SOLICITATION NOTICE
65 -- Production and Purification of Monoclonal Antibodies and Purification of Polyclonal Antibodies
- Notice Date
- 1/21/2004
- Notice Type
- Solicitation Notice
- 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
- 2/20/2004
- Archive Date
- 4/20/2004
- 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
- This notice is a request for a Technical Proposal as Step one of a Two Step Proposal. The anticipated contract award is a small business set aside (NAICS 325413, size standard 500 employees),Firm Fixed Price/IDIQ type contract for the commercial pro duction and purification of Monoclonal antibodies and the purification of Polyclonal antibodies supplied from a government laboratory. These antibodies are used in the testing, development, production, fielding and operational support of Biological Warfar e Defense detection and identification systems managed by the Joint Program Executive Office for Chemical and Biological Defense. The period of performance for the anticipated contract is for one Base year and four 12-month option periods. Delivery Order s for the combined proposed period of performance will be issued for the maximum of two kilograms of purified monoclonal antibody using mouse ascities production techniques and the purification of fifty kilograms of polyclonal antibody. Minimum yearly requ irements: Year One - Minimum of 4 kg of polyclonal and a Minimum of 100 g of fully delivered monoclonal antibody; Year Two - Minimum of 5 kg of polyclonal and a Minimum of 50 g of fully delivered monoclonal antibody protein, Year Three - Minimum of 4 kg of polyclonal and a Minimum of 50 g of fully delivered monoclonal antibody, Year Four - Minimum of 1 kg of polyclonal antibody and a Minimum of 50 g of fully delivered monoclonal antibody protein, Year Five - Minimum of 1 kg of polyclonal antibody and a Mini mum of 50 g of fully delivered monoclonal antibody protein. Government-designated laboratories shall conduct independent evaluations of antibodies manufactured by the Contractor prior to formal acceptance of product. Limited technical data packages on mo use monoclonal cell lines will be provided upon contract award. These will show media used to culture the cell line, isotype of cell line, originating laboratory, and buffer used to store purified antibody. The Government intends to use a two-step Invitat ion for Bid (IFB) process for this requirement and is outlined below. Interested Bidders are strongly encouraged to review the FAR Part 14 and DFARS Part 214 to understand a Two-Step Sealed Bid Process. Step-one (Technical Proposal) will not include pri ces or pricing information. Offerors should submit proposals that are acceptable without additional explanation or information. The Government may make a final determination regarding a proposal??????s acceptability solely on the basis of the proposal as submitted. The Government may proceed with the second step of the IFB process without requesting further information, but reserves the right to request additional information, and may discuss proposals with the offerors if it considers proposals are reas onably susceptible of being made acceptable. All offerors will by notified of any unacceptable proposal promptly upon completion of evaluation. Only those offerors that submit an acceptable Technical Proposal will be invited to proceed to step-two. For Step-Two, only bids based upon technical proposals determined to be acceptable, either initially or as a result of discussion will be considered for award; and each bid in step two must be based on the bidder??????s own technical proposals. POC: USASMDC, ATTN: SMDC-CM-CB/S. O??????Connell, 64 Thomas Johnson Drive, Frederick, MD 21702, or by fax to (301)619-5069 or electronically to Sandra.oconnell@det.amedd.army.mil. Bidders are to submit one (1) hard copy and one (1) electronic version of their technical proposal to USASMDC, ATTN: SMDC-CM-CB/S. O??????Connell, 64 Thomas Johnson Drive, Frederick, MD 21702 by 4:00 (eastern standard time) on 20 Feb 04. STEP-ONE TECHNICAL PROPOSAL REQUIREMENTS: Bidders are to submit one (1) hard copy and one (1) electronic version of their technical proposal with other required documentation as noted below, to USASMDC, ATTN: SMDC-CM-CB/S. O??????Connell, 64 Thomas Joh nson Drive, Frederick, MD 21702 by 4:00 (eastern standard time) on 20 Feb 04. In the event of disparities between the two submissions, the hard copy shall be used for evaluation of the technical proposal. The Technical Proposal response must include a re sponse for the following three parts as outlined below: 1. Technical Approach documentation must demonstrate and provide evidence of your technical capability to perform the requirements as listed in paragraphs a. through i. below. The quality of this documentation will be evaluated based upon the following factors: A) Methodology and allocation of resources that provides evidence of your ability to produce and purify monoclonal antibodies and purify