For 25 years Aldevron has been a catalyst, advancing therapeutic and vaccine development through expert plasmid DNA, RNA, and protein custom manufacturing, supporting our clients from discovery to commercialization. Our custom development and manufacturing (CDMO) services have given scientists around the world essential components to accelerate their research and make a difference.
Whether you’re working on a gene therapy, cell therapy, or vaccine development, 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.
Our current 75,000 square-foot, GMP manufacturing facility has been producing high quality plasmid DNA since opening in 2018, to help meet worldwide demand. Our 189,000 square-foot expansion features industry-leading innovations and significantly increases production. 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).
Aldevron is not just another CDMO. We are innovators, offering creative solutions to today’s challenges in delivering impactful cell and gene therapies or nucleic acid vaccines. For example, the Nanoplasmid™ vector platform is an alternative to antiquated pUC vectors. The Nanoplasmid bacterial region is <500 bps and eliminated antibiotic resistance selection resulting in better performing, safer plasmids for cell & gene therapy applications.
We offer both traditional plasmid DNA and Nanoplasmids at phase-specific quality grades from small-scale research to commercial-scale GMP grade. Our services have evolved with the industry, including GMP-Source® quality grade, a cost-effective and faster alternative to cGMP. Our cGMP service provides the higher quality oversight, process control, and can support any application.
RNA Drug Substance and Drug Product
Aldevron has been providing mRNA drug substance to our clients since 2018, having completed >70 batches of RNA in our GMP manufacturing suite. In May 2023 Aldevron announced an expansion of its mRNA production capabilities to include lipid nanoparticle (LNP) encapsulation and aseptic fill-finish capabilities, enabling mRNA cGMP manufacturing services from electronic sequence to full drug product. This new capability supports the production of therapeutic-scale clinical and commercial-stage mRNA therapies for cancers and genetic diseases, and clinical-stage vaccines for infectious diseases. Leveraging partner companies including Cytiva and Precision Nanosystems, Aldevron provides a complete solution for mRNA development within a single workflow and quality system. The new services will streamline, expedite, and simplify mRNA programs by reducing lead times, risks, and project overhead.
Aldevron’s SpyFi Cas9 High Fidelity Nuclease was the first nuclease available on the market as a GMP-manufactured catalog product. Having nucleases for sale at both research grade and GMP grade allows Aldevron to support clients from early-stage research through clinical trials and beyond without the added costs or adding to timelines for custom manufacturing.
To further support our gene editing clients, Aldevron offers a full RNP service solution* to streamline CRISPR reagents into therapies. Working with our client’s unique guide RNAs (gRNAs), we define the optimal conditions for complexing, characterizing, and storing CRISPR RNPs. Aldevron uses a variety of in-house methods to quantify the amount of complexed RNP, relative to uncomplexed, free-Cas9 and free-gRNA, during cGMP manufacturing. In addition, our proprietary release panels are compliant with 21CFR210-211 and designed to meet current draft guidance from the FDA regarding gene editing, which provides consistency of the final product.
Protein / Enzymes
Aldevron manufactures a wide variety of custom proteins including enzymes, growth factors, and nucleases. Like our other custom manufacturing services, we offer different levels of QA/QC and regulatory compliance, depending on our client’s individual needs. We produce proteins/enzymes for research, molecular diagnostics, and clinical applications. The Aldevron Innovate campus is ISO13485 certified and can produce proteins for diagnostics. Our Breakthrough campus is GMP certified for clinical applications. In all cases, Aldevron offers extensive experience with process development or transfer and analytical service.
It’s Aldevron’s mission to provide products and services that make meaningful contributions to cell and gene therapy. We seek to be the partner of choice with custom manufacturing and/or standardized, catalog products, such as CRISPR nucleases, that support of our clients’ comprehensive objectives.
*Aldevron provides RNPs only to customers who are duly licensed, including to make and have made RNPs, for their intended use.