SOW_CDER-2025-127932_final.pdf
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- Attached to
- Purchase of FY25 Nanion Consumables
- Solicitation number
- CDER-2025-127932
About this file
This Statement of Work (SOW) details the U.S. Food and Drug Administration's requirement for Nanion consumables to perform ion channel pharmacology experiments using a SyncroPatch 384 automated patch clamp system. The procurement involves four sequential deliveries of specific laboratory consumables, each spaced three months apart, including 48 NPC-384 low resistance chips for patch clamp recordings, internal and external recording solutions, and standard solutions. The contract has a 12-month base period with a potential 12-month option, and deliveries will be made to the FDA facility in Silver Spring, MD.
Key technical requirements include specialized consumables for electrophysiological research, focusing on studying electrical properties of cells and ion channel proteins. The Division of Applied Regulatory Science (DARS) needs these specific Nanion-brand consumables to maintain research continuity and enable consistent data comparison. The contractor is responsible for packaging, shipping, and coordinating deliveries with the Technical Point of Contact (TPOC), with strict requirements to schedule delivery within 7 days of award and provide tracking information via email for each shipment.
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Statement of Work (SOW)
CDER-25-127932 – Office of Clinical Pharmacology Purchase of Nanion consumables to perform ion channel pharmacology experiments using SyncroPatch 384 automated patch clamp system
BACKGROUND:
Electrophysiology is the study of the electrical properties of cells and tissues in the body. It involves recording voltage signals or current flow resulting from ions moving across ion channel proteins on the cell membrane. Because functions of excitable cells in the body (e,g., in the brain and heart) rely on the cells’ abilities to generate electrical signals, drugs and diseases that affect ion channels will ultimately affect these organ functions.
The Division of Applied Regulatory Science (DARS) has an existing automated high throughput patch clamp system (HTS) SyncroPatch 384 manufactured by Nanion to characterize drug effects on ion channels to address mission-critical, regulatory questions pertaining to drug safety and efficacy. Operation of this instrument requires the use of proprietary recording chips and other consumable made by Nanion. To enable continued research and data consistency (to enable comparison with historical in-house data), this requirement is for brand name – Nanion-specific consumables to continue DARS ion channel research program.
1. REQUIREMENTS
1. NPC-384 low resistance and 8X chips for patch clamp recordings.
2. Internal, external recording solutions for recording and additional divalent cation solutions for solution adjustment.
3. These consumables including the recording plates are perishable. Hence the items are to be delivered 3 months apart (see below).
First delivery (15 days from the date of award)
Description Part/Product # Quantity
NPC-384 low resistance Chips for patch clamp recordings. 22 1001 48
Internal KF 110/Solution 08 3007 2
External [-]Ca2+ [-]Mg2+/Solution 08 3003 1
External Standard Ca 10/Solution 08 3012 2
External Standard/Solution 08 3001 4
Second delivery (three months after the first delivery)
# Quantity NPC-384 low resistance Chips for patch clamp recordings. 22 1001 48
Internal KF 110/Solution 08 3007 2
External [-]Ca2+ [-]Mg2+/Solution 08 3003 1
Third delivery (three months after the second delivery)
# Quantity NPC-384 low resistance Chips for patch clamp recordings. 22 1001 48
Internal KF 110/Solution 08 3007 2
External [-]Ca2+ [-]Mg2+/Solution 08 3003 1
Fourth delivery (three months after the third delivery)
# Quantity
NPC-384 low resistance Chips for patch clamp recordings. 22 1001 48
Internal KF 110/Solution 08 3007 2
External [-]Ca2+ [-]Mg2+/Solution 08 3003 1
2. DELIVERABLES / SPECIFIC TASK
Items Activity Description Responsibility
1 NPC-384 low resistance Chips for patch clamp recordings.
Deliver four batches 48 consumable, each delivery should be three months apart.
Contractor
2 Internal KF 110/Solution Deliver four batches 2 consumable, each delivery should be three months apart.
Contractor
3 External [-]Ca2+ [-]Mg2+/Solution Deliver four batches 1 consumable, each delivery
Contractor should be three months apart.
4 External Standard Ca 10/Solution Deliver four batches 2 consumable, each delivery should be three months apart.
Contractor
5 External Standard/Solution Deliver four batches 4 consumable, each delivery should be three months apart.
Contractor
6 Pack & Ship Pack & deliver each batch to the delivery location specified in SOW
Contractor
3. PERIOD OF PERFORMANCE
12 months from the date of award with one 12-month option to be exercised at the Government’s discretion.
4. DELIVERY ADDRESS
US Food and Drug Administration 10903 New Hampshire Ave, WO 64 Rm 2014 Silver Spring MD 20993
Attn: Jun Zhao and Vinay Indikuda
Technical Point of Contact (TPOC): Wendy Wu (wendy.wu@fda.hhs.gov) / (301) 796-
Vendor will contact the TPOC by phone or email to schedule delivery within 7 days of the award date.
Deliveries must be coordinated with the TPOC prior to shipment. No deliveries will be accepted without prior authorization from the TPOC.
Vendor must notify recipient via email with tracking information when batches ship.
| background: |
| 1. REQUIREMENTS |
| 2. DELIVERABLES / SPECIFIC TASK |
| 3. Period of Performance |
| 4. Delivery address |
File details come from the government source that posted it. Updated .