SOURCES SOUGHT
65 -- : cGMP manufacturing of a sterile DMSO solution of TWS119
- Notice Date
- 8/11/2017
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02RC72648-36(A)
- Archive Date
- 8/31/2017
- Point of Contact
- David H. Romley, Phone: 2402767822
- E-Mail Address
-
david.romley@nih.gov
(david.romley@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SOURCES SOUGHT NOTICE: cGMP manufacturing of a sterile DMSO solution of TWS119 Notice Number: N02RC72648-36(A) Issued By: National Cancer Institute (NCI), Office of Acquisitions (OA) http://www.nci.nih.gov or http://rcb.cancer.gov/rcb-internet/ Key Dates: Capability Statement Due Date: August 16, 2017 by 12:00PM EST This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The purpose of this Sources Sought Notice is to identify qualified Small Business concerns including 8(a), HUBZone or Service-Disabled Veteran-owned businesses that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned North American Industry Classification System (NAICS) code 541711 with a size standard of 1,000 employees. As a result of this Sources Sought Notice, the NCI may issue a Request for Quotation (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Sources Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. The National Cancer Institute (NCI), Experimental Transplantation and Immunology Branch (ETIB) needs to acquire GMP sterile DMSO solution of TWS119 for the generation of anti-CD19 CAR-modified T memory stem cells to be employed in human clinical trials to be conducted at the ETIB. The following services are required for this requirement: • Analytical method transfer and qualification • Preparation of Master Batch Record and final product, and QA approval • Raw material testing and release. Preparation of Raw Material and Component Specifications • Manufacture of cGMP Batch (1L scale - 200 of 5 mL vials) of sterile product. Cleaning verification and Waste disposal • Packaging and labeling • Drug Product release testing and QA Release; 7) Sterility <USP 71> and Endotoxin <USP 85> • Manufacturing batch record documentation including certificates of analysis (CoAs) to RO • Shipment of CTM to the client or toxicology study site. All these services need to meet the requirements of US-FDA for the use of small molecules in human clinical trials. How to Submit a Response: 1. Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed 10 single sided pages including all attachments, resumes, charts, etc. (single spaced, 12-point font minimum) that clearly details the ability to perform the requirements of the notice described above. All proprietary information should be marked as such. Responses should include a minimum of a one page resume of the individuals meeting the requirements, and up to two pages demonstrating experience over the past two years meeting the requirements of this notice. Statements should also include an indication of current small business status; this indication should be clearly marked on the first page of your capability statement (preferable placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. Organizations shall demonstrate 1.) Technical Approach 2.) Personnel Requirements and Organizational Experience. 2. Due Date: Capability statements are due no later than August 16, 2017 by 12:00PM EST 3. Delivery Point: All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein. All questions must be in writing and emailed to David.Romley@nih.gov. A determination by the Government not to compete this 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 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 number N02RC72648-36(A) on all correspondence. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a RFQ may be published in Fed Biz Opps. However, responses to this notice will not be considered adequate responses to a solicitation(s). Point of Contact: Inquiries concerning this Notice may be direct to: David Romley at David.Romley@nih.gov. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02RC72648-36(A)/listing.html)
- Record
- SN04624423-W 20170813/170811231604-6fac747cc2a946900f7fafbd746af58c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |