HUNK Automated Protein Denaturation Platform Brand Name or Equal

Part 1 - Description

The U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has a requirement for a HUNK Automated Protein Denaturation Platform or equal instrument for assessing the quality and safety of protein therapeutics. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-86. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing. The associated small business standard is 500 employees. This requirement is for a small business set-aside.

Part 2 - Supplies or Services and Prices/Costs

Purchase Order Type: Firm-Fixed Price
Base Year
Manufacturer Product Code Description Quantity Price
UnChained Labs 300-1029 HUNK Automated Protein Denaturation Platform
UnChained Labs 302-1035 Silver Tray for HUNK Platform
UnChained Labs 304-1031 Installation and training
Shipping
One (1) year warranty on parts, labor, and travel
Total Firm-Fixed Price

Option Years
Option Year Description Price
1 Service Agreement
2 Service Agreement
3 Service Agreement
4 Service Agreement
Total Firm Fixed Price

The total price for the base and four option years is

tiny_mce_marker

___________.
Part 3 - Description/Specifications

3.1 Background
The Division of Product Quality Research (DPQR) conducts research assessing the quality and safety of protein therapeutics. One particularly critical aspect of protein characterization is the assessment of structural stability as a function of formulation and/or buffer content. To summarize, protein stability is heavily impacted based on the formulation or buffer used for protein suspension. In the context of protein therapeutics, it is critical to understand exactly how formulations impact protein stability. Complete understanding of formulation-related stability is important for downstream optimization. DPQR has a requirement for an instrument that efficiently assesses the stability impacts of differing formulations and buffers.

3.2 Statement of Work/Salient Characteristics

The instrument shall perform the following:
• makes ΔG (Gibbs free energy) determinations
• provides the operator with selection methods to perform protein construct screening, formulation screening and optimization, excipient screening, aggregation determinations, or ligand binding determinations
• software shall provide for the analysis of complete stability and aggregation data
• data shall be exportable in a number of formats such as csv, ssv, tsv and txt or any format readable in XL, JMP, and Sigmaplot

Minimum protein concentration per ΔG 25 μg/mL IgG (protein dependent)
Typical volume required per ΔG 1 mL
Time to measure each ΔG Average 1 hour
Maximum unattended ΔG measurements 96
Experiment temperature operating range Constant 2 °C above ambient to 30 °C (+2 °C)
Automatic formulations preparation Up to 12 formulations for each of 8 series, total of 96 conditions
Protein stock temperature 4 °C to ambient
Fluorescence excitation and emission range 190-890 nm ex, 200-900 nm em photomultiplier
Fluorescence detection dynamic range Five orders of magnitude
Environmental conditions Temperature range: 18-28 °C
Physical 56 cm W x 71 cm D x 87 cm H, 91 kg
Electrical Auto switching power supply, voltage 100-240 V AC, 50-60 Hz
1. Delivery, Installation, Training and Warranty:
• Installation shall include of the installation of the system and all components, as well as calibration, quantification, and software installation
• Shall include a demonstration/training for lab personnel
• Shall include a warranty for at least one (1) year from date of installation which covers all labor, parts, and travel expenses required for repairs for equipment and software. Technical support and troubleshooting assistance shall be provided via phone, email, or live-chat interface.

3.3 Optional Service Agreement

The FDA shall have a unilateral right to exercise optional periods to continue the service agreement described below:

The offerors pricing for optional service agreement shall include coverage of labor, parts and travel expenses.

Parts- The service plan will use Original Equipment Manufacturer (OEM) certified parts.

Services On-Site- The contractor will initiate corrective maintenance/repairs within 48 hours from the service call. The repairs will be completed within 72 hours from the on-site arrival of the technician/service engineer. There will be no limit to the number of on-site repair service visits. The service shall be delivered by an authorized OEM service provider.

Services Off-Site- Technical support and troubleshooting assistance will be provided by the contractor via phone, email, or live-chat interface within 1 hour of initial contact.

Part 4 -Performance and Deliverables

4.1 Place of Performance and Work Hours

All applicable equipment is located at the location listed below. Normal workdays are Monday through Friday except US Federal Holidays. Work hours are typically from 8 am to 5 pm (et). Service visits shall be coordinated with TBD, see below.

Location and Point of Contact:
Food and Drug Administration
White Oak Campus
10903 New Hampshire Avenue
Silver Spring, MD 20993

ATTN: TBD

The HUNK system will be delivered to the WO Bldg 62 Loading Dock and transported to WO bldg 64 room 1083 for assembly.
4.2 Period of Performance

The equipment shall be delivered by June 1, 2016. The warranty shall start when equipment is installed and accepted by FDA and be in effect for one year.

Optional Periods

Deliverable Period of Performance
Option Period 1 -Service Agreement To begin 1st year following receipt of equipment
Option Period 2 -Service Agreement To begin 2nd year following receipt of equipment
Option Period 3 -Service Agreement To begin 3rd year following receipt of equipment
Option Period 4 -Service Agreement To begin 4th year following receipt of equipment

Part 5 -Contract Administration

5.1 Representative's
The Contracting Officer's Representative (COR) will perform inspection and acceptance of materials and services to be provided.

For the purpose of this PART, (COR TBD) is the authorized representative of the Contracting Officer.

The COR is responsible for the following as required by this order: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

The contact information for the Contracting Officer is the following:

Sean Wybenga
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
5630 Fishers Lane
Rockville, MD 20857
Sean.Wybenga@fda.hhs.gov;
(240) 402-7629

The contact information for the Contract Specialist is the following:

Lisa Yaw
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
5630 Fishers Lane
Rockville, MD 20857
Lisa.Yaw@fda.hhs.gov;
(240) 402-4018