Contract Manufacturing
From pilot batches to millions of units per month, MaximBio provides flexible, U.S. based manufacturing you can trust
Flexible, Full-Scale Manufacturing Tailored to Your Product
MaximBio offers end-to-end manufacturing capabilities for lateral flow and ELISA diagnostics. Whether you're seeking small-scale production for validation studies or preparing to serve global markets, our Rockville, MD facilities are designed to scale with you. Our capacity is over 15 million devices monthly—with FDA registration and ISO-certified processes.
Our facility features:
26K sq. ft. dedicated development & production space
Custom Reagents & Buffer Solutions
Product design and engineering
Assay formulation (LFA & ELISA)
Prototyping, optimization, and pilot lots
A Complete Suite of Manufacturing Services
MaximBio combines scientific expertise, quality systems, and operational excellence to deliver high-performance diagnostic manufacturing at any scale. From custom reagent prep to fully assembled devices, we support complex programs with flexibility, precision, and reliability.
We believe the strongest results come from lasting partnerships - which is why we invest in long-term collaboration, offering the stability and shared commitment needed to scale together.
IVD Manufacturing Capabilities
Custom Reagent and Buffer Formulation
Enzyme and Nanoparticle Conjugation
Lateral Flow Test Dispensing and Assembly
ELISA Plate Coating
Quality Control Testing for In-Process and Final Lot Release
Production Infrastructure
Production Infrastructure
Batch Manufacturing
Reel-to-Reel Dispensing and Lamination
Precision Cutting & Assembly
Aseptic Filling
Kitting, Packaging, and Distribution
Manufacturing Transfer
We specialize in the seamless transfer of diagnostic products into our facility—whether you're relocating production to the U.S., scaling up for commercial launch, or transitioning from development to manufacturing. Our experienced team ensures a smooth onboarding process with technical alignment, quality continuity, and speed to scale.
Manufacturing in a World-Class Regulatory Environment
FDA-Registered Facility | ISO 13485:2016
ISO 5/7/8 Cleanrooms | Biochemistry & Dry Rooms
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0 FDA observations in 9+ years (Class I, II, III)
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EUA, 510(k), and BLA-aligned production processes
Let’s Scale Together
Whether you're ready to launch, need to ramp up production, or are transferring manufacturing to the US to improve your supply chain resilience, our team is here to help. Partner with a US-based end-to-end manufacturer that is committed to enabling you to achieve your long-term goals.
