Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JULY 23, 2021 SAM #7174
SOLICITATION NOTICE

65 -- Procurement of an autoMACS Pro Separator

Notice Date

7/21/2021 7:22:10 PM
 

Notice Type

Presolicitation
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

NATIONAL INSTITUTES OF HEALTH NICHD BETHESDA MD 20817 USA
 

ZIP Code

20817
 

Solicitation Number

NICHD-21-213
 

Response Due

7/28/2021 6:00:00 AM
 

Archive Date

08/12/2021
 

Point of Contact

Amber Harris, Fax: 3014803278
 

E-Mail Address

amber.harris@nih.gov
(amber.harris@nih.gov)
 

Description

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to MILTENYI BIOTEC INC for the purchase of an autoMACS Pro Separator. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 334516 with a Size Standard of 1,000. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2021-06 Effective July 12, 2021. This acquisition is conducted under the procedures as prescribed in FAR subpart 13�Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1�Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). PERIOD OF PERFORMANCE Within 30 Days of Award Place of Performance National Institutes of Health� National Institute of Digestive, Diabetes & Kidney Diseases� 50 South Drive Bethesda MD 20892 DESCRIPTION OF REQUIREMENT The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports research on many of the most serious diseases affecting public health. The Institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields, as well as many basic science disciplines.� The Institute's Division of Intramural Research encompasses the broad spectrum of metabolic diseases such as diabetes, obesity, inborn errors of metabolism, endocrine disorders, mineral metabolism, digestive and liver diseases, nutrition, urology and renal disease, and hematology. Basic research studies include biochemistry, biophysics, nutrition, pathology, histochemistry, bioorganic chemistry, physical chemistry, chemical and molecular biology, and pharmacology.� NIDDK extramural research is organized into 4 divisions: Diabetes, Endocrinology, and Metabolic Diseases; Digestive Diseases and Nutrition; Kidney, Urologic, and Hematologic Diseases; and Extramural Activities. �The Institute supports basic and clinical research through investigator-initiated grants, program project and center grants, and career development and training awards. The Institute also supports research and development projects and large-scale clinical trials through contracts. _________________________ NIDDK�s work involves studies to understand how cell-specific transcriptomes that define the differentiated tissues of an organism arise from the same genetic blueprint � the genome. To do this, the NIDDK needs an automated system that allows for positive selection or depletion of cells and biomolecules without affecting their function or viability. The autoMACS Pro Separator is designed for automated and gentle cell separation based on Miltenyi Biotec�s patented MACS Technology. This instrument is designed for the isolation of a variety of cell types from multiple sources, including but not limited to peripheral blood mononuclear cells (PBMCs), whole blood, and buffy coats. It is compatible with many downstream applications such as molecular and functional assays, chimerism analysis, cell culturing, and flow cytometry. PURPOSE AND OBJECTIVES The National Institutes of Health (NIH)�s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has a requirement for the Miltenyi Biotec autoMACS Pro Separator system to be held by the Laboratory of Cellular and Developmental Biology. Our work involves studies to understand how cell-specific transcriptomes that define the differentiated tissues of an organism arise from the same genetic blueprint � the genome. To do this, we need an automated system that allows for positive selection or depletion of cells and biomolecules without affecting their function or viability. � � SALIENT / REQUIRED FEATURES AND SPECIFICATIONS Specifically, the NIDDK requires the following: 1.�� �The autoMACS Pro Separator can separate and label up to 6 samples (for positive or negative selection) sequentially without the need of user intervention.� 2.�� �Separated material can go directly to culture, flow cytometric sorting or analysis, functional studies, or transplantation without detaching the MicroBeads.� 3.�� �The flexibility of the autoMACS Pro Separator allows users to separate manually labelled samples alongside those that have been automatically labelled.� 4.�� �The auto-labeling reagents are the same as those used in manual separations which reduces costs by avoiding the purchase of specialized reagents and allowing the easy translation from manual to automated systems.� 5.�� �Any positive and untouched isolation can be performed to separate target cells from PBMCs, cultured cells, and dissociated tissue. In addition, cells can be directly isolated from whole blood or bone. 6.�� �More than 400 different MicroBeads and Isolation Kits are available. 7.�� �To ensure cell viability and integrity, cells are kept cooled in Chill Racks. 8.�� �Pre-set programs for all MACS� MicroBeads and Isolation Kits ensure accurate sample handling. Sensors constantly monitor the status of the autoMACS� Pro, buffer levels, and column status. This ensures optimal instrument performance and safety of samples and operators. 