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Aldevron & IDT Manufacture World’s First mRNA Based CRISPR Gene Editing Therapy
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Aldevron and Integrated DNA Technologies Manufacture
World’s First mRNA-based Personalized CRISPR Therapy
Aldevron and Integrated DNA Technologies (IDT) announce the successful manufacture of the world’s first personalized CRISPR gene editing drug product to treat an infant with urea cycle disorder (UCD).
• N of 1 therapy uniquely developed, on demand, for infant with life-threatening rare metabolic disorder in six months
• Results published in The New England Journal of Medicine and showcased at American Society of Gene & Cell Therapy Annual Meeting
Driving Therapeutic Progress from Discovery to Commercialization
Aldevron offers comprehensive manufacturing solutions and regulatory support, ensuring unparalleled quality and scalability for both viral and non-viral vector therapies. Our established custom manufacturing workflows and catalog products simplify the client journey from discovery through clinical trials to commercialization. Aldevron’s proficiency and dedication empower our partners in genomic medicine to advance their therapeutic projects with confidence, achieving groundbreaking success.
Gene Therapy
Unmatched expertise in plasmid design (both traditional and next-generation Nanoplasmid), process development, and QC designed to meet viral and non-viral gene therapy applications.
Gene-Modified Cell Therapy
Manufacturing of custom Lentiviral plasmids or use of the standardized ALD-Lenti System packaging plasmids designed to balance availability, quality, performance, and reproducibility.
Gene Editing
A full suite of high-quality products and services to support ex vivo and in vivo gene editing programs from discovery to clinical, including custom and catalog nucleases and gRNA (via IDT).
RNA Vaccines & Therapeutics
A complete service brings together RNA design, drug substance manufacturing, LNP encapsulation, fill/finish, and analytics all under one roof and quality system.
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.
Aldevron Basic Plasmid Preps
Aldevron Basic Plasmid preps include Maxi, Mega, and Giga preps; which are a great, cost-effective options for early discovery.
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