Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP)
Process liquid / water · GMP (CT-991500)
Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP) – Water for Injection quality water for media, buffer and formulation preparation, filled from 10 ml tubes to 1000 L bags in an animal- and antibiotic-free facility. A beyond-compendial version, WFI Beyond, is available on request.
One GMP quality. Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP) is a GMP-grade catalogue product (CT-991500), manufactured or assured by PAN-Celltech and released against a defined quality-control panel on every lot.
Why
- WFI quality – for media, buffer and formulation preparation.
- Wide fill range – 10 ml tubes to 1000 L bags.
- Beyond compendial option – WFI Beyond on request.
Specification
| Composition | Water for Injection quality water |
| Form | Liquid |
| Facility | Animal- and antibiotic-free |
| Grade | GMP |
| Storage | 15-25 °C (room temperature) |
Ordering
| Grade | Art. No. | Pack size |
|---|---|---|
| GMP | CT-991500 | 500 ml |
Other pack sizes on request.
Beyond compendial – on request. Like every PAN process liquid, Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP) 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)
Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP) is used at the following process steps across the biologics platforms it supports:
Monoclonal antibodies
- Cell Bank Management & Thaw / Cryorecovery – Thaw buffer prep; supplement reconstitution; rinsing; Ph. Eur./USP.
- Screening & Selection (Hybridoma / Seed Train) – Supplement reconstitution; buffer preparation.
- CHO – Buffer and supplement preparation.
- HEK – Buffer and supplement preparation.
- Hybridoma – Buffer and supplement preparation.
- Bioreactor Production (Fed-batch / Perfusion) – Large-scale media preparation; Ph. Eur./USP.
- Harvest & Clarification – System flushing; buffer preparation for filtration.
- Capture Chromatography (Protein A Affinity) – All buffer preparation; Ph. Eur./USP.
- Viral Inactivation (Low-pH Hold) – Buffer dilution; system flushing.
- Ion Exchange Chromatography (IEX: CEX + AEX) – Buffer preparation at process scale (100s of litres per run).
- Hydrophobic Interaction Chromatography (HIC) – optional – Buffer dilution to process concentration.
- Size Exclusion Chromatography (SEC) – Polishing – Buffer preparation.
- Ultrafiltration / Diafiltration (UF/DF – Concentration & Buffer Exchange) – Diafiltration buffer preparation at production scale.
- Drug Substance Formulation & Final Bulk – Formulation buffer preparation; final concentration adjustment.
Cell & gene therapy
- Cell Bank Management & Thaw – Thaw / dilution buffer prep.
- Cell Collection & Isolation – Buffer preparation.
- Harvest & Wash (cells = product) – Buffer prep.
- Fill & Cryopreservation – Fill base.
Vaccines
- Cell Line Development & Maintenance – Water base for all buffers and media.
- Virus Infection / Transfection – Infection / dilution.
- Viral Harvesting & Clarification – Harvest / dilution.
- Concentration / Buffer Exchange (UF-DF) – Diafiltration.
- Vaccine Formulation (excipients grade) – Final formulation / diluent base.
Frequently asked questions
In which grade is Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP) available?
It is available as a GMP product (CT-991500).
Which processes is this product used in?
Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP) 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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