SPECIAL NOTICE
Q -- Metarrestin Storage and Stability Testing Services
- Notice Date
- 7/24/2023 7:48:10 AM
- Notice Type
- Special Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- NIH NCI Bethesda MD 20892 USA
- ZIP Code
- 20892
- Response Due
- 8/4/2023 9:00:00 AM
- Archive Date
- 08/19/2023
- Point of Contact
- Miguel Diaz, Phone: 2402765439
- E-Mail Address
-
miguel.diaz@nih.gov
(miguel.diaz@nih.gov)
- Description
- DESCRIPTION National Cancer Institute (NCI), Center for Cancer Research (CCR) plans to procure, on a sole source basis, laboratory testing from Societal CDMO San Diego, LLC 6828 Nancy Ridge Drive, Suite 100, San Diego, CA 92121. 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)(1)(i) using simplified acquisition procedures for commercial acquisitions.� The North American Industry Classification System code is 325412 and the business size standard is 1,250 employees. BACKGROUND The National Cancer Institute�s (NCI�s) Center for Cancer Research (CCR), National Institutes of Health (NIH), aims to improve the lives of all cancer patients by solving important, challenging and neglected problems in cancer research and patient care. The NIH National Center for Advancing Translational Sciences (NCATS) aims to turn research observations into health solutions through translational science. CCR�s Pediatric Oncology Branch (POB) is dedicated to improving outcomes for children and young adults with cancer and genetic tumor predisposition syndromes. POB conducts translational research that spans basic science to clinical trials. Previous studies suggest that the chemical compound Metarrestin can reduce the physiologic toll of metastasized cancer. The NCATS Bridging Interventional Development Gaps (BrIDGs) program has been supporting the development of Metarrestin drug product ML-246 (method validation, formulation development, and stability studies of the drug product as capsules). 1 mg capsules (lot 18ME083) and 5 mg capsules (lot 18ME083) were manufactured in December 2018 by the vendor Irisys LLC (now Societal CDMO San Diego, LLC), and are since then in a stability program with the manufacturer. FDA approved the Investigational New Drug (IND) application and a clinical phase 1 study was initiated (NCI clinical protocol 20-C-0023). However, COVID-19 pandemic prevented clinicians to recruit study patients. Thus, further stability studies are required because the drug products are getting more aged and must be tested during the full duration of the clinical study to stay in compliance with FDA regulations. OBJECTIVE The objective of this delivery order is to provide of stability testing of Metarrestin from two (2) different production lots, 18ME083 (1 mg capsules) and 18ME085 (5 mg capsules). Stability testing shall take place at 60, 66, and 72 months (60M, 66M, and 76M) after date of manufacture of these production lots. SCOPE / TASKS Independently, and not as an agent of the Government, the Contractor shall furnish all necessary labor, materials, supplies, equipment, and services not otherwise provided by the Government. The Contractor shall perform the following tasks in accordance with their FDA-approved stability test protocol SS-196: Task 1 � Sample Storage The Contractor shall continuously store the samples in its -20�C dedicated temperature and humidity controlled stability chambers. Samples shall only be removed for testing. Task 2 � 60M Testing Conduct �Test Scheme A� of protocol SS-196 for both capsule production lots, 18ME083 and 18ME085, at time point 60M after manufacture. This characterization shall include: Per protocol method QC-019, deviations from the following appearances shall be noted: Dosage form: transparent (natural color) capsules with pharmaceutical coil; package in a child-resistant sealed white plastic bottle. Liquid content: transparent and yellowish. A Karl Fischer moisture content sample shall be used. Per protocol method QC-305, the following shall be confirmed: Assay: to be within 90% to 110% of label claim. High-performance liquid chromatography (HPLC) retention time to be within 5% of the Metarrestin reference standard, Related substances/impurities: Report value (% area) and Relative Retention Time (RRT) of each impurity to be at or less than 0.2%. Report sum of all individual impurities at or above 0.2% and not more than 2%. Per protocol method QC-311: to confirm dissolution of 80% or more at 45 minutes. Per protocol method EQ-105: to measure moisture content (Karl Fisher titration) Conduct �Test Scheme B� of protocol SS-196 for both production lots, 18ME083 and 18ME085, at time point 60M after manufacture. This characterization shall include: Per protocol method USP: Total Aerobic Microbial Count (TAMC; specification: 103 CFU/g) Total Combined Yeasts and Molds Count (TYMC; specification: 102 CFU/g) Per protocol method USP: Escherichia coli (specification: absent) Deliver the intermediate analysis results to POB�s TPOC by email. Task 3: 66M Testing The Contractor shall conduct �Test Scheme A� of protocol SS-196 for both capsule production lots, 18ME083 and 18ME085, at time point 66M after manufacture. The intermediate analysis results shall be delivered to the TPOC by email. Task 4: Final 72M Testing The Contractor shall conduct �Test Scheme A� and �Test Scheme B� of protocol SS-196 for both capsule production lots, 18ME083 and 18ME085, at time point 72M after manufacture. The final analysis results shall be delivered to the TPOC by email. GOVERNMENT RESPONSIBILITIES The Government Technical Point of Contact (TPOC) will coordinate with the Contractor to deliver samples to the Contractor�s facilities. Samples will be shipped no later than 45 calendar days after award. The Government will be responsible for arranging shipment of samples to and from the Contractor. TYPE OF ORDER This is a firm fixed price delivery/task order for non-severable services. PERIOD OF PERFORMANCE The period of performance shall be for 8 months from date of award. PLACE OF PERFORMANCE Work shall be performed at the Contractor�s facilities. REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE Pursuant to FAR clause 52.212-4, all work to be delivered under this delivery order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the Technical Point of Contact (TPOC), who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor. POB Technical Point of Contact: TBD upon award. The deliverables shall be provided to the NCI TPOC as downloadable PDF through a secured link; this link shall be provided to the TPOC via email. NCI shall have 30 days in which to review and accept the deliverables provided by the Contractor. If no comments or request for revisions are provided within 30 days, the deliverables shall be considered acceptable. Deliverable Deliverable Description / Format Requirements Due Date Deliverable 1 (TASK 1) Certified Analysis Report (PDF) for Metarrestin lots �#18ME083 and #18ME085, 60M after date of manufacture; to include results from Test Scheme A (QC-19, QC-305, QC-311, EQ-105) and from Test Scheme B (USP and USP) No later than 62 months after date of manufacture Deliverable 2 (TASK 2) Certified Analysis Report (PDF) for Metarrestin lot #18ME083 and #18ME085, 66M after date of manufacture; to include results from Test Scheme A (QC-19, QC-305, QC-311, EQ-105) No later than 68 months after date of manufacture Deliverable 3 (TASK 3) Certified Analysis Report (PDF) for Metarrestin lot #18ME083 and #18ME085, 72M after date of manufacture; to include results from Test Scheme A (QC-19, QC-305, QC-311, EQ-105) and from Test Scheme B (USP and USP) No later than 74 months after date of manufacture 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 capability statement 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 12:00 PM ET, on August 04, 2023.� All responses and questions must be via email to Miguel Diaz, Contracting Officer at miguel.diaz@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 the System for Award Management, SAM.gov, and have their Representations and Certifications completed. Reference: 75N91023Q6688366 on all correspondence.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/91c5c0cc0fa04af09cbf7c7144676438/view)
- Record
- SN06760129-F 20230726/230724230047 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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