Leading the Way in Viral Gene Therapy
Top-tier manufacturing and regulatory expertise for groundbreaking advancements
Achieving success in viral gene therapy requires determination, innovation, and excellence. Each phase, from discovery to clinical and commercial production, demands meticulous attention to detail to ensure the safety, efficacy, and scalability of the therapeutic, the associated critical raw materials, and its delivery vector. With the right partner, these challenges become opportunities for growth and success.
Start your viral gene therapy journey early with Aldevron to ensure a seamless and supportive experience from discovery to clinical and commercial production. Throughout each stage, Aldevron's expertise and dedication to quality enable clients to advance their gene therapy projects with confidence and efficiency.
Powerhouse Plasmid Manufacturing for Discovery Research
Ensuring the safety and efficacy of viral vector components in the discovery phase involves thorough planning and meticulous testing. Balancing the need for innovation with regulatory compliance adds another layer of complexity.
Aldevron is your powerhouse partner in overcoming these challenges. Top-tier DNA manufacturing services and high-quality plasmid DNA production are tailored to meet your unique AAV plasmid production needs, with unmatched expertise in construct design, scale up requirements, and QC packages that align to cGMP standards for regulatory adherence down the line.
Identify gene of interest
Experience producing more than 165,000 plasmid DNA lots from 0.1 mg to 10 g.
Construct design
Begin with your own sequence for AAV plasmids (rep/cap, helper, and GOI) or use the catalog pALD-AAV System, which includes in-stock rep/cap, helper plasmids, and transgene cloning vectors. This approach ensures a balance of availability, quality performance, and reproducibility.
Nanoplasmid DNA, small backbone constructs that demonstrate up to an 8-fold increase in plasmid yield, while maintaining ITR-stability.
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.
High-quality plasmid manufacturing, right-sized for your program
During preclinical studies, your therapeutic gene and viral delivery system 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-Source TM and cGMP. This meticulous attention to detail ensures reproducibility, helping you refine your therapies and improving the chances of success in human trials.
Phase-appropriate quality systems
Scalable manufacturing, including GMP-Source and small scale cGMP, 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 robust quality overview and analytical packages.
Regulatory support
Early-phase regulatory support, including Investigational New Drug (IND) filing and comprehensive guidance, ensures that your products meet all necessary manufacturing 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.
Quality at Scale for Clinical and Commercial Supply
Reliable plasmid DNA for viral vector production to power your path to market
As you navigate late-phase clinical trials for your viral vector gene therapy, complexity increases. Ensuring your viral vectors meet stringent FDA standards for quality and safety is paramount. Scaling up production without compromising consistency and efficacy can be daunting. Additionally, gathering comprehensive data to demonstrate the therapy’s effectiveness and safety to regulatory bodies requires deep regulatory expertise and robust manufacturing processes.
Allow Aldevron to take on the production and compliance complexities, giving you access to scalable manufacturing solutions that transition smoothly from small-scale engineering batches to large-scale commercial quantities. This support enables you to focus on developing groundbreaking gene therapies, advancing with confidence through clinical trials towards regulatory approval.
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.
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.
Flexible solutions to accelerate your viral vector development
We’ve stood side-by-side with thousands of clients, leveraging over 25 years of experience in the cell and gene therapy industry to support their programs from discovery to clinic and commercialization.
Through this experience, we’ve developed and refined a tailored offering to address the unique challenges of developing gene therapies, tackling challenges such as scalability, quality requirements and regulatory aspects.
- AAV helper and packaging plasmids: https://www.aldevron.com/catalog-products/viral-vector-plasmids/pald-aav
- Lentivirus packaging plasmids: https://www.aldevron.com/catalog-products/viral-vector-plasmids/pald-lenti
- Small-scale cGMP services to support early-phase studies and rare indications in gene therapy: https://www.aldevron.com/tailored-viral-vector-solutions
- GMP-Source™ manufacturing: balance the needs of quality and cost in gene therapy development: https://www.aldevron.com/tailored-viral-vector-solutions
- High-quality plasmid preparation in as little as 72 hours – link to new RG plasmid landing page