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PRODUCTS

  • Patient safety is critical for regulatory success. SeQure Dx specializes in off-target analysis services to reduce risk and improve the safety profile of gene-edited cell and gene therapies. Our advanced assays ensure precise editing confirmation and thorough risk assessment across viral and non-viral editing platforms.

  • With three clinical pharmacology units, access to 145,000+ hepatic/renal patients, and 100+ completed studies, we’re your partner for NDA-enabling trials.

  • Navigating the complex landscape of scientific and regulatory affairs is a challenge for biotech companies. That's why our team is committed to providing solutions tailored to meet these unique needs.

  • From product development to translation into clinical trials, GTx’s clinically validated scalable electroporation technology is equipped to handle your most complex cellular engineering demands.

    • Rapidly transfect from 75 thousand to 20 billion cells
    • Move forward with 21 CFR Part 11 enabled software
    • Develop quickly with an established regulatory path supported by a FDA Master File
    • Manufacture confidently with closed, cGMP-compliant, ISO-certified and CE-marked products
    • Enjoy MaxCyte’s proprietary Flow Electroporation® technology
  • Referenced in the new USP <1207> Chapter Guidance as a deterministic test method for container closure integrity testing.

WHITE PAPERS AND CASE STUDIES

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