Upstream & Downstream

Sodium chloride solution 0,9 %, GMP grade

Process liquid / buffer · RUO (P05-39500) · GMP (CT-39500)

RUO · P05-39500
GMP · CT-39500
Upstream · USP
Downstream · DSP

Sodium Chloride 0.9 % – a sterile isotonic saline for washing, dilution, system flushing and osmotic balance across cell-culture and downstream workflows.

Catalogue and GMP grade. Sodium chloride solution 0,9 % is a catalogue (RUO) product (P05-39500); a matched GMP grade (CT-39500) is also available. Both are manufactured or assured by PAN-Celltech and released against a defined quality-control panel on every lot.

Why

  • Isotonic saline – osmotic balance.
  • Versatile – wash, dilution, flushing.
  • Sterile – ready to use.

Specification

Composition 0.9 % sodium chloride
Form Solution
Grade RUO and GMP
Storage 15-25 °C (room temperature)

Ordering

Grade Article No. Pack size To Shop
RUO P05-39500 500 ml
GMP CT-39500 500 ml

Other pack sizes on request.

Beyond compendial – on request. Like every PAN process liquid, Sodium chloride solution 0,9 %, GMP grade can be prepared with WFI Beyond – Water for Injection engineered beyond the Ph. Eur./USP monograph – for the most demanding endotoxin and purity requirements. Available on request.

In the process – by application (upstream & downstream)

Sodium chloride solution 0,9 % is used at the following process steps across the biologics platforms it supports:

Monoclonal antibodies

  • Harvest & Clarification – Isotonic system flushing; simple wash and equilibration.
  • Capture Chromatography (Protein A Affinity) – Simple system flushing and equilibration wash.

Cell & gene therapy

  • Formulation – Physiological diluent. RUO: P05-39500.

Vaccines

  • Vaccine Formulation (excipients grade) – Physiological diluent for final formulation. RUO: P05-39500.

mRNA

  • Formulation (excipients grade) – Isotonic saline. RUO: P05-39500.

Frequently asked questions

In which grade is Sodium chloride solution 0,9 % available?

It is available as a RUO product (P05-39500); a matching GMP grade (CT-39500) is also available.

Which processes is this product used in?

Sodium chloride solution 0,9 %, GMP grade is used across the PAN Monoclonal antibody, Cell & gene therapy, Vaccine production and mRNA technology processes. See "In the process – by application (upstream & downstream)" above for the specific steps in each.

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