DPBS, w/o: Ca and Mg, GMP grade

DPBS 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 GMP-compliant according to EU Annex 1 by PAN-Celltech GmbH. Combined with a very low endotoxin level, high batch-to-batch consistency and comprehensive documentation, DPBS GMP grade 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.

Typical Applications

• 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

Product Features

• Manufactured by PAN-Celltech GmbH, GMP-compliant according to EU Annex 1
• Active FDA Type IV DMF (MF044371), referenceable via Letter of Authorization
• GMP-compliant excipient manufacturing, confirmed in audits by leading pharmaceutical and biotech companies
• Ready-to-use – immediately applicable
• Very low endotoxin content
• High batch-to-batch consistency and process reliability