Diagnostic Assay Development & Manufacturing
Transform your diagnostic concepts into market-ready solutions with Fortis Life Sciences. Our comprehensive development and manufacturing capabilities, backed by ISO 13485 certified and cGMP compliant facilities, accelerate your path from innovation to commercialization.
Core Development Services
Molecular Diagnostic Assay
Partner with our expert scientists to optimize and manufacture the molecular tools you need. Whether you're seeking to match existing enzyme performance, create custom master mix formulations, or develop specialized solutions for new instruments, we deliver reliable results at scale. Our vertically integrated approach and ISO 13485:2016 certified facility ensure consistent quality from development through commercial manufacturing.
Lateral Flow Assays
We specialize in process development and manufacturing ultra-sensitive quantitative diagnostic assays, guiding you from initial feasibility through commercial production. Our expertise spans multiple formats including competitive and sandwich assays for proteins, hormones, antibodies, and pathogens, supported by proprietary gold nanoshell technology for enhanced sensitivity.
Complementary Technologies
Lyophilization Services
Leverage our 25+ years of expertise in lyophilized bead technology to enhance reagent stability and eliminate cold chain requirements. Our facility can produce up to 60 million beads monthly, offering customizable sizes from 3µL to 40µL for various applications including PCR reagents, antibodies, and proteins.
Blood Separation Membranes
Our PrimeCare™ asymmetric membranes enable efficient blood component isolation with separation times up to 60s/cm². Available in multiple variants with customizable pore sizes, these membranes feature proprietary anti-hemolytic coating for optimal sample integrity in your diagnostic devices.
Control Swabs
Revolutionize your quality control process with our lyophilized control swabs that provide room temperature stability for extended periods of time. These precisely prepared controls deliver consistent dissolution and performance across lots, supporting applications from molecular diagnostics to rapid antigen detection.
