Element’s consultative team of biopharmaceutical scientists have extensive experience supporting gene therapy programs for both IND and BLA regulatory pathways.
Element uses a wide range of orthogonal analytical methods and capabilities to ensure the safety, identity, quality, purity, and strength of gene therapies, including a mammalian cell culture facility, capillary electrophoresis, stability chambers with custom settings, and chromatography and mass spectrometry, including Quadrupole Time of Flight (QTOF) and QExactive systems. Our comprehensive service support the entire product lifecycle, from discovery to gene therapy process development, manufacturing, and beyond.
Our blend of deep scientific expertise, regulatory knowledge, and industry experience allows us to design custom gene therapy analytical methods specific to the needs of each project while meeting the highest standards of safety and reliability.
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
The Element advantage
Element offers comprehensive, phase appropriate GMP services to support the development and manufacturing of leading-edge gene therapies, supporting both IND and BLA regulatory submissions. Leverage the deep regulatory expertise of our biologic experts and purpose-built labs to advance your gene therapy today.
For more information about Element’s advanced gene therapy services or to request a quote, contact us today.
Nearly 190 Years of Making Certain
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