MODIFICATION
68 -- Clinical Lot of K562 GM-CSF cells
- Notice Date
- 5/19/2009
- Notice Type
- Modification/Amendment
- NAICS
- 541380
— Testing 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
- RFQ-NCI-90095-NG
- Archive Date
- 6/4/2009
- Point of Contact
- Malinda L Holdcraft, Phone: (301) 402-4509, Caren N Rasmussen, Phone: (301) 402-4509
- E-Mail Address
-
holdcram@exchange.nih.gov, cr214i@nih.gov
(holdcram@exchange.nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This Combined Synopsis/Solicitation has been amended to extend the due date to May 20, 2009 at 11am. This Combined Synopsis/Solicitation has been amended to DELETE Recovery and Reinvestment Act Action from Yes to NO. The National Cancer Institute (NCI) plans to procure a clinical lot of K562 GM-CSF cells, including irradiation of the intermediate bulk and cGMP fill and finish, to be used for clinical research. This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. RFQ-NCI-90095-NG includes all applicable provisions and clauses in effect through FAR FAC 2005-31 (April 2009) simplified procedures for commercial items. The North American Industry Classification System Code is 541380 and the business size standard is $12M. Small businesses are encouraged to apply. Only one award will be made as a result of this solicitation. Statement of Work Contractor Tasks: The Contractor shall produce one clinical lot of K562 GM-CSF cells, including irradiation of the intermediate bulk and cGMP fill and finish. The clinical lot shall be sufficient to facilitate the release of approximately two hundred twenty (220) vials at a concentration of 5 x 1 E 7cells/ml/vial. This irradiation is absolutely necessary for patient safety, as mandated by Center for Biologics Evaluation and Research of the Food and Drug Administration, FDA, to ensure that the cells are viable, yet fully inhibited in their growth. Release testing and final disposition of the clinical lot shall be the responsibility of the Contractor. Release tests to be performed at the Contractor facility include: a. Post-thaw viability b. Expression of relevant cell surface markers (CD71, Glycophorin A) c. GM-CSF levels by ELISA. d. Residual Hygromycin Levels. Release testing to be performed: a. Sterility (21CFR 610.12) b. Mycoplasma (CBER Points to Consider) c. LAL endotoxin Deliverables: A. The clinical lot of K562 GM-CSF irradiated cells, containing approximately 220 vials at a concentration of 5 x 1 E 7 cells/ml/vial. B. The Contractor shall provide a Product Specification and a Certificate of Analysis (COA) for the clinical lot of K562 GM-CSF (irradiated) cells. This information shall be provided to the NCI project officer within 8 weeks of completion of production. C. The Contractor shall provide a copy of the Material Specifications for the growth media and for the components of the directly-injectable cryopreservant. PHASES: 1st phase- Order reagents - 1-2 weeks, from receipt of order. 2nd phase - Cell production and vialing - 13-16 days (must be completed before 06/30/09). 3rd phase - In house testing for GM-CSF secretion and viability post-thaw – (10 days from completion of cell expansion and vialing). 4th phase - Testing for sterility, endotoxin, mycoplasma (To be completed within 8 weeks of production/vialing). 5th phase - Report generation for manufacturing, and regulatory documentation for manufacturing, (including letter of cross-reference to Hy Levitsky's IND) – (within 3 weeks of completion of phase 4). Minimum Contractor Qualifications: Contractor shall have >5 years experience in producing human cancer cell master banks for clinical trials, including documented expertise regarding expansion of K562-GMCSF cells in serum free media. Contractor shall have facilities that are FDA approved for cell vaccine production. Contractor shall demonstrate proof of access to a clinical lot of K562 hGM-CSF cells, and prior experience regarding expansion of these cells under GMP conditions. Period of Performance shall be from May 28, 2009 through September 15, 2009. CLIN-001: Contract Line Item Number Description: CPGT Quality Assurance of Batch Production Quantity: One charge CLIN-002 Description: Quality Assurance (QA) release of the production Suite Quantity: One charge CLIN-003 Description: Production of 220 vials under cGMP Quantity: One charge CLIN-004 Description: Issuance of Certificate of Analysis Quantity: One charge BASIS FOR AWARD: Award will be made, subject to available funding and quoter responsibility, to