General Information:

This Sources Sought Notice (SS) is for
information and planning purposes only and shall not be construed as a
solicitation or as an obligation on the part of SAIC-Frederick, Inc. (SAIC-F)
or the National Cancer Institute at Frederick
(NCI-F).  SAIC-F does not intend to award
a contract on the basis of responses to this Sources Sought Notice, nor
otherwise pay for the preparation of any information submitted. As a result of
this Sources Sought Notice, SAIC-F may issue a Request for Proposal (RFP) in
the future. THERE IS NO SOLICITATION SCHEDULED AT THIS TIME. However, should
such a requirement materialize, no basis for claims against SAIC-F shall arise
as a result of a response to this Sources Sought Notice or the SAIC-F's use of
such information as either part of our evaluation process or in developing
specifications for any subsequent requirement.  Any questions concerning this solicitation must be directed through the
SAIC-F Point Of Contact (SAIC-F POC).

RFI Number:  S09-099

Posted Date:     December
19, 2008

Intended Bidders Response Date:  December 30, 2008 by 4:00PM Eastern

Final day to submit questions:  January 12, 2009 by 12 Noon Eastern

Final Response Date:  January 30, 2009 by 3:00PM Eastern

Contracting office address:        SAIC-Frederick,
Inc.

                                                92 Thomas Johnson Drive, Suite 250

                                                Frederick, MD
21702-1201

Purpose
of RFI:

SAIC-F is to seeking to
identify a qualified contract research organization that
is able to economically produce a new batch of clinical grade bulk
endotoxin that is compliant with current Good Manufacturing Practices to
replace the > 30 year old bulk endotoxin currently in storage.  PLEASE NOTE:  An appropriate strain of E. coli would be required to be acquired by any
potential Subcontractor should a Request for Proposal (RFP) and subsequent
Subcontracting Agreement be offered to a selected offeror.

Project Goal:

The goal included in
this statement of work is to produce a new batch of clinical grade bulk
endotoxin that is compliant with current Good Manufacturing Practices to
replace the > 30 year old bulk endotoxin currently in storage. This project
will be broken down into a Development Section, including MCB production, and
purification process development. An engineering run of bulk endotoxin along
with a pilot lyophilization study. The final stage includes cGMP Production;
including GMP bulk endotoxin manufacture and GMP vialing and lyophilization
plus a manufacturing report.

Anticipated Milestones and Deliverables:

Milestone 1 – Activity A: Production and
characterization of a 200 vial Master Cell Bank.

The previous cGMP
endotoxin was produced from the Escherichia coli (Braude strain) group O
113:H10:K negative strain that was isolated and characterized at the
Bacteriology Division, Bureau of Laboratories, Center for Disease Control,
Atlanta, Georgia (Ewing WH, Hucks MC, and Taylor MW (1952) J Bacteriology 63: 319-325).  The BDP will contact Dr.
Epstein to determine if this bacterial strain is available from the NIH Clinical
Center, the FDA, or the
CDC.

The potential
Subcontractor will obtain the appropriate strain of E. coli and then
manufacture and characterize the 200 vial MCB according to current standards.
The potential Subcontractor will provide a list of tests to be performed.
SAIC-F may provide the potential Subcontractor a source of the required strain
if necessary.

Milestone 1 – Activity B: Purification
Development.

R&D grade E.
coli cultures will be produced using the previously recommended chemically
defined media and conditions.  These
cultures will be produced in the potential Subcontractor’s laboratories using
standard R&D procedures and it is expected that this process will require
minimal development work.

The resulting cell
pellets will be used for purification development following the previous
purification process used > 30 years ago.  The potential Subcontractor will provide a proposal for process
modification (if any) to meet the required scale, cGMP compliance, and product
quality. Such studies may include: 

1.      A 10 liter culture will be produced and subjected to
phenol extraction to produce a single unpurified bulk that can be used for
purification development studies.  

2.      Tests to replace a dialysis step with transmembrane
flow filtration (TFF).

3.      Determine whether the deoxyribonuclease digestion can
be replaced with Benzonase digestion.

4.      Testing chromatography as a replacement for the sodium
acetate/ethanol concentration step.

5.      Determine whether the final dialysis step can be
replaced with TFF.

Milestone 1 – Activity C: R&D Assay
Development.

