Blaze Through Your Testing Bottleneck
Rapid Methods for Bulk Harvest Testing
Accelerate CHO Unprocessed Bulk Harvest Testing Using Rapid Methods for Biosafety Testing
Cell-based assays for adventitious virus testing of Chinese Hamster Ovary (CHO)-based unprocessed bulk harvest (UPBH) material can be time-consuming and create bottlenecks in downstream processing.
Discover the rapid methods package featuring the Blazar® CHO AOF panel and streamline your biologics (mAbs, recombinant proteins, vaccines…) testing process.
Designed for developers and manufacturers of mAbs or recombinant proteins utilizing CHO-based animal origin-free (AOF) manufacturing processes, this package is a suitable replacement or supplement to the traditional package thanks to:
- Faster results: 14 days vs. 35 days*
- Equivalent or better sensitivity*
- Established technologies, familiar to regulators.
- The use of molecular methods such as the Blazar® platform is in line with the evolving regulatory landscape (such as the ICH Q5A(R2) document)
- Reduced sample volume requirements*
- Fully validated and equivalent limit of detection to in vitro detection shown
* Compared to traditional methods
Shorter timelines, sensitive detection, and reduced sample volume requirements
The Rapid Methods package is suitable for use with bulk harvest test samples derived from CHO cells. The production process must be AOF and the cell banks (including master cell banks (MCB) and working cell banks (WCB), plus end-of-production cells (EOPC) where available) must be fully characterized through broad spectrum and species-specific virus testing.
The Blazar® CHO AOF Panel is the latest addition to our unique Blazar® Platform
The proprietary Blazar® CHO AOF Panel is a targeted molecular method designed to detect the presence of nucleic acid sequences specific to a panel of adventitious viruses. Virus families for the panel have been selected for their relevance to bulk harvest samples derived from CHO cell lines using AOF media.
Designed for developers and manufacturers using CHO cells to produce mAbs or recombinant proteins, the Blazar® CHO AOF Panel is a suitable replacement to the in vitro bulk harvest release test for adventitious viruses. As with all new methods, early discussion with regulators is recommended prior to implementation. Our expert regulatory consultancy team is available to help.
All assays in the Rapid Methods package are GMP-compliant and offered at multiple locations in our state-of-the-art testing network.
Related Resources
- Reference Guide: Accelerating Bulk Harvest Release Testing
Discover a Complete Set of Rapid Methods for Adventitious Agent Detection
- White Paper: Assessing the Blazar® CHO AOF Assay Against Traditional In Vitro Testing for Adventitious Virus Detection
This white paper help inform developers and manufacturers about the adoption of this rapid alternative method.
- Webinar: Full Speed Ahead: Accelerating Your CHO Bulk Harvest Testing Using Rapid Methods
Thanks to a package of innovative alternate methods, delivering both speed and sensitivity, we can accelerate your bulk harvest testing, detecting adventitious viruses in half the time of traditional methods.
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