Loren Data's SAM Daily™

FBO DAILY ISSUE OF OCTOBER 02, 2004 FBO #1041
SOLICITATION NOTICE

A -- Process Development, Assay Development, and Small Scale Manufacturing of Butyrylcholinesterase (BChE) Derived from Human Source Plasma for Use in Preclinical and Clinical Trials (Short Name: BioScavenger)

Notice Date

9/30/2004
 

Notice Type

Solicitation Notice
 

NAICS

541710 — Research and Development in the Physical, Engineering, and Life Sciences
 

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-05-R-0000
 

Response Due

10/31/2004
 

Archive Date

12/30/2004
 

Small Business Set-Aside

N/A
 

Description

The Department of Defense (DoD) through the Chemical, Biological, and Medical Systems Joint Project Management Office (CBMS) and the Medical Identification and Treatment (MITS) System Joint Product Management Office has a requirement for process deve lopment, assay development and small scale manufacturing of butyrylcholinesterase (BChE) derived from human source plasma suitable for use in preclinical and clinical studies. There is also a requirement for an acute toxicology study of BChE in rodents. This product is being developed in response to a requirement to provide protection from exposure to the toxic effects of chemical warfare agents. The process development efforts will be directed at ensuring the availability of required starting materials and the improvement of manufacturing processes to achieve high yields. A minimum of 40-50 grams of BChE manufactured in accordance with Good Manufacturing Practices (cGMP) regulations and guidelines is required for the proposed effort. The process and pr ocedures must be amenable to large scale manufacturing. The acquisition strategy for this effort requires expeditious contractor performance so that an Investigational New Drug (IND) product will be available to transfer to the Department of Health and Human Services not later than August 2007. Participation i n this competition requires all interested offerors to demonstrate its ability to provide current Good Laboratory Practice (cGLP) and current Good Manufacturing Practice (cGMP) compliance related to the development of a plasma product for use in preclinica l and clinical studies. This includes providing evidence of: Capability and resources for assay development and qualification, beginning on or about February 2005 (on award of contract). Analytical assays for cGMP release, manufacturing in-process controls, and acute toxicology studies. Capability and resources to develop a scalable process for manufacture of high purity cGMP human butyrylcholinesterase, beginning on or about February 2005 (on award of contract). Capability and resources to develop formulations of the cGMP product suitable for use in humans. Capability and resources to transition to cGMP manufacturing no later than November 1, 2005. Capability and resources to produce 40-50 grams of cGMP product within approximately 12-months of contract award. Reliable, steady sourcing of plasma (or Cohn fraction) suitable for manufacture into a cGMP product for use in humans and which will sustain production of 40-50 grams cGMP product. Capability to manufacture and release the cGMP product for IND use. Capability and resources to conduct a GLP-compliant acute toxicology study and other preclinical studies to support filing of an IND (using product). Past performance in production of plasma products for use in humans. In responding to this presolicitation announcement, offerors shall affirm, in either a letter or electronic communication to the contracting officer, that it can meet all of the qualification requirements. Upon receipt of an expression of interest to part icipate in a competition for this requirement, a MITS regulatory compliance team shall conduct a facility compliance review to verify the accuracy of the offerors affirmations. The regulatory compliance team will provide advance notice of its visit to th e offerors facilities. The teams findings and recommendations to the MITS product manager shall render an offeror qualified or not qualified to execute a contract for BChE within the required time. The offeror is solely responsible for furnishing the re gulatory compliance team the necessary information to demonstrate meeting the qualifications. Offerors not meeting these requirements shall not receive a request for proposal. Subcontractors may be used. If an offerors approach includes subcontract performance, the offeror shall provide the same qualification information for the subcontractor(s ). The government regulatory compliance team shall similarly conduct a site visit of the subcontractor. If the proposed subcontractor fails to meet the appropriately applicable requirements for the work to be under subcontract, the offeror shall be exclu ded from participation. There is zero tolerance for delay in performing a contract for BChE. Once the qualified competitors are identified, a request for proposal shall be released for formal proposals and consideration for award based on schedule and cost. In addition to the qualification requirements provided earlier, all interested offerors shall include in their written response to this synopsis the companys CAGE code, Duns number, and business size for a NAICS project coded 541710, 500 employees. All r esponsible sources may submit a request to participate in this acquisition, which shall be considered by the agency. This acquisition is open to participation by foreign firms at both the prime contract and subcontract level, subject to FAR/DFARS Part 25 limitations. This announcement shall be open for a period of thirty (30) calendar days after publication in FEDBIZ OPS. Offerors that fail to identify themselves within the 30-day window shall not be permitted to participate in this competitive solicitati on. The following numbered notes are applicable to this acquisition: 12, 15, 25, and 26. Point of Contact is Lynn Selfridge. Email address is lynn.selfridge@us.army.mil, telephone number is 301 619-2707.
 

Place of Performance

Address: US Army Space and Missile Defense Command, Chemical and Biological Operations Branch 64 Thomas Johnson Drive Frederick MD

Zip Code: 21702-5014

Country: US
 

Record

SN00687209-W 20041002/041001111633 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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