The risk of viral contamination is a feature common to all biotechnology products produced by processes that use cell lines and raw materials of animal origin. Such contamination could have serious clinical consequences, and worldwide regulatory bodies expect that the viral safety of these products be ensured.

Viral clearance studies are performed as one way of demonstrating viral safety. The studies are executed by intentionally adding or “spiking” large amounts of virus into the starting material for individual manufacturing steps and assessing the capacity of those steps to eliminate infectious virus from the product stream.

Spiking virus preparations are considered to be critical reagents in viral clearance studies. The Parenteral Drug Association recently issued Technical Report 47: Preparation of Virus Spikes Used for Viral Clearance Studies. The technical report emphasizes that the production of virus stocks must be well controlled and that the resulting stocks should be tested for identity, strength, and purity. The report highlights that the desired level of purity of the stock preparation used to challenge individual clearance steps is dependent upon the location of the step in the manufacturing purification process. Specifically, crude virus preparations are considered appropriate for challenging early steps in purification, whereas purified virus stocks are preferred for challenging later steps in the process.

Lancaster Laboratories provides numerous well characterized virus stocks for clearance studies. In addition to meeting PDA recommendations concerning identity, strength, and purity, several levels of purification are offered for the most commonly used viruses. All virus stocks are available at titers of ≥10⁷ pfu/mL. Infectivity assays are performed in real time, and qPCR assays are available for selected viruses. All assays offered are fully validated, meeting ICH Q2 requirements. Validated assays for the testing of large volumes are also available.

Profile

With more than 50 years of collective experience, Lancaster Laboratories’ Viral Clearance Management Team provides a comprehensive set of services for the validation of your manufacturing purification process. Services range from consulting and study design to study performance, data interpretation, and reporting. In addition, Lancaster Laboratories’ experts will continue to provide regulatory support for each study performed well after the study completion date.

Lancaster Laboratories’ facilities and services are CGMP-compliant with multiple, well-equipped, and controlled client-dedicated clearance suites, providing the capacity to accommodate client studies with minimal delay. Lancaster Laboratories offers several service models for the performance of viral clearance studies.

Level 1 — Basic Service: The client provides all materials and down-scale procedures and performs the study in Lancaster Laboratories’ viral clearance suites.

Level 2 — Enhanced Service: The client provides all materials and down-scale procedures and performs all column chromatography steps. Lancaster Laboratories personnel perform inactivation and virus removal filtration steps.

Level 3 — Full Service: The client provides all materials and down-scale procedures for transfer to Lancaster Laboratories personnel, who perform all clearance steps.

Level 4 — Turnkey Service: The client provides a description of the full-scale manufacturing process. Lancaster Laboratories personnel develop and validate the down-scale procedures and perform all clearance steps.

Lancaster Laboratories also offers timely and secure access to raw data for viral clearance studies via our online data access tool, LabAccess.com. Clients can view extensive project information such as submitted samples, analysts’ notebooks, approved test results, certificates of analysis, raw data packages, and invoices.

About the Author

Author Details
Jeri Ann Boose, PhD, is the director of biopharmaceutical services at Lancaster Laboratories, 2425 New Holland Pike, PO Box 12425, Lancaster, PA 17605-2425; 1-717-656-2300; [email protected]; http://www.lancasterlabs.com.