G
List Biological Laboratories, Inc. is the only known vendor/service provider that can manufacture high quality, lipopolysaccharide (LPS) isolated from E. coli O113:H10: K-. and deliver a minimum of 2,000 vials of each concentration: 1 μg per vial and 10 μg per vial. The product is for Phase 1 and 2 clinical trials and manufacturing is to be compliant with current Good Manufacturing Practices (cGMP).
ADDITIONAL DELIVERABLES:
I. Extraction and purification of high quality LPS from E. coli strain O113:H10: K-. E.coli 0113 O113:H10: K- strain will be provided by the vendor. Extraction and purification techniques will be compliant with cGMP and the resulting bulk drug substance will be freeze-dried for future manufacturing purpose.
II. The bulk drug substance LPS will be formulated in 1% lactose, 0.1% PEG 6000, aseptically filled into 2 mL glass vials, and lyophilized.
III. Each concentration of the final vialed product will be considered an independent lot and be tested and released as such. The bulk drug substance LPS and each lot of final vialed product will be tested as outlined in Attachment: "FINAL LOT TESTING CRITERIA".
IV. The vendor will prepare a Drug Master File for submission to the FDA. Letters of cross-reference to the DMF will be provided to parties identified by the NIH for inclusion in the appropriate Investigational New Drug Application (INDs).
V. 5 years of stability testing for both lots of the Final Vialed Product (1 ug/vial and 10 ug/vial) will be provided. Stability testing should include, at a minimum, endotoxin activity (potency), sterility, and moisture content.
Delivery shall be "FOB Destination" to:
9000 Rockville Pike, 10 Center Dr., Building 10, Pharmacy Development Service no later than 90 days ARO with five additional years for stability testing.
Inspection and acceptance shall be performed by the Government Personnel at the Government Facilities.
The acquisition is being conducted using policies unique to the acquisition of commercial items prescribed in FAR Part 12, in conjunction with the policies and procedures for the competition requirements of FAR Subpart 6.302-1. Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. No solicitation is available. Information received will be evaluated for the purpose of determining whether to conduct a competitive procurement. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government.
Each response should include the following Business Information:
a. DUNS.
b. Company Name, address, POC, Phone and Email address
c. Current GSA Schedules or NAICS codes appropriate to this Award.
d. Type of Company (i.e., small business, 8(a), woman owned, hubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1
e. Capability Statement
Comments to this announcement, may be submitted to the Clinical Center , Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contract Specialist, [email protected] by the due date and time marked in this notice.