DPBS w/o Ca & Mg, GMP grade

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. It is also one of the most broadly used process liquids in biologics manufacturing – from upstream cell handling to downstream washing, dilution, buffer exchange and formulation – across every major modality.

DMF-backed GMP supply. GMP DPBS (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 (1000 ml).

Used across the whole process. Beyond upstream cell handling, DPBS is a workhorse in downstream processing – for buffer exchange and diafiltration, column and membrane wash, sample dilution, resuspension of pellets and intermediates, size-exclusion running buffer, and as a physiological base for handling and formulation. Its defined, low-interference composition makes it broadly compatible across antibody, vaccine, mRNA and cell & gene therapy workflows.

Why DPBS GMP grade

• 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

Ordering & grades

Other pack sizes are available on request.

In the process – by application (upstream & downstream)

DPBS is one of the most broadly used process liquids. It appears at many steps across all four biologics platforms:

Monoclonal antibodies

• Cell handling (seed & expansion, USP) – washing and resuspension at physiological pH/osmolarity.
• Buffer exchange / diafiltration – working buffer for UF/DF.
• Column & membrane wash – equilibration and wash.
• SEC polishing – running buffer.
• Handling / dilution – dilution and resuspension of intermediates.

Vaccines

• Cell handling – washing and resuspension.
• Harvest / clarification – wash and dilution.
• Formulation / handling – physiological buffering and resuspension.

mRNA

• Buffer exchange – working buffer for handling of intermediates.
• Dilution & handling – sample dilution and transfer.

Cell & gene therapy

• Cell washing & resuspension (cell products) – physiological wash of cells and vectors.
• Vector dilution – dilution of viral-vector intermediates.
• Final formulation – physiological base for the formulation.
• Fill-finish handling – dilution and handling to fill.

Frequently asked questions

Beyond compendial – on request. Like every PAN process liquid, GMP DPBS is also available in a beyond-compendial version produced with WFI Beyond – Water for Injection engineered beyond the Ph. Eur./USP monograph – for the most demanding endotoxin and purity requirements. Available on request.

Related: GMP-Grade Products overview · GMP DPBS – research grade (P04-36500)