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.
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|
|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.