Welcome to the homepage for Clearance Services. Manufacturers of biologics, such as blood products, monoclonal antibodies, recombinant proteins, tissue derived products, and some medical devices are required to assess the ability of the manufacturing process to produce a product that is safe for use in humans.
BioReliance offers the following Clearance Services:
• Viral Clearance and Viral Safety
• Cleaning Validation/Sterilization Validation
• Prion Detection (TSE clearance)
• Column Re-Use
• DNA Clearance
• Microbial Clearance
BioReliance has conducted thousands of Clearance studies for clients around the globe. Our experience allows us to advise our clients on the most appropriate process steps to study in order to satisfy regulators.
Below you will find some detailed information about our Clearance Services to help you learn more as well as link to individual services.
1. Viral Clearance and Viral Safety - Viral clearance studies are designed to assess the effectiveness of individual steps in a manufacturing process to reduce (removing or inactivating) potential contaminant viruses. The data is used from a study to provide a quantitative estimate of the overall level of virus clearance obtained during the manufacturing process. For viral clearance studies, infectivity assays are the preferred method to determine the effectiveness of a process step in removing and/or inactivating infectious agents. Valuable additional data on the partitioning of viruses can be obtained by the use of a quantitative polymerase chain reaction (Q-PCR) assay.
For more detailed information see our virus clearance page.
2. Cleaning Validation (aka sterilization validation or GMP validation). GMP regulations state that manufacturers of finished pharmaceuticals must clean their facilities and equipment to ensure product safety. Small scale testing is used to evaluate the efficacy of sanitizers, sporicides, and disinfectants to determine efficacy under the worst case conditions of use using viral and microbial agents.
For more detailed information see our cleaning validation page.
3. Prion Detection and Transmissible Spongiform (TSE) Testing studies are required to demonstrate downstream processes safely inactivate prions from biologicals derived from animal systems. The TSE Western blot assay has been in routine use at BioReliance since 1997 and is becoming increasingly more important as the need for TSE safety assessments of biologics increases. This assay specifically detects the disease-associated prion protein, PrPSc (or PrP-res). Levels of PrPSc have been shown to correlate closely with levels of infectivity. The Western blot assay provides a rapid means of making a preliminary evaluation of the effectiveness of steps in the removal of TSE agents, and can reduce the need for more expensive, lengthy bioassays.
For more detailed information see our TSE/prion detection page.
4. Column Re-use Studies - Over time and repeated use, of chromatography columns may be become contaminated with viruses and other adventitious agents. BioReliance can perform column resin sanitization and column re-use studies to determine the potential for carryover of virus and microbial agents during multiple cycles of chromatography resins. In addition, we have extensive in-house data on the inactivation of a panel of viruses using different concentrations of the common cleaning reagent, sodium hydroxide.
Contact Us with your questions about column re-use studies.