Contract Development
& Manufacturing
Accelerate Your
Diagnostic Innovation
with a Proven Partner
Need help bringing a new diagnostic solution to life?
Biomerica is a trusted Contract Development and Manufacturing Organization (CDMO) with over four decades of experience specializing in lateral flow, point-of-care diagnostics, ELISA and Multiplex ELISA. We offer flexible engagement models—whether you need support for a specific development phase or an end-to-end solution from concept through scaled manufacturing. Our team works closely with yours to reduce development timelines, streamline production, and deliver reliable, high-quality diagnostic products.
OUR expertise
Why Partner With Biomerica?
- Decades of experience in IVD assay development, manufacturing, and regulatory support in FDA, CE, ISO and IVDR registered manufacturing facilities.
- Proven expertise in lateral flow, point-of-care diagnostics, ELISA and Multiplex ELISA design and production
- Scalable manufacturing with automated systems and custom lyophilization
- Trusted by global pharmaceutical and diagnostic companies
- Robust global sourcing for critical raw materials
- Seamless technology transfer and production scale-up
Our products are designed to enhance the health and
well-being of people, while reducing total healthcare costs.
50,000,000
Lateral Flow Tests
Manufactured
148,000,000
ELISA Wells Coated
21,000,000
Bottles Filled
Our CAPABILITIES
Assay Development & Custom Solutions
01
Custom Lateral Flow assay (LFA) development
We develop rapid lateral flow assays from concept, regulatory compliance and manufacturing. Our team specializes in point-of-care in vitro medical devices for various clinical indications using sample specimens including saliva, stool, tears, serum and blood ensuring your products meet stringent performance requirements for professional and at-home-use diagnostics.
02
Recombinant Antibody Development
With our advanced technologies, we develop high-quality
recombinant antibodies and establish stable cell lines
within just weeks. Offering both prokaryotic and
eukaryotic expression systems, we ensure reliable
performance, batch-to-batch consistency, and cost-
effective solutions tailored to your needs.
03
Custom ELISA and Multiplex ELISA assay development
With 30+ years developing IVD products, we create
high-performance ELISA and multiplex assays for
multinational diagnostic and pharmaceutical companies.
Our expertise covers creations of concepts, assay
development & verification, validation, optimization and
scale-up production, delivering reliable diagnostic
solutions that meet regulatory standards for in vitro
diagnostic use.
04
96-well plate coating (single and multiplex formats)
Supporting IVD manufacturers worldwide, we provide
precision coating services for diagnostic microplates.
Our cGMP-compliant facility ensures consistent, high-
quality coating of capture antibodies and antigens for
all indications, with full QC documentation for
regulatory submissions.
Meet With Our Experts
Our SERVICES
Your Single-Source Partner For Innovation & Scale
Biomerica offers integrated contract development and manufacturing services. Whether launching a new product or
improving an existing one, we help diagnostic innovators bring solutions to market faster—with precision and reliability.
Antibody & Reagent Services
Expert conjugation of antibodies to colloidal gold nanoparticles for use in lateral flow immunoassays and other rapid diagnostic applications. Our optimized protocols ensure consistent particle size distribution, stable conjugation chemistry, and maintained functionality for reliable test performance.
Precise horseradish peroxidase (HRP) conjugation services for ELISA and other enzyme-linked immunoassays. We deliver conjugates with optimal signal-to-noise ratios.
Strategic biotin labeling of antibodies using controlled conjugation ratios to maintain binding affinity while enabling versatile detection strategies. Our biotinylation services support streptavidin-based assay formats with consistent biotin incorporation and preserved immunoreactivity.
Manufacturing & Assembly Services in
our Mexicali FDA Registered Facility
Complete lateral flow device assembly from membrane preparation through final cassette construction. We provide cutting, and housing assembly services with stringent quality controls to ensure consistent fluid flow, proper reagent placement, and reliable test performance.
High-precision automated filling services for liquid reagents with integrated labeling and torque-verified capping systems. Our equipment ensures accurate fill volumes, proper seal integrity, and compliant labeling for both small-scale and commercial production runs.
Specialized freeze-drying services tailored to preserve biological activity and extend product shelf life. Our custom lyophilization protocols are optimized, and for capacity up to 2,000 vials per cycle and comprehensive stability monitoring.
Precision coating services for ELISA plates ensuring uniform antigen or antibody distribution across all wells. Our validated coating protocols deliver consistent density, minimal edge effects, and optimal binding kinetics for reliable assay performance.
Supply Chain & Technical Transfer
Comprehensive raw material procurement and qualification services to ensure supply chain reliability and product consistency. We identify qualified suppliers, establish testing protocols, and maintain approved vendor lists to support uninterrupted manufacturing operations.
Complete technology transfer services from initial process documentation through successful manufacturing implementation. Our team provides analytical method validation, process optimization, regulatory documentation support, and staff training to ensure seamless transition to commercial production.
End-to-end companion diagnostic development services from biomarker validation through regulatory supports. We provide assay design, clinical validation support, manufacturing process development, and regulatory strategy consulting to bring personalized medicine solutions to market.