S02 - Amendment 36C26025Q0592 0002.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 4

531-25-4-325-0065

36C260

Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

36C260

Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

To all Offerors/Bidders

36C26025Q0592

06-04-2025

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 07-02-2025 3:00PM PDT

531-365/60161-325-810300-2580 810010175

X 1

The Statement of Work Change: Below deliverable under 3C is removed. See updated Statement of Work in Page 2.

• Access to molecule assessment tools for use in tandem with the data package results

RFQ response deadline is now extended from 06/18/2025 to 07/02/2025 at 3:00PM PDT.

Peter Park Contracting Officer

VA-VHA-RPOW-2025-0039

CONTINUATION PAGE

B.4 STATEMENT OF WORK

1. Contract Title Material Generation and Molecular Evaluation of Three Antibodies

2. 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.

3. Scope A. 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

B. 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

• Sufficient material to perform subsequent contracted analyses

• Access to CHO host cell expression systems

C. 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

• Assessment analytical data package for the contracted antibodies

• Access to molecule assessment tools for use in tandem with the data package results

4. Performance Monitoring (if applicable) The primary point of contact (POC) will be Sarah Hobdey, PhD. They will be responsible for monitoring the progress of the contract work.

5. 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

8. Identification of Possible Follow-on Work Does not apply

9. 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.

10. Inspection and Acceptance Criteria The requestor will monitor the results of the analysis and determine whether contracted services have been fulfilled.

11. Risk Control

All contractor performed analysis will occur in their own facilities with trained staff.

12. Place of Performance

Contractor’s facility

13. Period of Performance

From date of award – approximately 6 months

14. 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.

B.4 STATEMENT OF WORK