RFI on Cell Line Development Services - Sources Sought Notice

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 THE PRESENT TIME. THIS IS STRICTLY MARKET RESEARCH. However, should such a requirement materialize for a formal RFP, no basis for claims against SAIC-F shall arise as a result of a response to this Sources Sought Notice or SAIC-F's use of such information as either part of our evaluation process or in the developing specifications for any subsequent requirement. Any questions concerning this solicitation must be directed through the SAIC-F Point of Contact (SAIC-F POC)

Sources Sought Notice Number: S09-112

Posted Date: February 27, 2009

Response Date: May 1, 2009 by 4:00PM Eastern

Archive date: May 30, 2009

Classification Code: A - Research and Development NAICS: 541711

Set Aside: N/A

Contracting office address: SAIC-Frederick, Inc.
National Cancer Institute at Frederick
92 Thomas Johnson Drive, Suite 250
Frederick, MD 21702-1201

Summary:

A contract manufacturing organization or supplier with the ability to economically develop a mammalian cell line expressing a therapeutic protein including but not limited to chimeric or humanized monoclonal antibodies, antibody fragment fusion proteins, or recombinant cytokines in an established cell line, such as CHO suspension cells, HEK 293 cells, or NS0 cells with stable expression level at 10-50pg/cell/day using a batch, fed-batch, or perfusion process.

Service Requirement:

Potential respondents are to provide detailed description of technical approaches and experience, as well as estimated costs in performing the activities detailed below:

Product Gene

1) SAIC-F would provide a gene sequence of an antibody or antibody fragment fusion with a protein, or a recombinant protein with construct size <10-12KB.
2) Respondents will provide description of sequence analysis and codons optimization for expression in mammalian cells using either direct synthesis or codon optimization techniques.

Product Expression Regulation

1) Respondents will provide a description of promoter; e.g., CMV or equivalent strong mammalian cell promoters.
2) Respondents will use a leading peptide to express the protein as secreted form.
3) Respondents will use a terminator or terminators to enhance target gene transcription.
4) Respondents will provide details on removal of introns to improve transcriptional yield where acceptable.

Cloning Requirement

1) Respondents will describe a selection system (GS or dhfr-) to be used in the expression system. Alternatives to the use of a selection system may also be described by the respondent.
2) Respondents will describe an additional selection to facilitate enriching high producer may be described; however SAIC-F requires to use a system previously approved by FDA for clinical trials.
3) Full length plasmid sequencing is required. A high transgene copy number in the cell line is preferred but not required.

Cell Line Requirement

1) Respondents will describe the proposed host cell line, such as CHO suspension cells, HEK 293 cells, or NS0 cells.
2) Respondents will describe how the host cell lines are qualified for use.
3) Respondents will provide how sequencing of the promoter and transgene coding region in the selected high producer is performed. Messenger RNA sequence and information regarding the location of the transgene(s) in the host cell is preferred but not required.

Procedure Requirement

1) Respondents will describe procedures for how the constructed plasmid DNA is transfected into a selected cell line; to include:
a) A stable transfection pool.
b) Single cell cloning methods.
2) If a selection system is used in expression, a reasonable transfected clone number (depend upon the system) is required; please describe. If there is no selection system is used to enrich high producer, more than 1000 single clones are required to select for expression screening.
3) Responder will describe procedures to evaluate cell growth and productivity based on respondent's selection on medium and culture condition.

Cell Growth and Productivity Requirement

1) Respondents will describe how the following that would be delivered:
a) A serum-free or protein-free medium adaptation.
b) Cell growth to reach 5-10 a 106 cells/mL.
c) Cell doubling time in the range of 20-30hour.
d) Viability of culture greater than 90%.
e) More than 5 days for batch process or more than 9 days for fed-batch
process.
f) Productivity of greater than 10pg/cell/day is required.
2) Respondents will describe methods used to characterize the expression candidate protein or previous experience working with clients to achieve characterization.

Key Requirements to be considered for the areas above include:

1) A traceable history of the host cell used in the study.
2) A clear history of the plasmid vector used in the study.
3) A cell culture medium that is GMP compliant.
4) Generation of a cell line expressing a product is well documented.
5) All the sequence information of the plasmid and cell line to be made available in standard electronic formats.

Responder Instructions:

Responders must submit a capability statement (30 page limitation, excluding resumes) describing their organization's experience and abilities to provide the materials and services as described which includes: (1) a summary of list of past performance with references; (2) a brief description of the professional qualifications and experience of key staff who may be assigned in the production of the materials and delivery of services (CV's may be provided); (3) listing of any/all current and relevant certifications from a qualified neutral third-party and contact information; (4) a general description of the facilities and other resources needed to provide the materials and services; (5) demonstrated ability to produce the materials & services; and (6) an estimated cost broken down in a Time and Material (T & M) format of defined materials and services.

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

1) Sources Sought Number
2) DUNS number
3) Company Name
4) Company Address
5) Company Point of Contact, 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, 8(a), woman-owned, veteran-owned, etc.) as validated by the Central Contractor Registration (CCR). All responders must register on the CCR, located at http://www.ccr.gov/index.asp.

The final date to submit questions for this RFI is 12 noon on April 17, 2009

The last date to submit final responses to this RFI is 3:00 PM, May 1, 2009

Point of Contact

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