The potential Subcontractor will
identify any method development necessary to perform the required release
testing for the bulk and final vialed product shown in Tables 1 and 2.

SPECIAL NOTE: SAIC-F, with the NCI,
will contact the US FDA for review of the proposed methods of analysis and
specifications prior to initiation of the cGMP phase of the program. The
results of that future discussion will be shared with the potential
Subcontractor.

Milestone 2: Engineering Run/Pilot
Lyophilization

The potential
Subcontractor’s laboratories will be used to perform a cGMP pilot run.  A full scale production and purification will
be performed to test the process and produce bulk drug substance.  This drug substance will be used as an
internal reference standard for the following studies:

1.      QC assay development.

2.      QC testing for comparability to previous endotoxin
CC-RE-Lot3.

3.      Drug Substance stability studies. 

The potential
Subcontractor may perform any or all of these studies. The potential
Subcontractor will also perform pilot formulation and lyophilization studies
based on requirements to produce final vialed product
listed in Table 3. 

Milestones 3 &4: Production of cGMP
Endotoxin

The potential Subcontractor
will perform a full scale production and purification to produce cGMP grade
endotoxin including the following activities: 

1.      Controlled fermentation will be conducted in a batch
mode.

2.      Purification will be performed to produce bulk drug
substance. 

3.      QC/QA release of the drug substance.

4.      Formulation, vialing, and labeling of endotoxin drug
product (FVP).

5.      QC/QA release of the FVP.

6.      Stability program for FVP and, if required, bulk
biological substance

7.  Preparation
of a Manufacturing Report (Appendix 1) to be included in     

     submissions
to the US FDA with authorization to cross-reference any required    

     potential
Subcontractor submissions to enable full review of the manufacturing    

     and
testing documents by the US FDA for IND
studies.

Please refer to attachment for tables 1 and 2.

Project Management:

The potential Subcontractor
will describe the facilities to be used to perform the Statement of Work and
will provide a program management plan that includes the structure for project
management, frequency and content of project status communications and the
contents of financial and technical reports. SAIC-F will require technical
reports for each completed development study and manufacturing activity (e.g.,
MCB production, bulk biological substance production) and will require monthly
financial status reports of technical progress and budget expenditures.  The
potential Subcontractor will provide a program schedule and budget that clearly
delineates each program milestone by schedule and cost. SAIC-F will require
review of program deliverables from each milestone prior to authorization to
proceed with the next scheduled milestone.

Quality
Systems and cGMP Compliance:

The potential Subcontractor
will be responsible for compliance with all local, state and federal regulatory
statutes. For specific cGMP compliance, the potential Subcontractor will be
required to enter into a Quality Agreement with SAIC-F.

Responder Instructions:

1)         Any
potential bidder who desires to respond to this RFI, must submit their
intention to the SAIC-F POC below via email NO LATER THAN December 30, 2008, by
4:00 PM Eastern Standard Time.

2)                  Responders must submit
a capability statement describing their organization’s     

      experience and
abilities to further develop the proposed material as described   

      which
includes:  (a) the professional
qualifications, experience, and listing of

      key staff who
may be assigned in the developing/manufacturing of the

      prototype (CV’s
are to be provided); (b) listing of any/all current and relevant

      certifications
from a qualified neutral third-party and contact information; (c)

      a description
of the facilities and other resources available to

     develop/manufacture
the material; (d) an estimate cost broken down in a time

     and material
(T&M) format; (e) an estimated project schedule; and (f) detailed

     project
management plan.

The final
response should include the following Business Information in addition to the
capability statement:

1)                  RFI Number

2)                  DUNS number

3)                  Company Name

4)                  Company Address

5)                  Company Point of
Contacts, Phone, FAX, and Email Address.  POC’s should include individual(s) who is(are) duly authorized in
managing any/all technical issues and/or questions, and individual(s) who
is(are) authorized in managing any/all contractual issues and/or questions.

6)                  Type of Company (i.e.
small business, large business, educational institution, etc.)

      3)         The final date to submit questions for this RFI is 12 noon, January 12,
2009

4)         The last date to submit final responses to this RFI is 3:00PM, January
30,

2009.

Point of Contact

Primary:

Mr. Howard Souder, Jr.,
Subcontract Specialist, Phone (301) 846-5096, Fax (301) 228-4037, Email:  souderhr@mail.nih.gov