that acceptable quote, the price or cost of which is not necessarily the lowest, but which is sufficiently more advantageous to the Government than the lowest offer so as to justify the payment of additional amounts, based on the evaluation criteria described in this section. This section shall describe technical information that the offeror’s provides. The technical proposal should clearly and fully demonstrate the offeror’s capabilities, knowledge, and experience regarding the technical requirements described below. Failure to respond explicitly to each of the categories and subcategories listed below may result in the offeror’s quotations being deemed technically unacceptable. The Evaluation Process: The Government will award a contract resulting from this quotation to the responsible contractor whose quote conforming to the quotation will be the most advantageous to the Government, price and other factors considered. The following evaluation factors shall be used to evaluate the prospective contractors and are listed in order of importance. 1. Technical Capability (40 points) 2. Past Performance (30 points) 3. Facilities (30 points) 4. Price Past Performance Information: Quoters shall submit the following information as part of their response. • A list of the last three (3) contracts completed during the past five years and all contracts currently in process that is similar in nature to the solicitation. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Quoters/offerors that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. Include the following information for each contract or subcontract: 1. Name of Contracting Organization 2. Contract Number (for subcontracts, provide the prime contract number and the subcontract number) 3. Contract Type 4. Total Contract Value 5. Description of Requirement 6. Contracting Officer's Name and Telephone Number 7. Program Manager's Name and Telephone Number 8. Standard Industrial Code The quoter/offeror may provide information on problems encountered on the identified contracts and the quoter’s/offeror's corrective actions. Each quoter/offeror will be evaluated on its performance under existing and prior contracts for similar products or services. The Government is not required to contact all references provided by the quoter/offeror. Also, references other than those identified by the quoter/offeror may be contacted by the Government to obtain additional information that will be used in the evaluation of the quoter/offeror's Past Performance. FORMAT AND INFORMATION FOR SUBMITTING A QUOTATION: Please submit ONE (1) original plus one (1) copy of entire quotation. Please mark original as “ORIGINAL” and copy as “COPY.” Please submit responses in TWO SEPARATELY BOUND VOLUMES Faxed or electronic mail submissions of quotations, will not be accepted Quotation packages shall be mailed or delivered to: National Cancer Institute – Office of Acquisition; Attn: Malinda Holdcraft, Contract Specialist; 6120 Executive Boulevard Room 6072; Rockville, Maryland 20852-7194 VOLUME 1: CONTRACT AND PRICING DOCUMENTS • Signed SF1449 (page 1, blocks 12, 17a, 21, 23, 24, 30a, 30b and 30c and other pricing information). • Signed amendments (if applicable). • Representations and Certifications (Contractors must have valid certification/registration in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) in order to receive an award). Please provide a copy of each, the CCR and ORCA registrations. The Evaluation Criteria shall be applied in assessing quotations. The criteria are listed in descending order of importance. VOLUME 2: TECHNICAL FACTORS: 1 Technical Capability (40 Points): The technical response should clearly and fully demonstrate the quoter’s full understanding of the capabilities, knowledge and experience, and personnel requirements, as stated in the statement of work. Failure to respond explicitly to each of the categories may result in the quoter’s offer/quotation being deemed technically unacceptable. A. Experience and training of personnel in performing GLP- and FDA-compliant biosafety testing as described in the SOW. B. Experience and training of personnel in performing biosafety testing. i.Documentation of personnel training programs and certification testing. C. Documentation of experience and training of personnel responsible for Quality Assurance and Quality Control oversight including assay performance, data analysis and report generation. 