MODIFICATION
65 -- Production and Purification of Monoclonal Antibodies and Purification of Polyclonal Antibodies
- Notice Date
- 2/11/2004
- Notice Type
- Modification
- Contracting Office
- US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
- ZIP Code
- 35807-3801
- Solicitation Number
- W9113M-04-B-0001
- Response Due
- 2/27/2004
- Archive Date
- 4/27/2004
- Point of Contact
- Sandra OConnell, 301-619-2895
- E-Mail Address
-
Email your questions to US Army Space and Missile Defense Command, Deputy Commander
(sandra.oconnell@det.amedd.army.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- The purpose of this modification/amendment, is to provide answers to questions received regarding the subject Request for Technical Proposals, Step one of Two Step Sealed Bid. As a result of this modification, the response due date is hereby extende d to 27 Feb 2004. 1. QUESTION: Will the polyclonal antibodies be antigen affinity purified or purified IgG? ANSWER : Affinity purification will be done by the Government not the contractor. These are just protein A purified antibodies. 2. QUESTION: Will the hybridoma cell lines provided come with any certificate with regard to health? For example, will they be certified mycoplasm free? ANSWER: No 3. QUESTION: How long after award of contract will the sera be shipped for purification and at what rate? ANSWER: Upon issuance of a Delivery Order. 4. a. QUESTION: How long after award of contract will the hybridoma cell lines be shipped for ascites production? ANSWER: Upon issuance of a Delivery Order. b. QUESTION: Will all cell lines be shipped at once? ANSWER: No, see above c. QUESTION: Will historical ascites yields (volume and monoclonal secretion) be provided for technical and financial proposal submission? Without this information, technical levels of effort and associated financial estimates may be grossly over or unde r estimated. ANSWER: No these will not be provided until contract award/issuance of Delivery Orders. 5. a. QUESTION: What will the acceptance criteria be for the delivered antibodies? The government is providing the sera, therefore all the contractor should prove is that the IgG was purified from the sera. ANSWER: Government-designated laboratories shall conduct independent evaluations of antibodies manufactured by the Contractor prior to formal acceptance of product utilizing an activity assay based on an ELISA and adjusted for antibody content versus gold standard antibody. b. QUESTION: What will the acceptance time period be by the government such that the contractor may invoice for payment? ANSWER: Commercial practices. 6. QUESTION: What monoclonal antibody isotypes are expected to be secreted by the government furnished hybridoma cells? Will any be IgG or IgM? IgG3? ANSWER: All will be IgG??????s with one possible IgA. ??????7. QUESTION: It is suggested that the contractor be supplied government antigen for in-house pre and post purification acceptance and validation. We feel that this is technically sound. It will give the government the most streamlined, cost effec tive products. In this case, will a CDC license be required to perform these tasks? ANSWER: No this is not within scope 8. QUESTION: The word ??????coded?????? is utilized in the announcement. It is suggested that eligible companies possess a current facility clearance to the secret level and that as a minimum the project manager possess a current personnel clearance leve l of secret. This would be a requirement since acceptance criteria would have to name the target antigen if data needs to be shared between the testing facility and contractor. ANSWER: No clearance is required. The reference to ??????coded?????? in the Request for Technical Proposal was in error and should read ??????uncoded??????. 9. QUESTION: Page 3 of the solicitation refers to a ??????data sheet attached?????? for describing past performance. There does not seem to be a link to access the data sheet. Please clarify. ANSWER: The Data Sheet is included in the last section of the Request for Technical Proposal. 10. QUESTION: The monoclonal antibodies are to be aliquoted in 50 cc tube. We feel this would not be practical for the polyclonal due to the volume. Are one liter containers sufficient for polyclonals? ANSWER: Yes. End of modification
- Place of Performance
- Address: US Army Space and Missile Defense Command, Deputy Commander ATTN SMDC-CM-AP, P.O. Box 1500 Huntsville AL
- Zip Code: 35807-3801
- Country: US
- Zip Code: 35807-3801
- Record
- SN00520647-W 20040213/040211212639 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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