Viral & TSE Clearance

Viral Clearance / TSE Clearance Studies With Texcell

  • Executing GLP Viral Clearance  since 2002
  • Key personnel have combined >40 years of experience in Viral Clearance
  • > 2,500 Viral Clearance Evaluations at the Maryland Facility
  • > 8,000 Evaluations World Wide
  • All Viral Clearance studies executed under relevant regulatory guidance: FDA, USP & EMA
  • Experienced with Monoclonal Antibodies (mABs), Recombinant Proteins, Vaccines, Blood Derived Products, Medical Devices, Gene Therapy and Novel Therapies

Texcell – North America, Inc. (TXNA) is a Contract Testing Organization for Biological Safety located in Maryland, that is part of a world-wide company that offers cGMP cell banking & characterization, viral clearance, viral safety services and batch/lot release testing.

Our knowledgeable scientific staff has performed viral clearance  for a range of purification steps including chromatography, filtration, and inactivation methods as well as evaluations of column age and sanitization/cleaning efficacy.


Our Experience

Investigational Viral Clearance Studies

  • A for information only (FIO) Investigational study is a great way to evaluate a novel process step, optimize process conditions, and assess potential log reduction values (LRVs). They are a quick and cost-effective way to optimize and research a process step.

GLP Viral Clearance Studies

  • Studies executed under GLP regulatory guidance for submission of Phase I (IND) or Phase III (BLA/Marketing Authorization) with the FDA, USP 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
gamma irradiation
heat treatment


Product Experience
monoclonal antibodies (mAB)
recombinant proteins
plasma-derived products
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 |

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 |