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. Download

LakePharma's Integrated Solutions for ASR Manufacturing presentation by clicking here.

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:

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

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