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 batches sooner incorporating lab automation and digital reporting
• ✓ SENSITIVE - detect viruses, and any variants, down to as little as 10 genomic copies
• ✓ SAFE - fully validated and GMP compliant procedure

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 targeted molecular method for broad virus screening.

Applications of the Blazar^® platform

Blazar® Platform	Description	Related Services	Modality	Compliance level	Turnaround Time
Current State
Blazar® Rodent panel	A sustainable alternative to traditional in vivo MAP/HAP/RAP test. Reducing the use of animal models.	Cell Banking, Cell Line Characterization, and Biorepository	Biologics (monoclonal antibodies and recombinant proteins)	GMP	Conventional >35 days, now 14 days
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	Conventional 35 days, now 12 days
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
C: Fragment detection by capillary electrophoresis. Internal positive controls spiked into each test sample

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.

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

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