Max Sellman, Product Manager
Driven by a mission to assist researchers and biologists to expedite research, Aldevron specializes in manufacturing high-quality, cost-effective biologics that meet their specific requirements. The company’s expertise includes custom and off-the-shelf plasmid DNA, mRNA, proteins, and enzymes delivered at research grade, GMP-Source®, and GMP grades.
“We deliver manufacturing proficiencies that combine unmatched scientific experience and industry knowledge with purpose-built facilities to help clients in each development phase—from concept to commercial production,” says Max Sellman, Product Manager at Aldevron.
Aldevron’s GMP-grade plasmid and recently acquired Nanoplasmid™ technology the preferred vector for genome editing supports a wide variety of applications including Adeno-associated Virus (AAV). The company bolsters mRNA-focused research with its high-quality mRNA produced using scalable and standardized processes capable of delivering milligrams to multi-gram quantities. Not stopping there, Aldevron excels in developing custom proteins, in vitro transcription (IVT) enzymes and CRISPR nucleases, including SpyFi™ Cas9 Nuclease, SpCas9, SaCas9, Cas12a, and associated variants for gene editing.
Clients can get many of these gene editing enzymes at either research grade or GMP grade from inventoried stock, to help facilitate the transition from research to clinical applications.
Apart from end-to-end production, Aldevron places cardinal value on product quality and has established a QC test panel for its catalog products. These quality control assays are performed on gene editing nucleases for release testing. The company’s cGMP production line aligns with FDA requirements, and it adheres to US 21 CFR part 211 requirements for GMP manufacturing. Aldevron has set up a regulatory affairs team to ensure regulatory compliance. In addition, the company has filed drug master files with the FDA for several catalog products, reducing the filing requirements for clients. Aldevorn’s industry expertise extends to providing expert support for regulatory filings to eventually translate those life-saving discoveries into commercial production.
Client onboarding at Aldevron begins with understanding their requirements and finding an essential match within the catalog products. This is ideal for customers as they have to purchase only for the quantity, they need rather than buying the entire batch. without any production process fee.
For companies opting for protein customization, Aldevron starts with a screening process. It ascertains the best growth conditions that yield the most optimum product for further (client’s side) downstream process. Aldevron then establishes workflows for purification, chromatography steps, and other fine details like buffer conditions. In addition, they develop assays for product quality validation. The company has in-house fermentation capabilities at various scales ideal for upstream production. After development, the processes are transferred to their GMP facility in Fargo, North Dakota, for biologics production and batch release.
We deliver manufacturing proficiencies that combine unmatched scientific experience and industry knowledge with purpose-built facilities to help clients in each development phase—from concept to commercial production
Aldevron holds many global partnerships to deliver highly efficient critical biologics for researchers. For instance, the company partnered with Integrated DNA Technologies (IDT) to develop the catalog product SpyFi Cas9 Nuclease. It is highly effective in reducing ‘off-target gene editing.’ Clients using SpCas9 only need a one-to-one substitution of SpyFi Cas9 to eliminate those effects. Aldevron collaborated with MaxCyte to demonstrate that the substitution can significantly reduce off-target edits and bring down background detection levels. The company has recently joined hands with Nature Technology Corporation and is offering extremely small backbone plasmids—for enhancing homology- directed pair (HDR) and gene editing—categorized under Nanoplasmid. Moreover, Aldevron is now part of the Danaher Corporation, a global science and technology innovator. This key partnership enables Aldevron to spin up collaborations and opportunities that could open doors for future innovations in gene editing.
Aldevron and Evanoa Sign Licensing Agreement
Friday, March 10, 2023
GAINESVILLE - Evanoa Bioscience Inc., a cell line developer for biologics manufacturing, together with Aldevron®, a global leader in the custom development and manufacture of plasmid DNA, RNA and proteins for the biotech industry, today announced the signing of a licensing agreement for two E. coli strains to be used in plasmid production.
