Contract Development & Manufacturing (CDMO)

From Concept to Commercial Scale

Your Diagnostic Partner

Our Contract Development and Manufacturing Organization (CDMO) services provide comprehensive support for organizations seeking to develop custom lateral flow assays or scale existing prototypes to commercial production. We serve as an extension of your team, bringing specialized expertise in immunoassay development, manufacturing optimization, and quality systems.

The development process begins with feasibility assessment and technology selection. Our team evaluates your target analyte, clinical requirements, and market positioning to recommend optimal assay formats, antibody selection strategies, and conjugation approaches. We can source or develop monoclonal/polyclonal antibodies, optimize nanoparticle conjugation protocols, and design membrane systems for maximum sensitivity and specificity.

CDMO Services Include:

Scale-up and pilot manufacturing
Stability studies and batch release
Quality control (QC) and batch testing
Documentation support: IFUs, CoAs, validation dossiers
End-to-end custom LFA development

Ideal For

Biotechnology companies without in-house manufacturing capabilities, academic institutions commercializing research discoveries, pharmaceutical companies developing companion diagnostics, public health organizations requiring custom surveillance tools, and medical device companies expanding diagnostic portfolios.

Key Benefits:

Eliminates capital investment in specialized manufacturing infrastructure
Accelerates development timelines through access to experienced teams
Ensures compliance with quality standards
Provides scalable production from pilot batches to commercial volumes
Delivers complete documentation packages supporting regulatory submissions and customer requirements

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