NMRC N3239824Q8349 JAA.pdf
PDF 143 KB Posted
- Attached to
- Antibody-Drug Conjugates (ADCs) Services
- Solicitation number
- N3239824Q8349
About this file
This document is a Justification and Approval (J&A) for the use of other than full and open competition to award a single, firm-fixed-price contract to Creative Biolabs, Inc. to provide services for making antibody-drug conjugates (ADCs) for a MIDRP-funded research proposal.
The key details are: NMRC has been awarded a grant to develop ADCs as a therapeutic strategy to treat dengue infection. The contract will cover three essential parts: 1) IgG purification, 2) linker payload synthesis and conjugation, and 3) standard product quality control. Creative Biolabs was selected after market research as they offered the full service at a competitive price of $XX,XXX per 1mg ADC production. The contracting officer will perform a cost analysis to determine fair and reasonable pricing. No other suitable vendors expressed interest in providing the full service. This requirement will be procured under FAR Part 12 for commercial items.
View the file
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
JUSTIFICATION AND APPROVAL
FOR USE OF OTHER THAN FULL AND OPEN COMPETITION
1. Contracting Activity.
Contracting Activity: Naval Medical Logistics Command (NMLC), Acquisition Management Directorate, Code 02, 693 Neiman Street, Fort Detrick, MD 21702, is acquiring on behalf of the requesting agency:
Naval Medical Research Command (NMRC), 503 Robert Grant Avenue, Silver Spring, MD 20910.
2. Description of the Action Being Approved.
Approval is requested to award a single, firm fixed price contract to Creative Biolabs Inc., 17 Ramsey
Road, Shirley, NY 11967, USA to provide services for making antibody-drug conjugates for a MIDRP funded research proposal.
3. Description of Supplies/Services.
NMRC has been awarded a grant (grant # MI240093) to develop antibody-drug conjugates as a therapeutic strategy to treat dengue infection. Antibody-drug conjugates (ADCs) are a class of engineered therapeutics composed of an antibody linked to a biologically active drug or cytotoxic compound (also termed payload) via a chemical linker. This contract is to cover a service of ADC production. The service includes three essential parts: 1. IgG purification; 2.
Linker payload synthesis and conjugation; 3. Standard product QC. The company Creative
Biolabs was selected as a contract after market research as detailed in Section 6.
The company will provide the following services:
A. ADC Production services - 1 mg --------------------------------------------------- $XX,XXX
• Antibody Provided by the customer, Purification by CBL
• Linker Payload Synthesis (mc-vc-PAB Homoharringtonine) provided by CBL
• Conjugation Service
B. ADC Production services - 1 mg ---------------------------------------------------- $XX,XXX.
• Antibody Provided by the customer, Purification by CBL
• Linker Payload Synthesis (mc-vc-PAB Moxidectin) provided by CBL
• Conjugation Service
C. The standard QC includes the characterization of ADCs by Mass Spectrometry as below: -- XXXX
-SEC for aggregation (Agg%)
-HIC for unconjugated antibody (UmAb%)
-LC-MS or HIC for DAR
D. ICE PACK SHIPPING & HANDLING --------------------------------------- $XXXX
4. Statutory Authority Permitting Other Than Full and Open Competition.
10 U.S.C. 2304(c)(1), One source or limited sources.
5. Rationale Justifying Use of Cited Statutory Authority.
The vendor provided needed services with competitive price and acceptable timeline for delivery.
6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.
From March 2024 to April 2024, we have solicited more than 10 companies and the following companies had returned the solicitations with services and prices:
Companies
Contacts
Estimate provided
Price
Reasons for selection
Cellmosaic.co m
Yumei Huang
No yhuang@cellmosaic.com
Millipore Brandon Joachim No
Pearl River
Laboratories lugene.maher@pearlriverlabs.co m amar.prashad@pearlriverlabs.com
CreativeBiolabs
Stella.young@creative-bioabs.com
Erica.Lawson@creative-biolabs.com
Yes
Full service provided. $13,960 per 1 mg protein purification and
ADC production including IgG purification. No set up fee.
Yes. Reason:
They offered full service for protein purification and ADC production.
Biosynthesis heidi@biosyn.com
Yes
$7500 only per 1mg ADC production not including IgG purification.
Requires a setup fee of $1500.
No. Reason:
They did not provide service for protein purification.
Sterlingpsl.com judy.boan@sterlingpsl.com No No
BOC Sciences
Michael
<service14@bocsci.com>
Jess Poe
<service22@bocsci.com>
Iris <tech26@bocsci.com>
7. Determination of Fair and Reasonable Cost.
mailto:yhuang@cellmosaic.com mailto:lugene.maher@pearlriverlabs.com mailto:lugene.maher@pearlriverlabs.com mailto:amar.prashad@pearlriverlabs.com mailto:Stella.young@creative-bioabs.com mailto:Stella.young@creative-bioabs.com mailto:heidi@biosyn.com mailto:judy.boan@sterlingpsl.com mailto:service14@bocsci.com mailto:service22@bocsci.com mailto:tech26@bocsci.com
The contracting officer will perform a cost analysis in order to determine that the anticipated cost to the Government of the services covered by this J&A will be fair and reasonable. Pre-negotiated or audited rates will be used where available. CWRU will be required to submit certified cost or pricing data in accordance with Federal Acquisition Regulation 15.403. A certificate of current cost or pricing data will be required at the conclusion of negotiations.
8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.
Research was done by internet and contacting vendors to get the estimates through emails and online calls.
9. Other facts supporting the use of other than full and open competition.
If other suitable vendor(s) became available, a full and open competition may be considered.
10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.
To date, no other sources have written to express an interest for a full service. Most vendors (some are not listed above) only provide partial service.
11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.
12. Point of Contact.
The point of contact at the Naval Medical Research Center, Silver Spring, MD, regarding the contents of the sole source justification is Shamai M. Carter, who may be reached at (301) 319- 7182.
TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED
BY NAVSUP 4200.83 series
I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.
Technical Cognizance
JENKINS.SARAH.ANN.1500933581
Digitally signed by JENKINS.SARAH.ANN.1500933581
Date: 2024.05.01 09:48:13 -04'00'
LCDR Sarah A Jenkins Phone Date
Department Head
DSD/NMRC
Requirements Cognizance
LCDR Sarah A Jenkins Phone Date
Department Head
DSD/NMRC
CONTRACTING OFFICER CERTIFICATION
I certify that this justification is accurate and complete to the best of my knowledge.
CARTER.SHAMAI.M.16 Digitally signed by
24726649 CARTER.SHAMAI.M.1624726649
Date: 2024.05.09 12:10:50 -04'00'
(301) 319-7182 5/9/2024
Shamai M. Carter Phone Date
Contracting Officer
JENKINS.SARAH.AN Digitally signed by
N.1500933581
JENKINS.SARAH.ANN.1500933581
Date: 2024.05.01 09:48:31 -04'00'
File details come from the government source that posted it. Updated .