Case Study:
Comprehensive Pathway to Seamless Scale-Up of mRNA Drug Product Manufacturing
Case Study:
Enabling Novel CRISPR-Cas9 Delivery: Supporting Innovative Genomics Institue
Aldevron Breakthrough Blog
Work at Aldevron
Innovative Manufacturing Dedicated to Cell & Gene Therapy
Developing cell & gene therapies poses unique challenges, with complex manufacturing and regulatory landscapes. Since the beginning, Aldevron has supported these developments, putting our experience to work to help over 1,000 clients make their possibilities a reality. Today, 15 commercial cell and gene therapy programs rely on Aldevron products and services.
Advancing Modalities
Whether you’re working on a gene therapy, cell therapy, or vaccine, it starts with a high-quality DNA, RNA, or Protein. You’ll want a partner that can support you from small-scale, pre-clinical work through clinical trials, and eventually at commercial scale with phase-appropriate quality grades, analytics, and regulatory support.
Plasmid DNA Manufacturing
Nanoplasmid™ & Traditional plasmids. High-quality plasmid DNA for a wide range of research, preclinical, and clinical/commercial applications.
Nanoplasmid™ Design/Retrofit
The Power of Small: A next-generation backbone offering significant performance, safety, and manufacturing benefits.
mRNA Manufacturing & Encapsulation
High-quality, scalable mRNA manufacturing meeting a wide range of requirements from linear template through LNP formulation & encapsulation.
Protein/Enzyme Manufacturing
Gene-to-protein services, including custom protein/enzymes, and RNP complexes for research, manufacturing, diagnostics, and clinical applications.
Standardized Catalog Products
Standardization offers efficiency, cost savings, and may help alleviate supply chain concerns. In addition, many of our catalog products are license and royalty free* and available at research grade, GMP-Source™, and cGMP grade.
CRISPR Nucleases
High-fidelity and wild-type nucleases in-stock at research grade and cGMP to support research and clinical use.
In vitro Transcription & Capping Enzymes
Enzymes manufactured to support the journey from research through clinical trials and commercialization.
Viral Vector Plasmids
AAV & Lentiviral
Viral expression and helper plasmids that generate high-titer viral vectors for research and clinical production.
Cloning Backbones
Our inventory of empty vectors is royalty free and can be modified to fit your needs.
DNA/RNA Reporters
Various constructs that express fluorescent proteins for accessing transfection or to use as a control.
Advanced Facilities
When you start your research with us, you can travel one continuous path to finished product. We’ve designed and built facilities and capabilities to meet today’s needs, while continuing to build for tomorrow. Our most recent additions are LNP encapsulation, with our partners at Precision Nanosystems, and sterile fill finish capabilities to deliver drug product.
Certifications & Inspections
In June 2024, Aldevron received a Certificate of GMP Compliance of a Manufacturer from the competent authority of Germany for an inspection. The scope of the certificate is for mRNA as an active ingredient in the production of vaccines for clinical trials – Not Sterile.
The Breakthrough 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)
In July 2024, Aldevron’s Innovate Facility in Madison, WI received a renewal of its ISO 13485:2016 certification for development and manufacture of proteins for in vitro diagnostics and advanced proteins.
Breakthrough Campus
Fargo, ND
Plasmid DNA, RNA, Protein manufacturing at cGMP & GMP-SourceTM quality
Advance Campus
Fargo, ND
R&D, process development, manufacturing for early-stage research
Aldevron Madison
Madison, WI
R&D, process development, manufacturing for early-stage research
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About Aldevron
We provide high-quality plasmid DNA, proteins, enzymes, and other biologicals to help our partners achieve ground-breaking science throughout a variety of life science applications. From contract services to comprehensive solutions, we supply what you need, when you need it, with expert support at every stage of development and production.
Innovative Science. Consistent Biologics. Experienced Partner.
Contact us about our comprehensive development and manufacturing services and how we can help you navigate the pharmaceutical development cycle.
1 (701) 297-9256