Virus Clearance Validation Services - Confidence®
The Quicker Path to Your LRV Results.
Virus clearance studies are an essential step to get a biologic to the market. The goal of such studies is to verify how well a particular purification procedure removes or inactivates viral contamination.
When they’re poorly designed, however, they can lead to low log reduction values (LRV) — and questions from regulators. Confidence® Validation Services from Sartorius provide GLP virus clearance studies for any purification technology, as well as expert consultation.
Sartorius has readily available slots and optimizes project management to complete studies rapidly, with 9-week turnaround times for a typical GLP phase I study.
To achieve the highest possible log reduction values, we use highly purified viruses for all purification and inactivation steps.
The Sartorius team brings more than 50 years of experience and 700 completed projects to every virus clearance study.
Sartorius performs virus clearance studies remotely at no extra cost, eliminating the need to travel to the spiking facilities.
With Sartorius, biopharma customers get everything under one roof, including virus clearance consumables and validation services.
The Fundamentals of Virus Clearance Studies
In this video, you will learn more about the basic principles of virus clearance studies. In addition, we introduce you to the most important aspects of conducting these studies at Sartorius and give you more details about our virus clearance service offering.
Why Are Virus Clearance Studies So Important?
Every virus safety strategy is based on three pillars: selection of appropriate raw materials, testing of intermediate samples during production and removal/inactivation of viral contaminants. The latter is validated through virus clearance studies, which are an essential part of a manufacturer’s strategy to ensure product safety. Especially against adventitious viruses.
Failed Virus Clearance Poses Significant Risk to Patient Safety
The ultimate goal of virus clearance is patient safety. Consequences of Viral contamination can, in the worst–case cause harm to the patient’s health or cause drug shortage. The table below shows information about frequency and occurrence of viral contamination.
Source: Nature Biotechnology, 2020 “Viral contamination in biologic manufacture and implications for emerging therapies”. https://doi.org/10.1038/s41587-020-0507-2
Virus Clearance Validation is a Regulatory Requirement
Virus clearance is a regulatory requirement to ensure patient safety. To demonstrate that a manufacturer’s purification processes can deal with the unexpected, regulatory bodies implement the three basics of virus safety: Selection, Testing and Reduction.
FDA:
“Retrovirus clearance studies should be performed prior to Phase 1 trials”
“Clearance studies for other viruses and/or other contaminants should be carried out prior to production for Phase 2/3 trials and may need to be repeated if the final manufacturing process has changed. “
Source: Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, 1997 (FDA-1994-D-0318)
ICH Q5A:
“Careful design of viral clearance studies using different methods (orthogonal) of virus inactivation or removal in the same production process in order to achieve maximum viral clearance”
“Viral clearance evaluation studies are performed to demonstrate the clearance of a virus known to be present in the MCB and/or to provide some level of assurance that adventitious viruses which could not be detected, or might gain access to the production process, would be cleared.”
Source: Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, 1997
EMEA/CHMP/BWP:
“prior to Phase I studies, ...,, the process should be evaluated for the inactivation/removal of an enveloped virus and a small non-enveloped virus, unless otherwise justified. Two orthogonal steps should be assessed, if possible.”
“Whenever significant changes... in the manufacturing process are made... additional virus studies may be needed.”
Source: Guideline On Virus Safety Evaluation Of Biotechnological Investigational Medicinal Products, 2008 EMEA/CHMP/BWP/398498/2005 (2008)
How Reduction is Done: Exemplary mAb Purification Process
Virus clearance approaches for the biopharmaceutical industry require individual, scalable and flexible process solutions based on different technology platforms. Sartorius’ unique and orthogonal virus clearance technologies features virus removal by virus retentive filtration and membrane chromatography, as well as low pH virus inactivation.
How We Help You to Succeed
The Confidence® Virus Clearance Services Packages
Sartorius' expertise spans both virus clearance services and our specific clearance technologies, making it possible to provide a holistic solution to the customer. Our services are commonly combined with Sartorius' Virosart® virus filters, Sartobind® membrane adsorbers and CIM® monoliths, though products from other suppliers or other technologies, such as resins and low pH, can also be offered.
GLP Virus Clearance Studies
GLP virus clearance studies are regulatory required for investigational new drug (IND) submissions and before biologics license application (BLA). The studies will examine the ability of the biopharmaceutical manufacturing process to successfully remove or inactivate viruses.
Feasibility Studies
Confidence® feasibility studies can be used to thoroughly investigate problems, such as filter fouling and low LRV results, in an existing process. Conducting a feasibility study prior to GLP virus clearance studies ensures good results in a GLP study and prevents delays in product development.
In addition, feasibility studies are a good preparation for any GLP virus clearance studies to ensure good results and prevent delays in product development.
