AN12--Notices of Sources Sought Material Generation and Molecular Evaluation of 3 Antibodies Boise VAMC

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Contract Opportunity

Notice of Sources Sought

The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), and Small Businesses interested and capable of providing the services requested, as well as any large businesses. The results from this source sought notice will be used to determine the appropriate set-aside.

The intended contract is a firm-fixed price service contract.

The SBA Non-Manufacturer Rule is not applicable as the intended contract is for services.

The Department of Veterans Affairs, NCO20 is looking for vendors able to perform in silico developability assessment, comprehensive biophysical profiling and multi-attributed method (MAM) analysis of three human monoclonal antibodies with therapeutic potential. See Statement of Work below.

Statement of Work:
Contract Title
Material Generation and Molecular Evaluation of Three Antibodies
Background
Biophysical characterization is a critical component of monoclonal antibody development and is essential for selecting a lead candidate suitable for clinical translation. While in vivo efficacy is necessary, it is not sufficient to ensure that an antibody can be manufactured, formulated, and delivered effectively at clinical scale. To address this, Research Services of the Boise VA Medical Center is seeking a contractor to perform in silico developability assessment, comprehensive biophysical profiling and multi-attributed method (MAM) analysis of three human monoclonal antibodies with therapeutic potential. Their advanced analytics will provide high-resolution data to guide selection of a lead candidate that is not only therapeutically effective but also exhibits. Ultimately, this work enables rational deselection of our lead antibody based on a more thorough understanding of its translational feasibility.
Scope
In silico analysis of the 3 parental antibodies

Specific Tasks to be performed on each antibody
in silico structure modeling
Sequence evaluation across family, against germline and in conjunction with structures
Germline background
Possible sequence post-translational modifications
Possible agretope motifs for immunogenicity
Stability violation
Structure-based surface analysis for aggregation, viscosity and clearance rates

Deliverables
Sequence level report detailing regions, alignments, attributes and potential liabilities

Generation of Material for biophysical characterization and MAM
Expression vectors will be designed based on protein sequence information provided by VA
The designed vectors will be transiently transfected into HEK293 cells
Generate antibodies via small-scale expression protocols
Purify expressed antibodies via protein A

Deliverables
Sufficient material to perform subsequent contracted analyses
Access to CHO host cell expression systems

Biophysical Characterization and MAM Analysis of the Parental Molecules

Specific Tasks to be performed on each antibody:
Conformational and stability methods: low pH hold, size exclusion chromatography (SEC), thermal hold/T(agg), chemical unfolding, differential scanning fluorimetry (DSF)
Colloidal stability methods: self-interaction nanoparticle spectroscopy (SINS), relative solubility analysis (RSA), Zenix column chromatography, polyspecificity assays
Labile site analysis by MAM spectrometry method: identification of post-translational modifications such as clipping, deamidation, oxidation for potential editing during molecule optimization

Deliverables
Assessment analytical data package for the contracted antibodies
Access to molecule assessment tools for use in tandem with the data package results

Performance Monitoring (if applicable)
TBD
Security Requirements
The contractor employees will not have the need to access the VA facility or the VA Network. There will be no exchange of information with the contractor bearing PII/PHI. The C&A requirements do not apply, and a Security Accreditation Package is not required

6. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI)
No GFE or GFI will be needed or provided, since all analysis will be performed off station at the contractor s facility.

7. Other Pertinent Information or Special Considerations
The MAM analysis services sought is a relatively new analytical strategy with a limited number of contractors possessing the expertise to perform the work

Identification of Possible Follow-on Work
Does not apply
Identification of Potential Conflicts of Interest (COI)
No known potential conflicts of interest with current contracting information but can be reevaluated after RFQ contractors are identified.
Inspection and Acceptance Criteria
The requestor will monitor the results of the analysis and determine whether contracted services have been fulfilled.
Risk Control
All contractor performed analysis will occur in their own facilities with trained staff.
Place of Performance
Contractor s Facility
Period of Performance
From date of award approximately 6 months
Delivery Schedule
Once the contract is awarded, the required information will be dispatched from the VA to the contractor with the analysis data package delivery time of approximately 4 -5 months.
Requestor will sign off on the completion of contracted work and maintain a copy of the receipt of services for documentation.
Required Information in Your Response to Sources Sought:
In order to be considered a valid source that can impact the set-aside determination of a possible future solicitation, potential contractors shall provide, at a minimum, the following information to peter.park2@va.gov by below response deadline:

1) Company name, address, and point of contact, phone number, e-mail address, and UEI.

2) Please identify your company s size in comparison to the anticipated North American Industry Classification System (NAICS) code 541714 Research and Development in Biotechnology (except Nanobiotechnology). To be considered a small business your company must have equal or less than 1,000 employees. This notice is to determine the marketplace for this specific requirement. Please check one of the following:

[ ] yes [ ] no Service Disabled Veteran Owned Small Business (SDVOSB)
[ ] yes [ ] no Veteran Owned Small Business (VOSB)
[ ] yes [ ] no Small Business Manufacturers
[ ] yes [ ] no All other Small Business (SB)
[ ] yes [ ] no Other than Small Business

3) Any Service-Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must provide a SBA certification and be registered with U.S. Small Business Administration Veteran Small Business Certification (VetCert) located at https://veterans.certify.sba.gov/.

4) Please provide a courtesy quote in response to this request to evaluate price reasonableness for any set-aside determination.

5) Capabilities Statement addressing the requirements in the Statement of Work to include:
References for similar services currently being provided or previously provided at the required service levels as outlined in the Statement of Work.
The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued.

Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM located on the web at www.sam.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application in the System for Award Management (SAM).

Service Address:
Boise VA Medical Center
Search Service
500 W Fort St
Boise, ID 83702

Point of Contact:
Peter Park
Contracting Officer
peter.park2@va.gov

Response Deadline:
05/15/2023 by 3:00pm Pacific Time

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