Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JUNE 24, 2023 SAM #7879
SOLICITATION NOTICE

66 -- SCD-IIB welder wafers, product # 3NCC987, 60 cases

Notice Date

6/22/2023 12:56:07 PM
 

Notice Type

Presolicitation
 

Contracting Office

NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
 

ZIP Code

20892
 

Solicitation Number

NOI-NIAID-23-2180020
 

Response Due

6/27/2023 2:00:00 PM
 

Archive Date

07/12/2023
 

Point of Contact

Dana Monroe, Phone: 4063759814
 

E-Mail Address

dana.monroe@nih.gov
(dana.monroe@nih.gov)
 

Description

PRE-SOLICITATION NOTICE� **NOTICE OF INTENT NOI-NIAID-23-2180020� NAICS � 5339112 This is a Notice of Intent, not a request for proposal.� The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Terumo BCT, Inc to procure SCD-IIB welder wafers, product # 3NCC987, which are proprietary designed thermo-conductive copper plates that interface with the SCD-IIB welders. The mission of the Vaccine Production Program (VPP) is rapid, reliable development of investigational vaccine candidates and other therapeutic biologics that are suitable for use in clinical trials.� The Cell Culture Development (CCD) team commits to the VPP�s mission through study and optimization of cell culture options followed by scaling up successful culture production techniques for vaccine and therapeutic candidates.� Successful process development is transferred to a GMP facility to manufacture materials for phase 1 Clinical trials. A fundamental and essential element of CCD process development is the use of 3, 15, and 50 liter bio-reactors.� This array of instrumentation enables scientific staff to study the effects of various growth and scale up conditions via the production and harvest of cell culture process runs.� This technology requires the transfer of nutrients and the cells themselves into the bio-reactor throughout a seven to fourteen day process.� Said transfer must be performed under sterile conditions or the bio-reactor may become contaminated and culture will fail. To prevent bio-reactor failure, a closed and sterile circuit must be maintained when adding or removing feed stock, cells, or other samples.� The CCD team requires a tubing welder than can rapidly and effectively create reliable sterile welds between tubes while remaining small enough to not impact our limited laboratory storage options and portability requirements.� The SCD-IIB tubing welder equipped with SCD-IIB wafers creates strong, dependable tubing welds within a closed system which significantly mitigates contamination and product loss and serves as a critical asset to the CCD team.� This welder speeds up production time with sterile welds created in about 30 seconds, as opposed to the 1.5 to 3 minutes required by competitors.� Its small form factor and lightweight design also exceeds options put forth by competitors enabling better use of our limited space and a more ergonomic option for our staff.� SCD-IIB units have been used by the CCD team for over 10 years, meaning we not only have high confidence in the reliability and efficacy of these machines, but they are known to match our facility fit in terms of power supply, SOP related documentation, and employee training. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply or service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. �All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-23-2180020 to Dana Monroe at dana.monroe@nih.gov, by 5:00pm EST Tuesday, June 27, 2023.� All responses received by the closing date of this synopsis will be considered by the Government.� A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/4862c6d1abca4263ac51b4e30666e70c/view)
 

Place of Performance

Address: Gaithersburg, MD 20878, USA

Zip Code: 20878

Country: USA
 

Record

SN06725220-F 20230624/230622230118 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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