Innovation.
Quality.
Scale.
Proudly manufactured in the USA
MaximBio delivers integrated, U.S.-based development and manufacturing for immunoassay diagnostics—combining deep scientific expertise with proven operational scale to accelerate your path from concept to commercialization.
End-to-End Diagnostic Development & Manufacturing
Our integrated services enable excellence at every step of the diagnostics lifecycle - from early-stage assay development to full-scale production and fulfillment.
Assay Development
Antibody screening, selection, and conjugation
Custom reagent and buffer formulation
Product design, engineering, and system integration
Prototype and pilot-scale production
Prototyping, optimization, and pilot lots
Clinical and regulatory strategy support
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Manufacturing
Scalable production of lateral flow, ELISA, and custom immunoassays
Reagent formulation and dispensing
Device assembly and packaging
In-process and final quality control testing
Fulfillment, warehousing, and logistics
ISO-certified, environmentally controlled, FDA-registered U.S. facility
MaximBio Products
Developed and Manufactured in the USA
High-impact diagnostic tests addressing critical public health needs
Designed for accuracy, accessibility, and ease of use
Branded and private label solutions for retail, clinical, and government channels
Trusted partner to federal, state, and commercial healthcare programs
Manufacturing Excellence at Scale in the US
We’ve partnered with the world’s top healthcare companies and U.S. government agencies—including the DoD, CDC, and NIH—to develop and manufacture commercialized diagnostic products for our 20 years.
Serving the Fortune 100 & Innovative Diagnostic Startups
Maxim Biomedical supports its partners success with world-class IVD development and manufacturing expertise.
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Deep R&D Firepower
Scientific depth and innovation to solve the toughest assay development problems
End-to-end continuity
Seamless Development-to-Manufacturing execution under one roof
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Family-led values
Backed by personal commitment and accountability
Built to Serve Science and Scale
FDA-Registered Facility | ISO 13485:2016
ISO 5/7/8 Cleanrooms | Biochemistry & Dry Rooms
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World-Class Quality Infrastructure for Regulatory Success
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Scalable, Compliant Manufacturing for Regulated Markets
MaximBio is Trusted when Success is Required
Pandemic Response at Speed
From Concept to 22+ Million Tests Delivered for the U.S. Government
In response to the urgent national need during the COVID-19 pandemic, MaximBio partnered with the NIH RADx initiative and the Department of Defense to develop and deliver the ClearDetect® COVID-19 Antigen Home Test.
- Full Lifecycle Execution: MaximBio led the end-to-end development—spanning R&D, regulatory submission, and EUA approval—delivering a fully realized diagnostic product at unprecedented speed.
- High-Volume Manufacturing: Over 22 million tests were produced for U.S. government distribution, including 8 million tests in less than 4 months, demonstrating agile scale-up and manufacturing resilience.
- Proven Performance Under Pressure: This initiative highlighted MaximBio’s ability to mobilize quickly and meet complex regulatory, technical, and operational demands—delivering speed, scale, and quality when it mattered most.
Class III Diagnostics - Built for Trust, Backed by Quality
A 15+ Partnership Supporting a Global Industry Leader
For over 15 years, MaximBio has served as a trusted development and manufacturing partner for Class III, BLA-regulated diagnostic products - among the most complex and highly regulated in the diagnostics space.
- Regulatory & Quality Excellence: Supporting a partner with global scale and exacting standards, MaximBio has established and maintained robust FDA BLA-compliant systems, including end-to-end documentation control and quality infrastructure designed for the highest levels of regulatory scrutiny.
- Long-Term Reliability: We ensure consistent, high-quality manufacturing that supports global distribution of high-value diagnostics - where precision, compliance, and performance are critical.
- Built for Scale and Rigor: This long-standing partnership reflects MaximBio’s ability to meet the demands of a top-tier diagnostics program, from Technical Transfer through sustained, commercial-scale production.
Your Diagnostic Partner at Every Step
Whether you're just getting started or scaling up manufacturing, MaximBio works as a true extension of your team—bringing deep expertise, flexible support, and a shared commitment to helping you succeed.