Biologics testing solutions ensure reproducible results across the preclinical to production pipeline. Confirmatory sequencing under Good Laboratory Practice (GLP) guidelines provides confirmation of your biologic using Sanger sequencing to support FDA- and EPA- submissions. The right sequence means the right product!
GENEWIZ can characterize samples for identity and stability from preclinical stages through the manufacturing pipeline. We utilize validated methods according to ICH Q2 guidelines to support analysis of your monoclonal antibody therapeutics, immunotherapeutics, viral vectors, vaccines, and agricultural products.
Simply provide your master cell bank (MCB), working cell bank (WCB), viral particles, viral vector, master virus stock (MVS), gDNA, mRNA, plasmids or PCR products. GENEWIZ will design, develop, and optimize assays to verify identity and stability. Our experienced scientists and Quality Assurance Unit ensure that your samples are processed and results reported according to applicable regulatory standards to support IND, NDA, ANDA and BLA applications.
Standalone Sanger sequencing services are also available at the GLP-compliant level for integration into client analysis programs.
Validation of Medical Device Assays coupled with GLP-compliant Sanger sequencing of clinical samples to support medical device applications are also available.
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