Evanoa is using its proprietary evolution-based platform to develop novel strains of E. coli that produce more plasmid per cell and are more stable under fermentation conditions. Strains developed by Evanoa have been shown to produce as much as two times more plasmid per cell and total plasmid titer per fermentation. Based on these current favorable data, Aldevron has licensed the strains to further explore their utility in different environments.
“Evanoa’s platform is promising, and we are excited to explore the advantages of this technology for improved plasmid manufacturing,” said Venkata Indurthi, Chief Science Officer at Aldevron. “Aldevron is dedicated to innovation and looks forward to a successful partnership.”
These breakthroughs, particularly in plasmid yield per cell, promise to increase capacity, allowing more plasmid to be produced per fermenter run. While these results demonstrate significant production improvement for several plasmids via the Aldevron® AAV platform, Evanoa technology can be applied for the improvement of any type of plasmid.
“Plasmid production is an integral component of cost for exciting new therapies including vaccines, gene therapy products and other biologicals. Technology that significantly reduces the cost of plasmid production promises to increase availability of these life-saving drugs to more patients and improve the business sustainability of increasing research investment into expensive and important new treatments,” said Eudes de Crecy, CEO of Evanoa.
"Improving plasmid production in E. coli is a tough nut to crack from a genetic engineering standpoint, and there have been relatively few advances in the genetic understanding of plasmid copy number," said Tom Lyons, CSO of Evanoa. "The relative speed of development and magnitude of improvement Evanoa achieved with its evolution technology was quite remarkable. However,” Lyons added, “yields can be improved even further, so we are looking forward to expanding this partnership and support constant innovation at Aldevron® in service of their clients.”
Aldevron Announces Strategic Partnership with Acuitas Therapeutics
Monday, June 03, 2024
Collaboration expands Aldevron’s capabilities in mRNA lipid nanoparticle encapsulation
FARGO -Aldevron, a leading global manufacturer of DNA, RNA, and proteins used in cell and gene therapies and vaccine development, today announced it has entered a strategic partnership with Acuitas Therapeutics, Inc., a private biotechnology company specializing in the development of delivery systems for nucleic acid therapeutics based on lipid nanoparticles (LNPs). This partnership will allow Aldevron to expand its capabilities in mRNA LNP encapsulation by incorporating Acuitas’ proprietary LNP encapsulation platform, increasing Aldevron’s services and capabilities as an mRNA sequence-to-vial custom manufacturer.
In May of 2023, Aldevron announced the expansion of its mRNA production capabilities to include Cytiva’s mRNA LNP encapsulation and aseptic fill-finish platform. This new strategic partnership with Acuitas Therapeutics, working with its encapsulation platform, equips Aldevron with a diverse range of mRNA LNP technologies, significantly enhancing its mRNA end-to-end drug product service capabilities. The partnership will enable Aldevron to support Acuitas’ LNP formulations and licensees.
“This collaboration with Acuitas is an exciting addition to our existing mRNA sequence-to-vial services and will enable Acuitas partners to leverage Aldevron’s extensive mRNA manufacturing experience and comprehensive end-to-end capabilities,” said Mark Wetzel, Vice President mRNA CDMO at Aldevron. “We look forward to our continued partnership that is poised to enhance the landscape of mRNA-based therapies, bringing faster timelines and hope, to patients worldwide.”
“We have long known of Aldevron’s reputation and broad experience in the manufacturing of nucleic acids and their commitment to quality,” said Chris Barbosa, Vice President of Technology Development at Acuitas Therapeutics, Inc. “We are pleased to work with Aldevron to provide Acuitas partners with an integrated path to clinical drug products using Acuitas’ lipid nanoparticle manufacturing processes.” He added, “We look forward to Aldevron’s contribution to working with us to support our global partners in bringing new mRNA-based therapies to patients as quickly and efficiently as possible.”
“The Acuitas technology, combined with Aldevron’s extensive experience providing cutting-edge solutions for advancing therapies and rigorous quality processes, provides an exceptional advantage,” continued Wetzel. “With our two decades of experience in mRNA technologies, Aldevron has developed a seamless workflow from mRNA sequence-to-vial, and this partnership provides clients LNP platform flexibility for the appropriate development stage for their program.”
