To meet the diverse needs and capabilities of our clients, Texcell offers multiple options for viral clearance studies:
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). These studies are a quick and cost-effective way to optimize and research a specific process step.
GLP Viral Clearance Studies
- Studies executed under GLP regulatory guidance for submission of Phase I (IND) or Phase III (BLA) with the FDA, USP and EMA.
GMP Viral Clearance Studies
- Studies executed under GMP regulatory guidance meet the requirement for Market Approval with the Regulatory Agencies worldwide.
Our knowledgeable scientific staff has performed viral clearance evaluations for a range of unit operations and products.