polyclonal antibodies; B) Technical experience and expertise with animal handling and animal breeding prog rams; C) Quality control processes, methods and programs for maintaining a steady and consistent supply of monoclonal and polyclonal antibodies. Contract Requirements Information: a. The Contractor shall produce and purify a minimum of five (5) grams of monoclonal antibody for each mouse monoclonal cell line initially provided by the Government to the Contractor (10 to 20 cell lines). Production of monoclonal antibodies shall be p erformed using the mouse ascites method and not within hollow fiber culture or in vitro cell culture. The Government shall provide initial frozen aliquots of monoclonal cell lines to the Contractor. Requirement includes mouse monoclonal as well as goat an d rabbit polyclonal preparations. b. Contractor shall be responsible for maintaining back up stocks and expanding cell lines as necessary to ensure the production of ascities fluid at continual testing to ensure that antibody of the appropriate subtype continues to be secreted. c. Purification of goat polyclonal antibody in variable amounts per year as detailed in paragraph one for up to twenty (20) different biological targets. Sera from hyper-immunized animals will be shipped by the government prior to issuance of a delivery order directly to the Contractor sealed in plastic Nalgene polypropylene bottles that are packed in wet ice. Sera will be predominantly goat sera but the Government expects at least one agent to utilize rabbit sera. Sera will be segregated by animal and will have been pre-screened by a Government lab and selected for purification based on titration by direct ELISA. d. Contractor will be required to deliver antibody in a purified liquid state at protein concentrations in excess of 5 mg/ml but preferably with protein concentrations between 5 and 7 mg/ml. It shall have no visible precipitate or color. Antibody protei n solutions shall be packed in 50 cc polypropylene tubes sealed with non-leaking caps and wrapped securely in parafilm. The tubes shall be held firmly in foam racks or alternate shipping racks and shipped with ice packs to locations in Maryland. Tubes sh all be marked clearly with the lot number, protein concentration, date of manufacture, and cell line name in a coded format. e. Contractor shall be required to provide detailed reports/documentation of the production/purification of products (Contractor??????s Format). This shall at a minimum include the following: 1. Validation/Production Protocols. 2. Inventory of Products/services provided, to include shipping and receiving information. 2. Past Performance Information: Past Performance Information of at least three customers which provides evidence that supports your claim of credible, relevant experience of providing the following products/services: ( Data Sheet attached.) (a) Monoclonal ascities production and purification services. (b) Polyclonal purification services. (c) Production of raw material for diagnostics production for either the commercial sector or for the government. 3. Management Approach and Production Capacity: Provide documentation pertaining to your company??????s capabilit ies to perform under a Government contract for the above Contract Requirements, without acquiring additional facilities or major equipment. Include at a minimum the following: (a) Identification of key technical personnel that will be involved in this effort. Include resumes and any other relevant data that demonstrates your companies?????? capability to provide the required technical expertise for this effort. (b) Description of manufacturing facilities and infrastructure to perform and deliver on schedule and to accelerate deliveries if necessary. (c) Description of the company??????s animal housing sites, air handling system within animal housing sites, animal breeding programs, purification facilities, refrigerated storage capabilities, power backup systems, storage locations, physical accountabil ity records and security systems. (d) Description of quality programs and ISO (ISO 9001) or other certifications. (e) Description of company??????s shipping and handling capabilities. (f) Identification of any proposed subcontractors or teaming arrangements, and identification of effort to be accomplished by these subcontractors. Subcontractors must meet the same qualifications as for Prime Contractor as noted in paragraph (2.) (g) Provide any other documentation that will demonstrate your unique capabilities and capacity to perform under the proposed contract award. EVALUATION FACTORS Technical proposals will be evaluated on the following Factors (in order of importance): 1. Past Performance - Proposal must demonstrate the history of providing similar services/supplies that meet users needs, including cost and schedule. 2. Technical Capability - Proposal must demonstrate an understanding of the requirement and the ability to perform in a quality controlled manner. 