DPBS GMP Grade
Dulbecco’s Phosphate Buffered Saline
GMP-compliant DPBS backed by a filed FDA Type IV Drug Master File
GMP (CT-36500) · RUO (P04-36500)
DPBS is a sterile buffered salt solution widely used in cell culture for washing, dilution, and handling of cells and tissues while maintaining physiological pH and osmolarity. PAN-Biotech offers DPBS in multiple variants with or without calcium and magnesium to support different application requirements, including gentle cell handling or workflows where divalent cations must be excluded.
DMF-backed GMP supply. DPBS GMP Grade (CT-36500) is manufactured EU GMP Annex 1–compliant by PAN-Celltech and backed by a filed FDA Type IV Drug Master File – supporting your regulatory submissions for further manufacturing and clinical use. The research grade is available as P04-36500 (500 ml) and P04-361000 (1,000 ml).
Why GMP DPBS
- GMP-compliant – manufactured GMP EU Annex 1-compliant by PAN-Celltech (manufacturer of record).
- FDA Type IV DMF – filed 22 May 2026; supports customer regulatory submissions.
- With / without Ca & Mg – variants for gentle handling or divalent-cation-free workflows.
- Physiological buffering – maintains pH and osmolarity for washing, dilution and cell handling.
Formulation at a glance
| Product | Dulbecco’s Phosphate Buffered Saline (DPBS) |
| Grade | GMP-compliant (GMP EU Annex 1) |
| Regulatory | FDA Type IV Drug Master File, filed 22 May 2026 |
| Variants | With or without calcium & magnesium; 10× concentrate available |
| Typical use | Washing, dilution, cell & tissue handling |
Ordering & grades
Applications
- GMP washing, dilution and cell/tissue handling
- Further manufacturing and clinical workflows requiring DMF-backed buffers
- Divalent-cation-free handling (Ca/Mg-free variant)
- Regulatory submissions leveraging the filed FDA Type IV DMF
Frequently asked questions
Is PAN-Biotech DPBS GMP-compliant?
Yes. DPBS GMP Grade(CT-36500) is manufactured GMP EU Annex 1-compliant by PAN-Celltech. Note: PAN-Biotech uses ‘GMP-compliant’, not ‘GMP-certified’.
Is there a Drug Master File?
Yes. DPBS GMP Grade is backed by an FDA Type IV Drug Master File filed 22 May 2026, which supports customer regulatory submissions.
Are Ca/Mg-free variants available?
Yes. DPBS is offered with or without calcium and magnesium, plus a 10x concentrate, to suit different workflows.
One partner, from research through further manufacturing to GMP. Explore the full GMP-grade catalogue or use the Smart Product Search to find a matched product for your cell line.
Related: GMP-Grade Products overview · DPBS GMP Grade (CT-36500) · Research Grade (P04-36500)