Gene Therapy Analysis Services

Welcome to our Gene Therapy Analysis Services! With over two decades of experience supporting gene therapy development, we offer comprehensive analytical services tailored to facilitate the development and regulatory approval of various gene therapy modalities. Below, you’ll find an overview of each type of gene therapy we support, along with the analytical and bioanalytical services we offer to support preclinical and clinical studies, as well as CMC.

Our Expertise

We specialize in quality control, product release, and bioanalytical testing, to support all phases of gene therapy products from development through manufacture. Our contributions to preclinical and clinical studies have been instrumental in securing numerous successful gene therapy approvals.

Preclinical/Clinical Testing (GLP or non-GLP)

Vectors

Experience

Viral Vector

Since the early 1990s, we have been actively supporting gene therapy utilizing viral vectors such as AAV, adenovirus, lentivirus, and vaccinia virus.

Plasmid

Our team excels in providing comprehensive analytical support of plasmid gene therapy, from vector design and construction through preclinical testing and clinical study support.

Microbial Vector

We have experience supporting clients utilizing microbial vectors, such as Salmonella, to deliver therapeutic genes to target cells or tissues.

In Situ sgRNA/mRNA in LNPs

We leverage advanced qPCR, ddPCR, and NGS tools to deliver innovative analytical and bioanalytical methods supporting in situ sgRNA and mRNA therapies.

mRNA in LNPs

Since 2015, we have been a pivotal partner to one of the leading mRNA vaccine developers, offering extensive expertise in supporting mRNA vaccine and therapeutics.

Analytical Support Through All Stages of Product Lifecycle

Phase

Technologies

Applications

Development

qPCR, ddPCR, PCR, Sanger Sequencing, NGS, HPLC, Flow Cytometry, cloning, CRISPR/cas9

Gene editing profiling
Cytokine release assays
Surface marker analysis
Integration site analysis

Preclinical

qPCR, ddPCR, NGS, ELISA, MSD, Western blot

PK/PD studies
Dose quantitation
Biodistribution studies
Gene expression analysis
Protein expression analysis
Gene editing profiling
Immunogenicity study

Clinical

qPCR, ddPCR, NGS, ELISA, Western blot

Patient stratification
PK/PD studies
Gene expression analysis
Protein expression analysis
Gene editing profiling
Immunogenicity testing
Genotyping

CMC Support

qPCR, ddPCR, PCR, Sanger Sequencing, NGS, Flow Cytometry, compendial assays

Identity assays
Potency assays
Vector genome integrity testing
Stability testing
Replication competent virus testing
Copy number variation (CNV) testing
Adventitious agents testing
Sterility testing
Mycoplasma testing
Endotoxin testing
Bioburden testing
Residual DNA assays
Residual host cell protein assays
Other release assays

Have Questions?

We are dedicated to providing timely, high-quality service for your project from start to finish. Send us a quick message with your questions to find out what Avance can do for you.