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.
Clinical Manufacturing Support that Stays One Step Ahead

cGMP Manufacturing
Benefit from a Robust & Certified Quality System

Submission-Ready Confidence
Access proven processes & expertise

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

Sample Purification
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

Sample Amplification
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

Clinical Assay Development Services (CADS)
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.
Choose an OEM Partner You Can Rely On
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.
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.
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.
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.
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
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.
Custom Manufacturing Process
Supporting You from Start to Scale

Intended Use
Alignment of product requirements.

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

Pilot Lot Materials
Small scale manufacture to verify product performance.

Production Lots
Final product manufactured to scale under cGMP as applicable.

Ongoing Support
Technical documentation, quality certifications, support materials.
Real Stories. Real Results.
Explore how one clinical team forged their path with us

Readiness in Action
Our custom clinical manufacturing team supported LumiraDx in rapidly adapting their diagnostic platform during an unpredictable public health crisis
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
eBook: Achieve Reproducible PCR Assays
Webinar: See Our Guidelines for Robust PCR Assays
Video: View PCR Optimization in Action
Technical Manual: Learn About Our PCR Optimization Kit
Application Note: See How Our PCR Optimization Kit Improves Performance
Application Note: Explore Guidelines for Evaluating PCR Performance
Application Note: Explore Guidelines for Validating Multiplex PCR
Request a Consult
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.