Virus Clearance Testing

Any biopharmaceutical product that involves the use of animal-derived materials during the manufacturing process has the potential to be contaminated with animal viruses. Viral clearance studies are an important preventive measure to ensure the safety of these biologics and are an essential step in the marketing of biologics. CD Formulation provides fully cGMP-compliant viral clearance testing services from protein/peptide biopharmaceutical R&D evaluation to manufacturing and pre-market biologics license application (BLA) submission.

Purpose of Viral Clearance Studies

Virus clearance (VC) studies, as an important component of quality control during the manufacturing process, are mandatory for biopharmaceuticals that are obtained from human and/or animal sources, such as cell line-derived recombinant proteins, blood products, vaccines, and critical medical devices. The purpose of such studies is to verify how well a specific purification procedure removes or inactivates viral contamination.

Explore Our Virus Clearance Testing Services for Protein & Peptide Biologics

CD Formulation is an expert in viral clearance studies, providing GLP and non-GLP viral clearance studies, including consultation on viral clearance study design, implementation, and validation. Our services range from R&D assessment to manufacturing, clinical trials, and biologics license application (BLA).

Our scientists have decades of accumulated rich experience in viral clearance studies and have various expertise in research, process development, and manufacturing. This broad background as well as professional hands-on experience in executing and complying with regulatory requirements (e.g., ICH, FDA, and EMA) enables us to assist in the design, execution, and reporting of high-quality viral clearance studies.

To ensure the safety of these protein/peptide therapeutic products,

• Our scientists perform extensive testing on starting materials (e.g., cell banks) and raw materials used in manufacturing.
• We also conduct additional testing on the final product, at various stages of production as well as in some cases.
• Due to the inherent limitations of direct testing methods, our scientists will help you investigate the ability of downstream purification processes to remove/inactivate potential viral contaminants to further ensure that the final product is free of infectious viruses.

Our scientists design and conduct viral clearance studies to meet regulatory requirements. Our viral clearance services include:

• Viral clearance performance risk assessment.
• Design of viral clearance experiments for novel manufacturing processes.
• Design of viral clearance studies for early and late regulatory submissions
• Maximizing viral clearance efficiency in manufacturing processes to inactivate or eliminate viruses.
• Prepare viral safety assessments for your regulatory submissions.

Key Factors Considered in Our Viral Clearance Studies

The main risk of viral contamination for protein/peptide biopharmaceuticals is related to the cell culture process and exposure to the environment during the manufacturing process. To ensure the safety of biopharmaceutical products, the ability of the product production and purification process to inactivate and/or remove viruses needs to be studied by using several model viruses. Through these studies, it can be ensured that pathogenic microorganisms introduced from raw materials used in product production or materials used in the production process will not contaminate the purified product. When planning viral clearance studies, our researchers fully consider the following factors to ensure the effective implementation and validation of viral clearance testing.

Fig. 1 Key considered factors for viral clearance studies. (CD Formulation)

Process Step Selection for Viral Clearance

• Steps used to inactivate or remove viruses, such as low pH, solvents/detergents, pasteurization, terminal dry heat, radiation, and high-energy light.
• Steps that aid in viral removal, such as chromatography steps dedicated to purifying protein/peptide biologics and nanofiltration processes.

Selection of Viral Clearance Detection Technologies

• Infectivity (e.g. TCID50) detection.
• qPCR detection.

Selection of Indicator Viruses

• Lipid-enveloped viruses and non-lipid-enveloped viruses.
• DNA viruses and RNA viruses.
• Large particle viruses and small particle viruses.
• Viruses with the same or similar potential contamination risk.
• Viruses with strong resistance to the selected inactivation/removal method.

General Steps for Our Viral Clearance Studies

• Viral safety risk assessment of proteins/biologics.
• Selection of model viruses to test viral clearance.
• Selection of viral clearance process steps to evaluate.
• Narrowing down selected manufacturing steps.
• Preliminary studies of cytotoxicity and viral interference.
• Viral injection process runs.
• Process sample collection and titration testing.
• Data generation and viral clearance calculations.
• Report.

Our Expertise

Ensuring successful viral clearance is a critical aspect of developing and deploying protein/peptide biopharmaceutical products safely, effectively, and efficiently. Our ICH Q2-compliant viral clearance validation services provide best-in-class expertise to help you achieve your safety and regulatory goals and minimize the risk of viral contamination in your products.

Our experienced virology team develops custom study designs to address viral contamination validation at all critical stages of the protein/peptide biopharmaceutical manufacturing process, from the initial establishment of cell lines to the final product purification steps.

Our expertise covers：

• A wide range of validated and well-characterized viral libraries to support animal and human-derived biologics.
• Validated qPCR assays.
• Infectivity (e.g. TCID50) assays performed in real-time.
• Viral clearance efficacy and cleaning validation.
• Ongoing regulatory support after completion of viral clearance studies.
• Protein/peptide manufacturing process validation.

Our Technology Platforms

Why Choose Us for Virus Clearance Testing？

• We have a team of highly skilled and experienced professionals who have the expertise and skills to effectively conduct viral clearance testing in accordance with industry standards and regulations.
• Our scientists communicate with you regularly to ensure compliance with your process details while developing an achievable report release timeline.
• We adhere to strict regulatory guidelines and protocols to ensure that our viral clearance testing meets all regulatory requirements and standards.
• We have a strong track record in conducting viral clearance studies and reporting results to support investigational new drug (IND) and BLA applications.
• We offer flexible trial designs and customized solutions.

Publication

CD Formulation applies expertise in viral clearance studies to validate your protein/peptide biopharmaceutical process to help you ensure that your manufacturing process does not compromise product quality, efficacy, or safety. Please feel free to contact us if you are interested in our services or have further questions. We look forward to working with you.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.