Empowering Your Path to Success in Gene-Modified Cell Therapy
Comprehensive support from discovery to commercialization
Aldevron is committed to being your trusted partner as you develop your gene-modified cell therapy. From early discovery research to clinical trials and commercial production, our comprehensive support ensures you have the highest quality plasmids tailored to your project's unique needs.
Our meticulous attention to detail and commitment to quality control ensures all materials meet the highest standards, facilitating successful downstream applications and paving the way for groundbreaking therapeutic advancements.
We provide comprehensive support for lentiviral plasmid systems, ensuring high-quality production and optimization tailored to your gene-modified cell therapy projects. By partnering with us, you can focus on your core mission of developing life-changing therapies while we handle the complexities of production and compliance.
Discovery and development of lentiviral plasmids
In the discovery stage, we support you with initial research and proof-of-concept studies, focusing on the design and development of lentiviral plasmids.
Our third-generation lentiviral systems maximize safety and efficiency by splitting viral components across multiple plasmids, reducing the risk of recombination. This meticulous design ensures high-quality lentiviral vectors for successful gene-modified cell therapy applications.
We provide top-tier DNA manufacturing services, producing high-quality plasmid DNA tailored to each project's unique needs. With our expertise in plasmid design, process development, and QC packages that align to cGMP standards for seamless transition to clinical studies, we facilitate successful downstream applications and groundbreaking therapeutic advancements.
Identify gene of interest
Experience producing more than 165,000 plasmid DNA lots from 0.1 mg to 10 g.
Construct design
Fully custom Lentiviral plasmids (gag/polp, vsvg, rev, and GOI) or catalog ALD-Lenti System with standard 3 packaging plasmids in stock, and expression cloning vectors. It is designed to balance availability, quality, performance, and reproducibility.
NanoplasmidTM DNA, small backbone constructs that demonstrate up to an 8-fold increase in plasmid yield.
Optimize & 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
Ensuring Success in Preclinical Gene Therapy Studies
High-quality plasmids and rigorous quality control for reliable results
During preclinical studies, your therapeutic gene and viral delivery undergo rigorous in vitro and in vivo testing. Reliable, high-quality plasmids are pivotal for these studies, ensuring accurate and reproducible results that enable efficient transition to the clinic and improving chances of success in human trials.
Our commitment to rigorous quality control ensures all materials meet the highest standards of quality and safety, including phase-appropriate quality grades like GMP-SourceTM and cGMP. This meticulous attention to detail ensures reproducibility, helping you refine your therapies and improving their chances of success in human trials.
With consistent support and reliable materials, Aldevron builds strong, collaborative relationships, enabling you to advance your gene therapy projects with confidence.
Phase-appropriate quality systems
25+ years of robust technology transfer/process optimization, process development, and cGMP production capabilities.
Scalable manufacturing, including small scale cGMP, to support transition from discovery to large feasibility testing.
Flexible, phase-appropriate quality grades with production of 11,000+ GMP-Source and cGMP batches.
Optimize safety and dosage
Our experience offers phase-appropriate materials (from <100 mg to 50+ grams) with comprehensive regulatory support, proven by our involvement in 15 commercial programs.
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).
Navigate early-phase regulatory support
Early-phase regulatory support, including Investigational New Drug (IND) filing and comprehensive guidance, ensures your products meet all necessary regulatory requirements.
By providing consistent support and reliable materials, Aldevron builds strong, collaborative relationships, enabling you to advance your gene therapy projects with confidence.
Comprehensive Support for Clinical and Commercial Gene Therapy
Enabling safety, compliance, and successful commercialization
Aldevon provides comprehensive support for clients taking viral vector gene modified cell therapies through clinical trials to commercialization. It begins with the assurance of cGMP-compliant lentiviral plasmid production, to ensure safety and regulatory compliance. As therapeutic development progresses, scalable manufacturing solutions ensure seamless transition from small-scale engineering batches to large-scale commercial quantities.
By partnering with Aldevron, you can focus on the core mission of developing groundbreaking gene therapies, while Aldevron handles the complexities of production and compliance.
Scalable to 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.
Gain regulatory approval
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.
Aldevron offers a comprehensive suite of high-quality products and services to support your program, from discovery to cGMP.