9.�� �Fully automated. 10.�� �The autoMACS Pro Separator system consists of: ��� �1 x autoMACS Pro Instrument ��� �1 x MACS MiniSampler ��� �1 x MACS Reagent Rack 4 ��� �3 x MACS Chill Racks (Chill 5, Chill 15, Chill 50) ��� �5 x 2 autoMACS Columns ��� �2 x 2 autoMACS Column Substitutes ��� �1 x autoMACS Pro Buffer Combination ��� �Instrument software, user manual and short instructions TASKS AREAS The vendor shall deliver the prescribed equipment items in the correct quantities without damage or manufacturing defect. Independently, and not as an agent of the Government, the contractor shall perform all of the detailed Task Areas listed below: Task Area 1 � Lead time is 30 days ARO. Task Area 2 � Installation and setup will be performed by the vendor. Task Area 3 � The vendor will provide warranty coverage (1 year) beginning when it ships from the factory. Maintenance visits, emergency repairs and associated costs such as parts, labor, and travel are covered. Task Area 4 � Training will be provided by the vendor for up to five (5) people on the day that the instrument is installed. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10�Market Research. �Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined MILTENYI BIOTEC INC to be the only reasonable available source to provide an autoMACS Pro Separator. �� This acquisition was pursued on a sole source basis centered on the fact that the autoMACS system allows for positive selection or depletion of cells without affecting their function or viability. The autoMACS Pro Separator can separate and label up to 6 samples (for positive or negative selection) sequentially without the need of user intervention. Separated material can go directly to culture, flow cytometric sorting or analysis, functional studies, or transplantation without detaching the Microbeads. MACS Products are ideal for rare event isolation. The auto-labelling reagents are the same as those used in manual separation so reducing costs by avoiding the purchase of specialized reagents and allowing the easy translation from manual to automated systems.� MACS Microbead reagents are a colloidal suspension of 50 nm super-paramagnetic nanoparticles (iron) coated with polysaccharide. The Microbeads are directly conjugated to monoclonal antibodies. The autoMACS Pro Separator utilizes a patented column technology. The magnetic field generated by the system�s high-energy magnet is even amplified by each of the dual super-paramagnetic column structures. In addition to amplifying the magnetic field, the columns spread the magnetic field into hundreds of micro-gradient fields. This amplified magnetic field gently retains the Micro-Bead bound cell as they flow through the column, thus allowing the researcher to use a minimal amount of antibody bead complexes. With this unique column-based system, the amount of Microbead-antibody complexes required for cell separation, typically only occupies part of the target epitopes on a cell thus allowing to restrain the cells with fluorochromes recognizing the same epitopes without any loss of intensity. This leaves the remaining epitopes open for normal function or staining with a fluorochrome for analysis. MACS Technology patented columns are optimized in size to bind up to 2x108 target cells from up to 4x109 total cells.� Unique specifications of the autoMACS Pro Separator: ��� �Barcode reader (�code reader�) or touchscreen activated automated cell isolation system with pre-programmed isolation protocols that are utilized by the integrated computer. ��� �Custom cooling sample rack to keep samples cool during the separation process. ��� �Separation time of 3-10 minutes, depending on the program. ��� �Input volume of 100 ul to 50 ml. ��� �Automated system cleaning. ��� �Patented columns: Dual super-paramagnetic, bio-Teflon coated matrix columns that are reusable over a two-week period or up to 100 separations, whichever comes first. ��� �High-gradient magnetic field optimized for cell isolation of very rare populations, frequencies down 10-8. This instrument has been designed and manufactured by Miltenyi Biotec GmbH at Bergisch Gladbach, Germany. �The autoMACS Pro is accompanied by a 1-year original warranty period. The original warranty period will begin the day after the date of installation or 30 days after the shipment date, whichever occurs first. Continued service support of the autoMACS Pro may be obtained at a later date. � Therefore, the procurement of an autoMACS Pro Separator is necessary for continued research analysis. Failure to procure this deliverable from MILTENYI BIOTEC INC would result in a significant loss of research.� CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties� bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.� A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Wednesday, July 28, 2021 to the Contracting Officer, Amber Harris, at amber.harris@nih.gov. Assessment of Capability Lowest Price Technically Acceptable �
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/009d502107594fc6a7a77d9ddfaa9379/view)
 

Place of Performance

Address: Bethesda, MD 20892, USA

Zip Code: 20892

Country: USA
 

Record

SN06069189-F 20210723/210721230131 (samdaily.us)
 

Source

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

---

| FSG Index  |  This Issue's Index  |  Today's SAM Daily Index Page |