2 Past Performance (30 Points) The Government will evaluate the offeror's past performance based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. The Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror's performance. The lack of a performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror. The past performance subfactors are listed below in order of relative importance. These subfactors will be used to evaluate the quality of past performance. Past Performance Subfactors: • Record of conforming to specifications and to standards of good workmanship • Adherence to contract schedules, including the administrative aspects of performance • Reputation for reasonable and cooperative behavior and commitment to customer satisfaction • Business-like concern for the interest of the customer Demonstration of the ability to perform biosafety testing as described in the SOW for master cell bank in accordance with current FDA regulatory guidelines. i. Documentation for number of assays performed by offeror and any subcontractor. a.Summation of product/assay failures for last 12 months. b.Demonstration assays can be completed within a 3 month time frame including delivery of final reports. ii. Demonstration of GMP/GLP compliance. iii. Summation of most recent FDA audit and plans for resolution of any findings. 3. Facilities: (30 points) A. Documentation that physical facilities for biosafety testing described in the SOW are GLP- and FDA-compliant including facilities diagrams, process flows and summary of most recent FDA audit. B. Documentation for test article receipt, test article tracking and assay tracking. C. Documentation of prior expansion of K-562 GMCSF cells for human vaccine production. 4. Price (Price will be evaluated separately but not scored). PROVISIONS AND CLAUSES: The following FAR provisions and clauses apply to this acquisition: FAR clause 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (June 2008); FAR clause 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS- (February 2009) WITH DUNS NUMBER ADDENDUM {52.204-6 (April 2008}; FAR Clause 52.212-4 CONTRACT TERMS AND CONDITIONS – COMMERCIAL ITEMS (March 2009); FAR Clause 52.212-5: CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (April 2009). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition: 52.222-3 Convict Labor 52.222-19 Child Labor-Cooperation with Authorities and Remedies 52.222-21 Prohibition of Segregated Facilities 52.222-26 Equal Opportunity 52.222-35 Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans 52.222-36 Affirmative Action for Workers with Disabilities 52.222-37 Employment Reports of Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans 52.222-39 Notification of Employee Rights Concerning Payment of Union Dues or Fees (DEC 2004) (E.O. 13201). 52.223-15 Energy Efficiency in Energy-Consuming Products 52.225-5 Trade Agreements (Nov 2007) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). 52.232-33 Payment by Electronic Funds Transfer–Central Contractor Registration 52.239-1 Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a) Full text copies of the representations and certifications for other cited provisions and clauses may be obtained on line at the NCI OA Internet website at http://amb.nci.nih.gov or from Malinda Holdcraft, Contract Specialist at holdcram@exchange.nih.gov. OFFERORS: Offers must be submitted on an SF-1449, signed by an authorized representative and shall provide a copy of the valid certification registrations: (a) offeror’s Central Contractor Registration (CCR) and (b) Online Representations and Certifications Applications (ORCA). ALL QUESTIONS REGARDING THIS SOLICITATION SHALL BE ADDRESSED TO MALINDA HOLDCRAFT, CONTRACT SPECIALIST, VIA ELECTRONIC MAIL AT HOLDCRAM@EXCHANGE.NIH.GOV Faxed or electronic mail quotations will NOT be accepted. Quotations shall be mailed to the following: National Cancer Institute – Office of Acquisition; Attn: Malinda Holdcraft, Contract Specialist; 6120 Executive Boulevard Room 6072; Rockville, Maryland 20852-7194. Quotations must be received in the NCI-OA contracting office by 11:00 AM on May 19, 2009. Please refer to solicitation number RFQ-NCI-90095-NG on all correspondence. PLEASE NOTE: In order to receive an award, contractor must be registered in and have valid certifications in the Central Contractor Registration (CCR) (http://www.ccr.gov) and the Online Representations and Certifications Application (ORCA) (http://orca.bpn.gov) AND shall meet all the specifications stated above.
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