cGMP Keyhole Limpet Hemocyanin (KLH), on a sole source basis, from Stellar Biotechnologies, Inc. of 332 E. Scott St., Port Hueneme, CA 93041.

This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1 (b)(2) and 13.501-(a)(1) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 325414 and the business size standard is 1,250 employees. 

It has been determined there are no opportunities to acquire green products or services for this procurement.

The Vaccine Branch Clinical Trials Team operates the protocols involving dendritic cell (DC) vaccine which is a personalized approach to treat cancer using patients' own immune cells harnessed by laboratory method to identify the cancer cells better.

The Team in urgent need of cGMP Keyhole Limpet Hemocyanin (KLH) for use in the preparation of autologous (patient's own) DC vaccines made in the Cell Processing Section (CPS) of the Clinical Center Department of Transfusion Medicine (DTM) for administration to patients in ongoing cancer vaccine clinical trials.

KLH, a glycosylated vaccine carrier protein is essential in the manufacturing of DC vaccines to provide adequate immunologic process and cannot be made without this reagent. The Team uses DCs transduced with an Ad5f35-HER2ECTM construct, a modified adenovirus for the former and pulsed with TARP peptides for the latter which is a part a part of IND. Current inventory of KLH in Pharmacy does not allow any further accrual for the protocols.

KLH previously used in the NIH for clinical work across institutes has always been manufactured by Stellar Biotechnologies as they are the sole source for this cGMP superior product.  There is evidence of clinical benefit from both vaccine platforms, with no serious patient adverse events or culture contamination, and therefore want to continue to use KLH from the same source, Stellar Biotechnologies. Their clinical grade high molecular weight (HMW) KLH has resulted in excellent final DC vaccine products that meet specified release criteria.

Stellar Biotechnologies, Inc. is the only source for a scalable supply of cGMP-grade HMW-KLH for vaccine manufacture. Recently Sigma-Aldrich sold the product manufactured by Stellar, however now Stellar sells the product directly. To maintain consistency with the treatment in ongoing cancer vaccine trials, consistency of the KLH is required. 

This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 3:00 PM ET, on June 11, 2018. All responses and questions must be via email to Miguel Diaz, Contracting Officer at [email protected]. A determination by the Government not to compete this proposed requirement 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 be registered and have valid certification through SAM.GOV and have Representations and Certifications filled out. Reference: N02RC85016-45 on all correspondence.