Introduction
Dulbecco's Phosphate-Buffered Saline (DPBS) without calcium chloride and magnesium chloride.
The main purpose of buffered salt solutions is the maintenance of pH and osmolarity in cell culture applications as well as providing essential inorganic ions. These solutions are usually used for washing tissues and cells. Often they are combined with other agents in cell and tissue treatment.
GMP Grade
PAN-Biotech DPBS, w/o: Ca and Mg, GMP Grade is a ready-to-use, phosphate-buffered saline solution designed for direct use in GMP-regulated clinical and industrial applications. It ensures reliable maintenance of pH and osmolality and provides essential inorganic ions required for safe and reproducible cell handling.
The GMP grade version is based on the well-established formulation of the standard DPBS solution and is manufactured under strictly controlled GMP conditions. Combined with a very low endotoxin level, high batch-to-batch consistency and comprehensive documentation, DPBS GMP represents a reliable ready-to-use solution that can be immediately implemented in sensitive manufacturing and clinical workflows without additional preparation steps.
Active FDA Type IV Drug Master File
DPBS GMP grade (CT-36500) is backed by an active FDA Type IV Drug Master File (DMF No. MF044371). Manufacturer and DMF holder is PAN-Celltech GmbH, Aidenbach, Germany. The DMF is listed with the FDA and can be referenced in your own submission via a Letter of Authorization.
This gives users an additional reference basis for their own regulatory submissions and increases traceability when used in particularly sensitive areas such as clinical cell and gene therapy or biopharmaceutical production – with no change to formulation, quality, or order number.
Application
- Washing solution for cells and tissues under GMP conditions.
- Clinical cell processing and cell therapy.
- Cell and gene therapy workflows.
- Vaccine and biopharmaceutical manufacturing.
- Carrier and dilution buffer for active substances and reagents.
Features
- Manufactured in compliance with Good Manufacturing Practice (GMP), confirmed in audits by leading pharmaceutical and biotech companies.
- Active FDA Type IV DMF (MF044371), referenceable via Letter of Authorization.
- Ready-to-use – immediately applicable.
- Very low endotoxin content.
- High batch-to-batch consistency and process reliability.
Composition
| Component | Concentration |
| Potassium chloride: | 200.00 mg/l |
| Potassium dihydrogen phosphate: | 200.00 mg/l |
| Sodium chloride: | 8,000.00 mg/l |
| di-Sodium hydrogen phosphate anhydrous: | 1,150.00 mg/l |
Specifications
Cat. No. CT-36500
| Quality: | GMP Grade (EU Annex 1) |
|---|---|
| Bicarbonate: | Without Sodium Bicarbonate |
| Ca/Mg: | Without Ca and Mg |
| Concentration: | 1x |
| Liquid / Powder: | Liquid |
| Phenol Red: | Without Phenol Red |
| Product Category: | Balanced Salt Solutions |
| Product Type: | DPBS |
| Size: | 500 ml |
| Endotoxin: | < 1 EU/ml |
| Sterile: | Yes |
| Storage Temperature: | +2°C - RT |
| Manufacturer: | PAN-Biotech GmbH / PAN-Celltech GmbH |
| Country of Origin: | Germany |
Documents
- Product Datasheet (PDS)
- Certificate of Analysis (CoA) - Example Version
- Material Safety Data Sheet (MSDS)
- PAN-Biotech GMP Product Factsheet
Related Products
- RUO Version: PAN-Biotech DPBS, without Ca and Mg
- PAN-Biotech GMP Grade Cell Culture Products
- PAN-Biotech DPBS, with Ca and Mg
- Balanced salt solutions
Ilex Life Sciences LLC is an authorized distributor of PAN-Biotech / PAN-Celltech products.