Experts in Non-viral Vectors for Gene Therapy
Advance drug delivery with Aldevron’s high-quality non-viral vectors
From discovery to commercialization, non-viral gene therapy is a promising alternative to traditional viral methods for delivering therapeutic genes into target cells. This approach minimizes risks associated with viral vectors, such as immunogenicity and insertional mutagenesis, while offering versatile and efficient delivery options. Notable non-viral methods include transposon-based systems, lipid-based vectors, and direct transfer of plasmid DNA.
As non-viral gene therapy methods continue to evolve, they offer safer and more efficient alternatives for delivering therapeutic genes. These advancements hold significant potential for treating a wide range of genetic disorders and diseases.
Accelerate your non-viral breakthroughs with tailored plasmid DNA manufacturing
In the discovery stage, researchers embark on a journey to identify and design the therapeutic gene and delivery method. This crucial phase aims to ensure that both the therapeutic gene and delivery are meticulously crafted to be effective and safe in treating the target disease.
Aldevron supports the discovery phase of non-viral gene therapy by providing high-quality plasmid DNA manufacturing services tailored to the unique needs of each project. Their expertise in plasmid design, process development, and strict adherence to cGMP standards ensures the production of plasmids with the highest quality and yield. This excellence in manufacturing facilitates successful downstream applications, enabling researchers to advance their non-viral gene therapy projects with confidence and efficiency.
Identify gene of interest
Experience producing more than 165,000 plasmid DNA lots from 0.1mg to 10 g.
Validate target
Nanoplasmid™ DNA, small backbone constructs that demonstrate up to 8-fold increase in plasmid yield.
Custom plasmid DNA manufacturing to meet your specific needs.
LNP encapsulation with agnostic mixing technology.
Optimize and test
Plasmid preps in as little as 72 hours, US-produced.
QC options including over 20 assays specifically aligned to our GMP-Source and cGMP QC offerings intended to ensure a smooth transition to higher quality grade requirements.
With decades of experience, Aldevron can propel your gene therapy projects forward, paving the way for groundbreaking therapeutic advancements.
Scalable Non-viral Development for your Preclinical Research
High quality plasmids to accelerate preclinical success
In the preclinical phase, your therapeutic gene and viral vector undergo rigorous in vitro and in vivo testing. This phase is crucial for determining the optimal dosage, identifying side effects, and gathering comprehensive data. It often requires multiple manufacturing runs to support clinical trial design and regulatory approval. Therefore, reliable, high-quality plasmids are pivotal for these studies. Consistency in plasmid quality is essential to ensure accurate and reproducible results. Variability in plasmid yield and purity can hinder the progress of gene therapy development, leading to delays and increased costs.
Aldevron is there every step of the way, supplying high-quality plasmids for each production for your non-viral therapy. Our commitment to rigorous quality control ensures that all materials meet the highest standards of quality and safety. This meticulous attention to detail helps researchers gather accurate and reliable data, crucial for refining therapies and improving their chances of success in human trials. By providing consistent support and reliable materials, Aldevron builds strong, collaborative relationships with clients, enabling them to advance their gene therapy projects with confidence.
Phase-appropriate quality systems
Scalable manufacturing, including small scale cGMP manufacturing, to support transition from discovery to large feasibility testing.
Optimize safety and dosage
Our experience offers phase-appropriate materials (from <100mg to 50+ grams) with comprehensive regulatory support, proven by the support of 15 commercial programs.
Gain support from regulatory agencies
Early-phase regulatory support, including Investigational New Drug (IND) filing and
comprehensive guidance, ensures that your products meet all necessary regulatory
requirements.
Advanced facilities
State-of-the-art production facilities with experienced operators to meet rigorous standards, including an EMA certificate of GMP compliance (awarded by Upper Bavarian authorities) and multiple FDA inspections with no reported observations (Form 483).
By providing consistent support and reliable materials, Aldevron builds strong, collaborative relationships, enabling you to advance your gene therapy projects with confidence.
From clinical to commercial, without the complexity
Comprehensive cGMP solutions to simplify your path to market
Embarking on the journey of non-viral vector gene therapy development with Aldevron is a seamless and supportive experience. It starts with GMP-compliant production, ensuring that your vector plasmid meets the highest clinical trial standards. This provides clients with confidence in the quality and safety of their products. As the therapy progresses, clients benefit from scalable manufacturing solutions.
Aldevron's capability to transition from small-scale engineering batches to large-scale commercial quantities ensures that clients can smoothly scale up their production as needed, without any disruptions. By partnering with Aldevron, clients can focus on their core mission of developing groundbreaking gene therapies, while Aldevron manages the complexities of production and compliance. This makes the journey from clinical trials to market as smooth and successful as possible.
Scale up in cGMP
cGMP custom manufacturing of your plasmid DNA ensures meeting clinical trial deadline and commercialization standards.
Process characterization and PPQ
With Process Performance Qualification (PPQ), you can ensure that every step of your manufacturing process meets stringent quality criteria. PPQ validates the process from development to production, supporting the safety, efficacy, and scalability of your products.
Navigate early-phase regulatory support
Extensive experience working with regulatory agencies over 25+ years supporting thousands of clinical trials and 15 commercial products. Our team helps clients navigate complex regulations and prepare regulatory filings
By providing consistent support and reliable materials, Aldevron builds strong, collaborative relationships, enabling you to advance your gene therapy projects with confidence.
Expert CDMO services for non-viral vectors
We are leading the way in advancing non viral vector gene therapy programs from early stage development, through to clinical trials and commercialization.
With over 25 years of experience in plasmid DNA manufacturing, we've honed a specialized service model tailored to the unique needs of non-viral gene therapies.
Our flexible, scalable solutions address the most critical challenges in therapeutic development. We offer consistent quality, adherence to evolving regulatory standards, and the capacity and expertise to enable efficient scale up from the bench, to commercialization.