SOURCES SOUGHT
A -- Sources Sought Notice for Contract Manufacturing Organizations
- Notice Date
- 10/17/2012
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of the Army, Army Contracting Command, ACC-APG - Natick (SPS), BLDG 1 KANSAS ST, Natick, Massachusetts, 01760-5011, United States
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-13-S-0002
- Archive Date
- 12/4/2012
- Point of Contact
- Richard W. Totten, Phone: 3016192446
- E-Mail Address
-
richard.totten1@us.army.mil
(richard.totten1@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts or quotations. The objective of this notice is to identify Contract Manufacturing Organizations (CMOs) capable of performing routine commercial scale manufacturing of a recombinant protein from a Pichia pastoris (P. pastoris) expression system to fulfill future operational requirements. The recombinant protein is manufactured at Biosafety Level 1 (BSL 1). Responding CMO must be able to demonstrate established capabilities in the following areas: (a) commercial production in a licensed facility; (b) recombinant protein production from P. pastoris expression system using a minimum of 500 L fermentation scale; (c) column chromatography purification using a minimum of 200L scale; (d) lot release and stability testing for identity, purity, quality and safety; (e) quality systems to support commercial production of licensed product. The contractor must demonstrate the ability to comply with the FDA's current Good Manufacturing Practice (GMP), US Code of Federal Regulations (21 CFR parts 210, 211, 600, 606, and 610) and International Conference on Harmonization (ICH) guidance documents. This is not a request for competitive proposals, however, interested parties should respond in writing with a synopsis of their capabilities and related past performance. Additionally, each response should include the following Business information: a. DUNS number b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative/business), including names, titles, addresses, telephone and fax numbers and email addresses. e. Do you have a Government-approved accounting system? f. Type of Company (i.e. small business, 8(a), woman owned, veteran owned, etc). Contact Information: Inquiries shall be transmitted either via email, fax, or paper copy to Linda S. Howell, Sr. Principal Subcontract Administrator, DVC, a CSC Co. at 64 Thomas Johnson Drive, Frederick MD 21702 or fax to : 301-607-5023, or via email to: LHowell3@csc.com. Please only contact the person above and not the Government agency office listed in this announcement. Disclaimer: Any work effort that may result from this sources sought notice will be conducted through DVC as the Prime Systems Contractor and not the Government. This notice does not obligate DVC to award a contract or otherwise pay for the information provided in response. Note that DVC will not entertain questions regarding this Market Research; however, general questions can be presented in your response. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/2bbeca57b98ca5a6825151bd599d115e)
- Place of Performance
- Address: DVC, a CSC Co., 64 Thomas Johnson Drive, Frederick, Maryland, 21702, United States
- Zip Code: 21702
- Record
- SN02915444-W 20121019/121017234505-2bbeca57b98ca5a6825151bd599d115e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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