Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP)
Process liquid / water · GMP catalogue product · 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 | Article 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.
Where this product is used
Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP) is used in the following PAN application processes:
- Monoclonal antibody – Capture Chromatography (Protein A Affinity), Drug Substance Formulation & Final Bulk, Hydrophobic Interaction Chromatography (HIC) – optional, Ion Exchange Chromatography (IEX: CEX + AEX), Size Exclusion Chromatography (SEC) – Polishing, Ultrafiltration / Diafiltration (UF/DF – Concentration & Buffer Exchange), Viral Inactivation (Low-pH Hold), Bioreactor Production (Fed-batch / Perfusion), Cell Bank Management & Thaw / Cryorecovery, Cell Expansion & Seed Train (CHO / HEK293 / Hybridoma), Harvest & Clarification, Screening & Selection (Hybridoma / Seed Train)
- Cell & gene therapy – Clarification / Filtration, Fill & Cryopreservation / Storage, Harvest & Lysis, QC / Analytics + Stability, Cell Bank Management & Thaw, Cell Collection / Isolation, Vector Production / Transfection (Gene Therapy)
- Vaccine production – Viral Harvesting & Clarification, Concentration / Buffer Exchange (UF-DF), Vaccine Formulation (excipients grade), Virus Infection / Transfection
- mRNA technology – Fill & Storage, LNP Manufacturing & Encapsulation, RNA Purification, Solvent Removal / TFF, DNase Digestion, In Vitro Transcription (IVT), Template DNA Preparation
Frequently asked questions
What grade is Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP)?
It is offered at GMP grade (article 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 "Where this product is used" above for the specific steps in each.
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