Increase the viability of gene therapy programs
Optimized methods lower manufacturing costs and save significant time and money when workflows begin to scale. Ensure a speedy gene-to-clinic strategy when you partner with Element.
Advance gene therapies with a global partner
You'll benefit from Element's fully integrated service platform with a wide range of orthogonal analytical methods and capabilities. Together, we'll determine what assays, methods, and instruments are best to help reach your goals.
Plus, we tailor methods and CMC strategies to meet the unique needs of your gene therapy. We'll be by your side from discovery to gene therapy process development, manufacturing, and beyond.
Meet aggressive timelines
Meet and accelerate timelines for IND and BLA submissions without sacrificing quality. Get your gene therapy to market faster - leverage Element's QC-centric mindset, flexibility, and deep scientific and regulatory expertise.
Ready to bring your gene therapy to market faster?
Let us know what you're looking for in two easy steps:
- Click on the orange "Get more information" button
- Fill out the "Ask a question" form
A member of our team will be in touch with you.
Your global partner from discovery to market
Still researching? Here are a handful of our many services to help achieve regulatory approval quickly and efficiently.
Cell Culture & Cell-Based Bioassay Services
Element's cellular assay experts provide best-in-class cell culture and cell-based bioassay services for biologic drug discovery and development programs.
Pharmaceutical and Biopharmaceutical Unknown Identification and Impurity Testing
Our experts work closely with customers at every stage of the product lifecycle to identify unwanted compounds and ensure products are pure, safe, and quality.
Chemistry, Manufacturing, and Controls (CMC) Consulting Services
We provide consulting services for Chemistry, Manufacturing, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
CMC Product Development Services
Our CMC product development services include formulation development, parenteral and topical product development, microbiology testing services, and consultancy.
Pharmaceutical Stability Storage and Testing
Element offers advanced pharmaceutical stability testing and ICH storage services to ensure the maintenance of product quality, safety and efficiency throughout the shelf life.
Compendial Testing
ICH, USP, EP, BP and JP monograph tests of raw material, drug substance/product, starting material, cell banks, vectors, bulk harvest and control cells.
Disinfection Qualification
Element offers Disinfection Qualification studies for the pharmaceutical industry and Disinfectant Efficacy studies for the antimicrobial industry.