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. LakePharma offers integrated solutions for ASR from discovery to GMP-manufacturing.LakePharma 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 LakePharma'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

To download LakePharma's Integrated Solutions for ASR Manufacturing presentation, click here.

To download discovering diagnostics with LakePharma's ASR solutions flyer, click here.