SOLICITATION NOTICE
Q -- Accelerated Stability Testing of SS1P Immunotoxin Drug Product
- Notice Date
- 6/6/2012
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-120081-MD
- Archive Date
- 7/6/2012
- Point of Contact
- Miguel Diaz, Phone: (301) 402-4509, Caren N Rasmussen, Phone: (301) 402-4509
- E-Mail Address
-
miguel.diaz@nih.gov, cr214i@nih.gov
(miguel.diaz@nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Boulevard, EPS Suite 600, Room 6079, Rockville, MD 20852, UNITED STATES. Description The National Cancer Institute (NCI), Center for Cancer Research (CCR) plans to procure on a sole source basis with Advanced Bioscience Laboratories, Inc (ABL) of 9800 Medical Center Drive, Suite D Rockville, MD 20850 to provide stability testing of SS1P Immunotoxin drug product. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System Code is 621511 and the business size standard is $13.5 Million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. It has been determined that there is no opportunity to acquire Green Products or Services under this contract. The period of performance shall be twelve (12) months from date of award. Stability testing of Investigational New Drug Products being studied in human clinical trials is a requirement of the US Code of Federal Regulations (CFR) at 21 CFR 312.23 (a) (7) (b) and the good manufacturing practices regulations at 21 CFR 211.166. In addition to understanding the stability of the drug product, an understanding of the purity of the drug product is necessary to assure its ongoing safety as it ages. Appearance of degradation products is a concern for investigational drug products. Currently the SS1P immunotoxin is under study for stability at long term storage at -70 degrees centigrade using a reference standard SS1P immunotoxin lot as a comparator. This study will assist the government in determining the safe dating period for the drug product in ongoing clinical trials. LMB requires qualified, documented stability assays in conformance with the Food and Drug Administration's (FDA) guidelines for submission of Chemistry Manufacturing and Controls (CMC) as part of the Investigational New Drug (IND) application. Advanced BioScience Laboratories (ABL) currently performs stability testing for clinical lots of SS1P immuntoxin drug product stored at -70 to -80 degrees centigrade. These assays were developed in coordination with the NCI and are described in the Investigational New Drug (IND) application filed with the FDA. The Center for Therapy Evaluation Program (CTEP) in charge of the SS1P requires that NCI LMB not change vendors for the stability program as it may introduce problems with consistency in the assay and their subsequent analysis. For consistency of results and to avoid modifying the IND application and having to reproduce and validate the assays required in the stability program, ABL is the sole known source for this requirement. This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, they may submit a statement of capabilities. 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. An original and one copy of the capability statement must be received in the NCI Office of Acquisitions on or before 11:00 AM EST on June 22, 2012. No electronic capability statements will be accepted (i.e. email or fax); an original and one copy must be sent to the NCI Office of Acquisitions to the address stated above. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Miguel Diaz, Contract Specialist at miguel.diaz@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) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference solicitation number NCI-120081-MD on all correspondences.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/NCI-120081-MD/listing.html)
- Record
- SN02767368-W 20120608/120606235240-7b6a30c09c0a8f388a06709ae65e7750 (fbodaily.com)
- Source
-
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