Viral clearance

Viral Clearance

Ensuring viral safety is a critical requirement in the development and manufacturing of biopharmaceutical products. At LivoGen Pharmed, we provide Viral Clearance Studies to evaluate and validate the effectiveness of manufacturing processes in removing or inactivating potential viral contaminants. Our studies are designed in accordance with GLP guidelines, supporting regulatory submissions and ensuring the highest standards of product safety.

Using scientifically validated study designs and state-of-the-art analytical methods, we assess the viral reduction capacity of key manufacturing steps, including low-pH treatment, solvent/detergent (S/D) treatment, nanofiltration, chromatography, precipitation, and virus-retentive filtration. Our experienced team delivers reliable, regulatory-compliant data that help biopharmaceutical manufacturers demonstrate process robustness, minimize viral contamination risks, and ensure the safety of biosimilar and recombinant therapeutic products.

Viral Clearance

Our Viral Clearance Services:

Viral Clearance Validation Studies

Virus Inactivation Studies

Virus Inactivation Studies

Virus Removal Studies

Virus Removal Studies

Low-pH Inactivation Validation

Low-pH Inactivation Validation

Solvent/Detergent (S/D) Validation

Solvent/Detergent (S/D) Validation

GLP Documentation & Regulatory Support

GLP Documentation & Regulatory Support

Nanofiltration Validation

Nanofiltration Validation

Chromatography Clearance Assessment

Chromatography Clearance Assessment

Virus Spike Studies

Virus Spike Studies

Log Reduction Value (LRV) Determination

Virus Spike Studies

Study Design & Protocol Development