In today’s biomanufacturing environment, confirming that process intermediates are free from detectable adventitious virus presents challenges. Traditional in vitro and in vivo virus testing typically take several weeks to complete and frequently offer limited sensitivity and identification of specific contaminants. Additionally, regulatory and ethical imperatives to decrease the use of animal models has reinforced demand for a new approach to biosafety testing. Molecular testing technologies have been developed, offering speed to results with the sensitivity and specificity to meet the needs of today’s biomanufacturers.
The evolution of biomanufacturing towards process intensification and continuous manufacturing, coupled with the more diverse range of patient treatments being developed, are powerful drivers for this new approach to accelerated biosafety testing.
Molecular testing technologies for detecting viral contamination can often deliver results in a few days or a week, compared to up to and often beyond 35 days for more traditional bulk harvest lot release testing methods. Directed polymerase chain reaction (PCR) and next generation sequencing (NGS) technologies each have advantages: PCR offers speed and sensitivity, while NGS features a broad detection range. A new rapid molecular detection platform utilizing a highly multiplexed degenerate PCR approach combines the benefits of both traditional PCR and NGS: rapid results with coverage of more than 5,000 viral variants, expediting biomanufacturing timelines for enhanced productivity.
Regulatory bodies currently require extensive cell line characterization to confirm species origin and history, as well as identity, stability, and purity. Today there are many options for this level of cell line analysis, with newer molecular methodologies offering more rapid time to results, allowing developers to get to clinic faster.
Raw materials are a source of variability in biomanufacturing. Supplier transparency, coupled with comprehensive testing to fully characterize raw materials, as well as easy-to-access documentation, provide assurance that raw materials are fit for purpose.
Viral contamination is a constant challenge to all biopharmaceutical production processes, with emerging viruses a particular concern. Understanding the susceptibility of raw materials to these viral contaminants, and the capability of both classical and molecular testing methods to detect them, is an essential part of any viral safety strategy.
White paper: Rapid Biosafety testing enables the future of manufacturing
White Paper: Alternatives to In Vivo Assays for Biosafety Testing of Biologics
Medicine Maker Article: A Biosafety Revolution
Webinar: Rapid Methodologies for Biosafety Testing of Biologic Therapeutics
Webinar: Ending MAP/HAP: A Stepping Stone for Accelerating Cell Line Characterization
White Paper: Avoid Surprises With Comprehensive Cell Line Characterization
Webinar: Current Regulatory Expectations and Technical Advances in the Quality Control of Biological Medicinal Products
eBook: Viral Safety: a Global Regulatory Perspective
Webinar: Setting up for Successful Lot Release Testing
Article: Clearing Viral Concerns in Animal-derived Biomaterials
Article: Assuring Equivalency of Alternative Lot-release Test Methods
Webinar: Bioprocessing Raw Materials: Risk Mitigation Strategies
Webinar: Emerging Viral Risks and Mitigation Strategies in Biologics Manufacturing
Article: Schmallenberg Virus, an Emerging Viral Pathogen Detectable by Classical In Vitro Adventitious Virus Assay
Article: Mitigating the Risk of Zika Virus Contamination of Raw Materials and Cell Lines