Analyte-Specific Reagent Manufacturing
Analyte-Specific Reagents (ASR) are defined as biological compounds that are utilized as diagnostic tools for the detection and quantification of individual compounds within a specimen.
Curia offers integrated solutions for ASR from discovery to GMP-manufacturing. Curia offers manufacturing services of ASRs in its ISO 9001:2015 certified facilities in the United States. Materials can be produced under two different grades:
- cGMP: Complete Quality Management System oversight and compliance, instrument IQ/OQ/PQ, raw material supplier verification, and batch record documentation.
- Bioprocessing Grade (BPG): Instrument IQ/PQ, raw material supplier verification, and batch record documentation
GMP production of antibodies & proteins for critical assays and diagnostic application – From Development to Manufacturing in 100 days Download Brochure
Both Curia’s TunaCHO™ and CHO-GSN™ expression platforms can be used in the development & manufacturing of ASRs:
TunaCHO™ transient development & manufacturing
- Quick turnaround time
- 1 L – 100 L production tailored for specific needs
CHO-GSN™ stable cell line development & manufacturing
- Robust, high performance
- Flexible production scale
Various customization options for the final product are available
- Concentration and fill/finish
- Release criteria
To download Curia’s Integrated Solutions for ASR Manufacturing presentation, click here.
To download discovering diagnostics with Curia’s ASR solutions flyer, click here.