SOURCES SOUGHT
A -- Scale-Up of Lyophilization Using Dimensionless Prediction
- Notice Date
- 8/28/2009
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-09-1062623-SS
- Point of Contact
- Karen R. Petty, Phone: 301-827-8774, Doreen Williams, Phone: 301-827-3366
- E-Mail Address
-
karen.petty@fda.hhs.gov, doreen.williams@fda.hhs.gov
(karen.petty@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential certified 8(a) and/or HUB Zone businesses. Project Title Scale-Up of Lyophilization Using Dimensionless Prediction Statement Statement of Objective (SOO) The object is to link process variables to the crystal morphology and stability characteristics of a model drug in a quantitative way with in a feasible design of experiment. This should enable full study of scale independent (dimensionless) prediction suitable for modeling of the Lyophilization process at both laboratory and manufacturing scale. Statement of Work (SOW) The contractor shall minimize the need for training by demonstrating previous work in the FDA regulated topic area. The contractor shall maximize the potential for consensus by demonstrating previous collaborations involving multiple universities involved in this topic area. The contractor shall maximize the ease of creating training materials by demonstrating previous efforts in training 50 to 100 people at a time. The contractor shall provide a report that evaluates the influence of natural variations in the manufacturing environment on the critical quality attributes of freeze dried products at a laboratory scale. This shall include reference to literature articles that are pivotal to understanding this process. The contractor shall develop a design of experiment (DOE) to quantify the frequency distribution of product temperatures and primary drying time due to vial heat transfer coefficient, edge vial heat transfer; fill volume and product heat resistance on a laboratory scale. This will include cake thickness variation and nucleation temperature control using modern technique. This DOE will include laboratory and manufacturing scale processes. The contractor shall focus this DOE on the evaluation of temperature variations during processing and the effects on the product’s critical quality attributes. This should measure variation within batches and between multiple batches of the model drug. These attributes will include variation in appearance, stability and crystal morphology. The contractor shall provide preliminary results on the laboratory scale to verify the feasibility of the study in anticipation of a full laboratory scale investigation. The contractor shall provide training materials and present this DOE to the FDA. Contractors shall satisfy the following requirements. Provide a detailed description of your company’s (including its teammates, if applicable) experience and demonstrated abilities to deliver each and every one (address each separately) of the following requirements: A fixed price contract is anticipated. This is a new requirement. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents’ capacity and capability to perform the specific work as required. Responses to this notice shall be limited to [15] pages, and must include: 1.Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2.Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3.Business size for NAICS _______ (size standard $ or number of employees) and status, if qualified as an 8 (a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4.DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5.Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6.If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm’s status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, shall also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted shall be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA, may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is for Government market research only, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. RESPONSES DUE: All capability statements must be received by email to: karen.petty@fda.hhs.gov, on or before September 2, 2009 no later than 4:30pm, EST. Telephone calls will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1062623-SS/listing.html)
- Record
- SN01932214-W 20090830/090829005053-c0f23e457b90da8f6ee5a8d83c1c9480 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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