Next Generation Sequencing for Cell and Gene Therapy

[Article Title]

Biosafety testing is required for all biopharmaceuticals, including monoclonal antibodies, antibody drug conjugates (ADCs), vaccines, and the more advanced modalities, including cell therapy, gene therapy, and mRNA products.

With the unique nature of gene therapy, traditional GMP biosafety characterization and release methodologies may not be appropriate, and the use of alternative test methods are required. One primary alternate method being widely adopted across the industry is Next Generation Sequencing (NGS).

Using NGS in place of in vivo testing as part of a complete biosafety program allows clients to meet or exceed product milestones and to deliver critical therapies to patients faster than traditional methods. Download this white paper to learn how NGS provides high quality, regulatory-accepted results to assure product safety and accelerate getting medicines to patients.

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