Blazar^® Rapid Virus Detection

Our proprietary Blazar^® platform is an advanced multiplex and degenerate PCR technology for adventitious and species-specific virus detection that is in line with current regulatory guidance. The Blazar^® platform is a targeted molecular method that provides accurate and highly sensitive viral detection in days. By amplifying multiple targets within a conserved region of the viral family genome, our clients can detect a broader range of viruses compared to traditional PCR methods.

• ✓ Fast – screen for viruses within days and release your batches faster
• ✓ Broad coverage – detect viral variants using degenerate primers
• ✓ Sensitive – validated sensitivity of 10 genomic copies, even in challenging matrices
• ✓ Small sample volume – conserve precious material
• ✓ Automated – minimize handling errors
• ✓ Digital assessment and reporting – traceable and accurate
• ✓ Enables continuous manufacturing – expedite biomanufacturing timelines

Related Product Literature

• Alternatives to in vivo assays for biosafety testing of biologics

  Here we examine the current in vivo methods and explore alternatives which can be employed today. We also propose that while the industry may be some years away from removing in vivo testing completely, a case can be made for removing animal use from well-characterized production systems such as CHO.

• Accelerating Bulk Harvest Testing using the Blazar^® CHO Animal Origin Free Virus Panel for Rapid Adventitious Virus Detection

  This white paper describes the Blazar^® CHO Animal Origin Free (AOF) panel for rapid adventitious virus detection, a degenerate PCR-based approach to broad virus screening. I

Applications of the Blazar^® platform

Blazar® Platform	Description	Related Services	Modality	Compliance level	Turnaround Time
Current State
Blazar® Rodent panel	Provides a suitable alternative to the in vivo MAP/HAP/RAP test typically used to characterize rodent cells for biologics manufacturing, allowing to reduce dependence on in vivo models for virus detection while meeting both corporate and regulatory imperatives to decrease animal use	Cell Banking, Cell Line Characterization, and Biorepository	Biologics (monoclonal antibodies and recombinant proteins)	GMP	14 days (compared with >35 days for the MAP/HAP/RAP assay)
Blazar® CHO AOF panel	Designed as a suitable replacement for the in vitro assay for CHO bulk harvest testing, providing rapid results with appropriate breadth of detection (plus variants) and sensitivity	Bulk Harvest Release Testing	Biologics (monoclonal antibodies and recombinant proteins)	GMP	12 days (compared with 35 days for the traditional in vitro assay)
Future State
Blazar® panel with Targeted NGS	Combines the breadth of detection of targeted next generation sequencing (NGS) with the speed and sensitivity of PCR methods	Cell Banking, Cell Line Characterization, and Biorepository   Bulk Harvest Release Testing   Drug Substance, Drug Product Release Testing, and Stability Testing	Biologics (monoclonal antibodies and recombinant proteins)   Cell & Gene Therapies	GMP

A multiplex approach that goes beyond single target virus detection

A: Degenerate primers broaden specificity
B: Nested PCR approach enhances sensitivity

The Blazar^® platform will enable next generation bioprocessing strategies – from process intensification, to connected processing, to fully continuous manufacturing – expediting biomanufacturing timelines thorough enhanced productivity. Used in combination with our BioContinuum™ Platform, the Blazar^® platform offers significant potential to revolutionize biologics production.

Maintain a competitive advantage by accelerating your biologics program with the Blazar^® platform for rapid virus detection.

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