Viral & TSE Clearance

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 Experience

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
gamma irradiation
heat treatment
lyophilization

 

Product Experience
monoclonal antibodies (mAB)
recombinant proteins
glycoproteins
plasma-derived products
vaccines
medical devices
cell therapy products
viral gene therapy products (AAV)
animal-derived products
novel therapies

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.

For more information about our levels of service and how we can help best accommodate your study needs please contact us at www.texcell.com | info@texcell.com

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.

For more information about our virus panel, visit the virus panel page or contact us at www.texcell.com | info@texcell.com