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:

  1. cGMP: Complete Quality Management System oversight and compliance, instrument IQ/OQ/PQ, raw material supplier verification, and batch record documentation.
  2. Bioprocessing Grade (BPG): Instrument IQ/PQ, raw material supplier verification, and batch record documentation

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
  • Quantity

TunaCHO℠ platform for transient protein & antibody production

Integrated Solutions for ASR Manufacturing at Curia

Curia can manufacture components of in vitro diagnostic kits for ASR or companion diagnostic applications under GMP conditions.

Ready to move from idea to impact?