Clinical OEM Solutions

You bring a vision. We’ll clear a path.

Developing and commercializing a regulated product requires more than just a transactional supplier; it takes a team that understands the entire journey from development to delivery. Our Clinical Custom and OEM Services combine in-house expertise, robust production capabilities, and dedicated support to help you move forward with confidence and clarity.

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Clinical Manufacturing Support that Stays One Step Ahead

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cGMP Manufacturing

Benefit from a Robust & Certified Quality System

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Submission-Ready Confidence

Access proven processes & expertise

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Embedded Collaboration

We serve as an integral part of your team


Promega anticipated the challenges of bringing a new product to market
before we had fully recognized them.

-Diagnostic Lab


Support Across Your Diagnostic Workflow

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Scalable chemistry built to suit. Choose from solution-based, silica-binding (solid or mobile phase), cellulose-binding, and ion exchange nucleic acid purification technologies.

Review Workflow Considerations

Check Out Our Purification Technology

Customize Your HT Workflow

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Flexible, reliable amplification tools to support your clinical diagnostic assay development, from cGMP manufactured components to master mixes and lyophilized beads.

Achieve Reproducible PCR Assays

Review Workflow Considerations

Explore Custom Lyophilized Solutions for Point-of-Care Assays

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From design and development to manufacturing quality IVD assays, we provide quality assay development service backed by rigorous QC, trusted reagents and technologies, and proven technical expertise.

Learn More about CADS

Choose an OEM Partner You Can Rely On

From Research to IVD

Navigating this transition requires a partner who understands the difference and can scale with you. We offer guidance and support throughout your product’s evolution.

Reliable Delivery

Your assay depends on consistent, on-time delivery of critical reagents. Our robust supply chain and manufacturing infrastructure help ensure you get what you need, when you need it without interruption.

See How Our Logistics Are Built to Deliver

End-to-End Support

Our partnerships are grounded in technical expertise, proven processes and a deep understanding of your product lifecycle. We don’t just supply reagents; we help you plan, build, and commercialize.

Create Your Custom Workflow: Getting Started

Learn About Our Custom Process

High Quality & Compliant

Our processes and documentation align with global compliance expectations to help reduce risk and build trust. We’re here to help you meet quality and regulatory standards with confidence.

Learn About Our Quality Management Systems

View ISO Certifications

Manufacturing Expertise

Whether you need small-batch flexibility or high-throughput scale, our clinical manufacturing capabilities adapt to your product’s stage and complexity, while maintaining quality and precision.

Tips for Selecting a Custom Collaborator

Review Our Manufacturing Facilities

Learn How We Expanded Lyophilization to Meet Tomorrow’s Demands

Custom/OEM Solutions

Ensure consistency and compliance with OEM solutions customized for clinical needs. We work with you to deliver optimized formulation, format, and packaging to fit your unique intended use.

Understand Form, Fit, Function

Explore Our Product Format & Packaging

Custom Manufacturing Process

Supporting You from Start to Scale

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Intended Use



Alignment of product requirements.

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Development Materials


Refine product form, fit, and function to intended use.

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Pilot Lot Materials



Small scale manufacture to verify product performance.

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Production Lots



Final product manufactured to scale under cGMP as applicable.

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Ongoing Support



Technical documentation, quality certifications, support materials.

Real Stories. Real Results.

Explore how one clinical team forged their path with us

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Readiness in Action

Our custom clinical manufacturing team supported LumiraDx in rapidly adapting their diagnostic platform during an unpredictable public health crisis

Read the Case Study


One of the reasons why we always [choose] Promega on anything that’s new that we’re doing [is] because they are one of the top tier companies.
- LumiraDx


Resources by Application

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Fill out the form below so we can talk about what’s getting in your way and how we can
help clear the path. A representative will reach out to you to identify next steps.

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