Viral Clearance / TSE Clearance Studies With Texcell
Texcell offers investigational, for information only (FIO), and GLP-compliant viral clearance studies. Texcell has conducted over 7,600 viral clearance evaluations worldwide. Data generated by Texcell has been used to support regulatory filings submitted to various regulatory agencies, including the FDA and EMA.
Our knowledgeable scientific staff has performed viral clearance evaluations for a range of process steps and products.
|Process Step Experience|
|Inactivation||Chromatography||Virus Removal / Filtration|
|pH treatment||affinity||experience with all major viral filter vendors|
|solvent/ detergent||anion exchange||diafiltration|
|chemical treatment||cation exchange||chemical percipitation|
|heat treatment||mixed mode|
|E- Beam||hydrophobic interaction|
|monoclonal antibodies (mAB)|
|cell therapy products|
|viral gene therapy products (AAV)|
Levels of Service
We recognize that every client is unique, and to accommodate teams both big, and small, we offer a variety of different service packages that are designed to best meet your needs.
Level I: A Traditional Study
The client is responsible for the execution of the scaled down manufacturing process, while Texcell performs the virus spiking studies.
Level II: Added Assistance
Texcell provides staff to technically assist in the execution of the client’s scaled down manufacturing process and will perform the virus spiking studies.
Level III: Full Execution
The client will technically transfer their scaled-down manufacturing process. Texcell will provide staff to technically execute the clients scaled down manufacturing process and will perform the virus spiking studies.
What Viruses Should I Test?
Selecting your virus panel depends on the unique characteristics of your product. Accounting for raw material inputs and environmental variables are instrumental when selecting your virus panel. Through Texcell’s virus panel, you can find the viruses that best meet your testing needs.