Gene Therapy Process Development & Manufacturing Support Services
We can help you accelerate your gene therapy development while reducing costs and ensuring patient safety. Our gene therapy process development and analytical methods support helps you overcome development challenges and meet regulatory requirements faster. We integrate QC-centric method development with comprehensive analytical testing to streamline your path from discovery to manufacturing.
What is gene therapy process development at Element?
Gene therapy process development involves comprehensive analytical testing and manufacturing support to ensure therapeutic effectiveness and patient safety. At Element, we provide customized analytical methods and regulatory support throughout your product’s lifecycle, helping bring life-changing results with both IND and BLA submissions. Our support addresses the critical need for more indications while the industry faces mounting pressure to reduce cost-per-dose.
What can Element offer you for Gene Therapy Process Development & Manufacturing Support services?
Components And Products We Test
Components And Products We Test
We analyze your gene therapy products using comprehensive testing approaches for viral vectors, capsids, genome titers, and process residuals. Our testing ensures the highest standards of safety, identity, quality, purity, and strength for your gene therapy products.
Key Tests Offered
Key Tests Offered
- Empty/full capsid determination by UPLC
- Vector genome and total viral particle titer analysis
- Viral vector purity testing
- Potency and transduction method development
- Peptide mapping
- Residual material detection (polyethylenimine, iodixanol, benzonase, host cell protein)
Methods And Solutions Offered
Methods And Solutions Offered
Our QC-centric approach helps identify and solve challenges early in your development process, building scientific confidence that your gene therapies will hit their mark and cure difficult diseases. We customize analytical methods to your specific needs while maintaining the highest safety and reliability standards, supporting both IND and BLA regulatory pathways.
Gene therapy analytical methods and services:
- Determination of empty/full capsid by UPLC
- Determination of vector genome and total viral particle titer by SDS-PAGE or capillary gel electrophoresis
- Determination of viral vector purity
- Method development for potency and transduction
- Peptide mapping
- Residual polyethylenimine, iodixanol, benzonase, and host cell protein detection
Cutting-Edge Equipment We Use
Cutting-Edge Equipment We Use
- Dedicated mammalian cell culture facility
- Capillary electrophoresis systems
- Custom-setting stability chambers
- Advanced chromatography and mass spectrometry (QTOF and QExactive systems)
Which Labs Offer This Service
Which Labs Offer This Service
Our 9,000-strong team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Materials we test
Viral Vectors and Components:
- Adeno-associated viruses (AAVs)
- Vector genomes
- Viral particles
- Empty/full capsids
Process Materials:
- Host cell proteins
- Polyethylenimine
- Iodixanol
- Benzonase
Your Challenges, Our Solutions
High Development Costs
Critical Patient Safety Requirements
Aggressive Time-to-Market Pressure
Complex Regulatory Compliance
Why Choose Element
Quality-Focused Development Strategy
Comprehensive Lifecycle Support
Customized Solutions
Deep Scientific Expertise
Disease-Specific Expertise
Element support gene therapy development across multiple therapeutic areas, including cancer treatments and rare genetic conditions. Our experience spans both in vivo and ex vivo vector strategies, to help you develop targeted solutions for specific disease communities while meeting the highest safety standards.
Frequently asked questions
How do you ensure patient safety in gene therapy development?
Patient safety remains a top priority in the clinical success of gene therapies, especially with over 1,000 clinical studies targeting conditions like cancer, 𝛽-thalassemia, and sickle cell anemia. While efficient vector strategies are crucial, patient safety must always come first. Accurate viral vector analysis, particularly with adeno-associated viruses (AAVs), is essential for successful gene transfer.
Element’s expertise in viral vector analysis, combined with our deep scientific, regulatory, and industry knowledge, allows us to design custom gene therapy methods and CMC strategies that ensure safety, reliability, and the best possible outcomes.
Explore our global network of labs and find your nearest location
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