Contract Assay Development
Decades of expertise in lateral flow and immunoassay development
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The Trusted Partner for End-to-End IVD Development
End-to-end diagnostic development services, tailored to support every stage of your IVD journey with a focus on quality, scalability, and regulatory readiness. Backed by decades of experience, our team works collaboratively to design assays with manufacturability in mind—ensuring your product is built to perform, ready to scale, and set up for long-term success.
Feasibility & Prototyping
Rapid proof-of-concept development and early feasibility studies to de-risk programs and accelerate decision-making.
Chemistry & Reagent Design
Custom buffer systems, conjugates, and reagent formulations engineered for assay stability, performance, and compatibility with large-scale production.
Quality & Regulatory Readiness
Design controls, verification and validation studies, and documentation aligned with FDA and international standards—ensuring a smooth path from development to submission.
A Seamless Extension of Your Team
We act as a true extension of your team—owning critical workstreams while maintaining full transparency, clear communication, and strategic alignment.
Our Structured Development Process
MaximBio follows a proven, phase-gated development model designed to ensure scientific rigor, design for manufacturability, and regulatory alignment from day one. Each stage is purposefully structured to support efficient, scalable, and reliable commercialization.
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Development & Optimization
Designing for Performance and Scalability
Our scientists and engineers refine assay design, formulate reagents, and optimize conditions for accuracy, sensitivity, and robustness—always with manufacturability and regulatory expectations in mind.
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Verification & Validation
Data-Driven Validation You Can Trust
We conduct verification and validation studies aligned with FDA and international standards to confirm analytical performance, reproducibility, and lot-to-lot consistency—ensuring you're ready for submission and scale.
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Transfer to Manufacturing & Scale Up
Seamless Transition. Scalable Execution
Your assay is transferred into our in-house, FDA-registered, ISO 13485-certified facility—ensuring full control, quality, and scalability for pilot production, clinical trials, or commercial launch.
Broad Expertise Across Diagnostic Technologies and Formats
Our scientists and engineers bring deep experience across immunoassay platforms—including lateral flow, ELISA, and custom formats—tailoring each solution to the needs of the application
Visual & Fluorescent Labels
Single & Multiplex Assays
Reader and Non-Reader Platforms
Cassette & Dipstick Formats
Qualitative & Quantitative Assays
Competitive & Sandwich Formats
Diverse Sample Types
Single & Multiplex Assays
How We Helped Bring a Novel Women’s Health Test to Market
When a diagnostics partner faced a roadblock with a high-priority women’s health lateral flow assay, they turned to MaximBio to overcome the technical and regulatory challenges their previous developer couldn’t resolve.
- Advanced R&D Capabilities: MaximBio’s team solved key assay development hurdles, integrated novel detection techniques, and successfully guided the product through verification, validation, and regulatory clearance.
- Seamless Tech Transfer & Scale-Up: Following successful development, we transitioned the assay into routine commercial manufacturing, supporting stable supply and consistent product performance.
- Proven Long-Term Value: More than a decade later, the product has grown to become a market leader - demonstrating MaximBio’s ability to deliver sustained technical, regulatory, and manufacturing success for differentiated diagnostics.
Let’s Start Your Development Journey
We’re here to help you solve tough problems and accelerate your path to market. Whether you’re early-stage or preparing to scale, our integrated development and manufacturing teams work together to bring your diagnostic to life.