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?
Losing confidence in your current partner’s ability to deliver consistent batch-to-batch quality?
Struggling to find regulatory support to advance your program to the clinic?
Trying to find a manufacturing partner that can handle development through large-scale manufacturing?
Having difficulty transferring innovative ideas from the benchtop to the production floor?
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*.
- Manufactured at the Breakthrough** campus in Fargo, North Dakota
- Track record with GMP regulations (21CFR210 and 211) and documentation
- 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.