Stability Testing of LMB-100 Drug Product

Contracting Office Address The Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E138, Rockville, MD 20850, UNITED STATES DESCRIPTION The U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute (NCI), Center for Cancer Research - Laboratory of Molecular Biology plans to procure, on a sole source basis, a stability testing of the 12-month time point since manufacture of the LMB-100 drug product with Covance BioCMC, 671 South Meridian Road, Greenfield, IN 46140. The response close date of the notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(2); and, is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541380 and the business size standard is $15.0 million. The anticipated award shall be a firm fixed price type contract. It has been determined there are no opportunities to acquire green products or services for this procurement. BACKGROUND The LMB's Clinical Immunotherapy Section (CIS) runs clinical trials of recombinant immunotoxins in patients with cancer and studies issues related to these Fv-toxin molecules in the lab. Ongoing clinical trials include targeting CD22 and CD25 in patients with leukemia, lymphoma, and Hodgkin's disease with the recombinant immunotoxins HA-22 and LMB-2, both of which have induced complete remissions; and targeting mesothelin, LMB-100 on solid tumors (carcinomas). Laboratory projects deal with mechanisms of toxin effectiveness and action, and also study mechanisms and prevention of toxicity to normal tissues. LMB-100, is composed of SS1, a humanized single-chain antibody that binds tightly to mesothelin, and PE24, the translocating and ADP-ribosylating segments of the Pseudomonas exotoxin (PE) protein. PE can kill cells if it gains entry into cells. Anti-mesothelin immunotoxin LMB-100 is designed to attach to mesothelin on the cancer cells and allow entry of PE24, which will then destroy the cells. Contractor shall perform the following assays using established methods on LMB-100 drug product: Appearance (Assay BN-00010) Clarity (Assay BN-00011) pH (Assay BN-00019) UV (Assay BN-00005) Size Exclusion (Assay BN-00002) CE SDS non reduced (Assay BN-00003) iCE (Assay BN-00004) 3 Day Bioassay (Assay BN-00006) Ion Exchange (Assay BN-00007) Sub Visible Particulates (Assay BN-00013) Container Closure (Nelson Labs STP0149) Time Point Management Time Point Reporting Sample Stability Storage Technical Oversight Project Management Covance has set up the required assays for the LMB-100 Stability Program under a previous contract with our former collaborator (Selecta Biosciences), is qualified, has been audited and has validated and performed all of the assays. The government would benefit by using Covance because they can satisfy the regulatory requirements in the time frame needed at the least expense to the government. In order for a laboratory (lab) to be able to satisfy the requirements for performing the LMB-100 stability assays, it would need to transfer the unique assays to their lab. Covance is the only known vendor that has validated assays in their lab with the required Standard Operating Protocols (SOP) and have performed the assays repeatedly with their equipment and their personnel. Covance has demonstrated that the assays are reproducible, accurate and precise. To change to a different vendor which would be expensive and take several months that would be detrimental to the Government. Additionally, should a new laboratory perform the LMB-100 stability program, the Investigational New Drug (IND) application on file with the FDA would need to be modified, and the laboratory would need to be audited by a third party, another government expense. 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 11:00 AM EST, on May 9, 2019. All responses and questions must be via email to Contracting Officer, Terry Galloway, at gallowaytl@mail.nih.gov. 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 completed Representations and Certifications. Reference: NCI 5327457 on all correspondence.