3. Management and Production Capacity - Proposal must demonstrate the capacity to provide the required supplies or services without benefit of increased facilities or additional major equipment, and to respond to varying quantities ordered RATING SCALES: PAST PERFORMANCE: COLOR RATING DEFINITION GREEN ACCEPTABLE Past Performance information demonstrates that the Offeror has provided similar services/supplies to other users which are outstanding in essentially all respects; no deficiencies have been shown to have occurred in past efforts of a simil ar nature. YELLOW REASONABLY SUSCEPTIBLE OF BEING MADE ACCEPTABLE Past Performance information demonstrates that the Offeror has provided similar services/supplies to other users which have not always met or exceeded the needs of other users, RED UNACCEPTABLE Past Performance information demonstrates that the Offeror has not provided similar services/supplies to other users or has provided similar services/supplies but has not demonstrated the ability to meet or exceed the needs of other users, including cost and schedule. TECHNICAL CAPABILITY: COLOR RATING DEFINITION GREEN ACCEPTABLE Proposal demonstrates good or excellent understanding of requirements and approach meets or exceeds the performance or capability standards. It has strengths in quality assurance and animal handling/breeding areas that will significantly benefit the government. Proposal contains no deficiencies, and no significant weaknesses. YELLOW REASONABLY SUSCEPTIBLE OF BEING MADE ACCEPTABLE Proposal demonstrates shallow understanding of requirements and approach that only marginally meets the performance or capability standards. It has few or no strengths that will significantly benefit the government. Proposal contains deficiencies or significant weaknesses that may be corrected. Proposal is unacceptable but may be capable of being made acceptable. RED UNACCEPTABLE Fails to meet performance or capability standards. Proposal contains numerous deficiencies, significant weakness, and unlikely to contain any strengths. Can only be made acceptable with complete revisions to the proposal. MANAGEMENT APPROACH AND PRODUCTION CAPACITY: COLOR RATING DEFINITION GREEN ACCEPTABLE Proposal demonstrates good or excellent facilities/infrastructure to produce supplies/services to meet or exceed users needs. Has strengths that will significantly benefit the government. Proposal contains no deficiencies, and no signifi cant weaknesses. YELLOW REASONABLY SUSCEPTIBLE OF BEING MADE ACCEPTABLE Proposal demonstrates facilities/infrastructure that only marginally meets the production capacity required. Has few or no strengths that will significantly benefit the government. Proposal contains deficiencies or significant weaknesses that may be corrected. Proposal is unacceptable but may be capable of being made acceptable. RED UNACCEPTABLE Proposal does not demonstrate the facilities/infrastructure that meets the production capacity required. Has few or no strengths that will significantly benefit the government. Proposal contains numerous deficiencies, significant weaknes s, and does not contain any strengths. Can only be made acceptable with major infrastructure or major equipment acquisition. PAST PERFORMANCE DATA SHEET (Complete Contract Information for each contract/customer) 1. Contract Information: (To be filled out by Offeror/Bidder) Contract Number: Date Completed: Contract Type (circle): Fixed Price Cost Reimbursement Other: (Specify) Item Description: Contract Quantity/Length of Service: Customer Name: Customer POC: (Person who can verify data) Address: Telephone Number: Fax Number: Email Address: 2. Contract Information: (To be filled out by Offeror/Bidder) Contract Number: Date Completed: Contract Type (circle): Fixed Price Cost Reimbursement Other: (Specify) Item Description: Contract Quantity/Length of Service: Customer Name: Customer POC: (Person who can verify data) Address: Telephone Number: Fax Number: Email Address: 3. Contract Information: (To be filled out by Offeror/Bidder) Contract Number: Date Completed: Contract Type (Circle): Fixed Price Cost Reimbursement Other: (Specify) Item Description: Contract Quantity/Length of Service: Customer Name: Customer POC: (Person who can verify data) Address: Telephone Number: Fax Number: Email Address: Note: Sample Questions that will be asked of each POC: 1. Was consideration or a monetary withhold for non-conforming supplies /services or late deliveries assessed against this contract? 2. Was/is any part of this contract terminated for default and/or in litigation? 3. Where there any quality control issues for supplies and or services obtained? (Positive or negative) 4. Where all items delivered within the original contract schedule? 5. Was the original contract estimate cost(s) met?
- 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
- SN00507451-W 20040123/040121212356 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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