GLP-compliant Confirmatory Sequencing
GENEWIZ’s Confirmatory Sequencing under Good Laboratory Practice (GLP) guidelines provides confirmation of the biologic using Sanger sequencing to support FDA- and EPA- submissions.
GLP-Compliant Services (Regulatory)
Good Laboratory Practice (GLP) services from GENEWIZ are designed to be compliant with US FDA (21 CFR Part 58) and US EPA (40 CFR Part 160) regulations to support pre-marketing authorizations.
Clinical Genome Sequencing (CLIA / CAP)
Clinical Genome Sequencing provides a CLIA-validated comprehensive analysis of the entire genome to uncover mutations in coding and non-coding regions, including structural and copy number variants.
Clinical Exome Sequencing (CLIA / CAP)
Clinical Exome Sequencing is a CLIA-validated method to probe protein-coding regions of the genome at high depth and with uniform coverage. Our regulatory service provides whole exome sequencing services in our GCP-compliant, CAP-accredited laboratory.
CLIA Sanger Sequencing
GENEWIZ provides CLIA Sanger sequencing as the clinical "gold standard" from our state-of-the-art CLIA-certified and CAP-accredited laboratory.
CLIA Variant Confirmation (PCR + Sanger)
CLIA variant confirmation via PCR + Sanger sequencing is used to detect or confirm mutations within genomic DNA.
Clinical Services
To support pre-clinical and clinical regulatory submissions, GENEWIZ has established Good Laboratory Practices (GLP) and Clinical Laboratory Improvement Amendments (CLIA)-compliant workflows.
AAV Plasmid Preparation
GENEWIZ AAV Plasmid Preparation service delivers superior quality for midi to giga-scale AAV vectors, while maintaining the integrity of ITR regions.
Targeted Yield Plasmid DNA Preparation
GENEWIZ Targeted Yield Plasmid DNA Preparation Service delivers specific quantities of high quality, transfection-grade DNA that you can count on.
Standard Plasmid DNA Preparation
GENEWIZ Standard Plasmid DNA Preparation Service is a flexible and fast choice for a range of plasmid templates.