Advancing Your Protein Every Day

Custom Protein Manufacturing for Diagnostic or Therapeutic Applications

When it comes to protein manufacturing, projects are as unique as our client’s aspirations. The challenges, from construct design and process development through analytical testing and characterization are equally unique. Many contract manufacturing partners don’t understand the power of customization.

Aldevron offers a combination of capabilities to fulfill your specific requirements. Whether you need help with method and process development or want to tech transfer an existing process, Aldevron can help if you are:

Experiencing long queues, impacting your time to market?

The expanded Innovate campus has immediate capacity to support your protein manufacturing needs*.

Losing confidence in your current partner’s ability to deliver consistent batch-to-batch quality?

Aldevron has a proven track record, spanning more than a decade, of producing high-quality proteins. When consistency is critical Aldevron delivers.

Struggling to find regulatory support to advance your program to the clinic?

Aldevron has supported clients from research to GMP, helping to ensure regulatory compliance ~1,100 clinical trial over the past 25 years.

Trying to find a manufacturing partner that can handle development through large-scale manufacturing?

Aldevron can support small development batches through commercial supply. Plus, we have immediate capacity in our Innovate campus for research and diagnostic proteins*.

Having difficulty transferring innovative ideas from the benchtop to the production floor?

Aldevron's team has years of experience supporting clients with out-of-the-box solutions for their complex needs. We can design a robust manufacturing process starting with an electronic sequence.

Custom Proteins Mfg.

for Research & Diagnostics

QMS Certified to ISO13485:2016

(21CFR820)

Research and Diagnostic Mfg.

Innovate Campus, Madison, WI

cGMP Manufacturing Facility

Breakthrough Campus, Fargo, ND

cGMP Quality Systems

Fargo, ND

cGMP Manufacturing Capacity

Manufacturing sites

We have decades of experience handling small to large projects, ensuring quality, purity, and reliability in dedicated facilities with all the necessary controlled environments and the meticulous validation processes in place. We have immediate capacity at our newly expanded facility to get your project in now*.

Therapeutic Protein

ALD Breakthrough_9_5_21_Exteriors_5

Manufactured at the Breakthrough** campus in Fargo, North Dakota
Track record with GMP regulations (21CFR210 and 211) and documentation

Diagnostic Protein

ALD Madison_Exteriors__21

Manufactured at the Innovate campus in Madison, Wisconsin
QMS certified to ISO 13485:2016 (21CFR820)

**This manufacturing facility was visited by the Center for Biologics Evaluation & Research (CBER) in November 2021. CBER conducted a Pre-License Inspection (PLI) and a general GMP audit of Aldevron, LLC. No Form FDA 483 was issued, and the inspection was classified as no action indicated (NAI)

*Availability as of July 2023 for process development, tech transfer, and manufacturing for research and diagnostics at the Innovate campus. Subject to change without notice.

At Aldevron we are agile – right-sized, we can quickly respond to your needs.

Talk with our experts

Interested in working together or have questions about our products and services? Reach out to our team to learn more about what we offer and how to get started on your next project.

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