Bioprocess Testing Services

Testing for Biologics Manufacturing under GMP Regulatory Guidelines

Avance Biosciences™ is a leading provider of biologics safety testing for gene edited cell drug products and eucaryotic/procaryotic cell lines.Our GLP/GMP compliant genomic and biological assays make use of the most advanced analytical technologies. The Avance Biosciences™ team is committed to strict adherence to CGMP and GLP regulations as required by the US, European, Japanese, and other international regulatory agencies. Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from pharmaceutical and biotechnology companies throughout the world.

Cell Bank Testing

Avance offers a variety of genomic and microbial assay services to support cell based manufacturing testing. Avance provides a suite of Genetic Stability Testing assays for MCBs, WCBs and EOPCs. Assay services include:

Marker retention
Copy number analysis
Sequence confirmation of construct
by Sanger sequencing

Structure analysis via
Southern blot analysis
Purity
Phage detection

Lot Release Testing

Avance provides genomic assays to support Lot Release Testing under GMP guidelines for biologics, viral based vaccines and gene edited drug products. We can support assay development, GMP assay validation and GMP sample testing of your drug product. Assay services include:

Plasmid ID sequencing
Residual DNA assays

Copy number analysis
Viral titer via qPCR and ddPCR

Gene & Cell Therapy Product Testing

Avance has the experience and services to support manufacturing efforts for gene & cell therapy products. We have supported numerous projects and clients that are engaged in the production of these types of drug products. Assay services include:

Vector copy number (VCN) for
CAR-T therapies
Replication competent lentivirus
(RCL) for CAR-T
Copy number for inserted gene

On/off target NGS assays for
gene edited cell drug product
Translocation assays by ddPCR
sgRNA ID testing by NGS
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When you partner with Avance Biosciences™, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!

Dedication to Quality

The Avance Biosciences™ team is committed to strict adherence to GLP and CGMP regulations enacted by the US, European, Japanese, and other international regulatory agencies.

Extensive Experience

Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from over 100 pharmaceutical and biotechnology companies and organizations throughout the world.

Open Communication

Transparency and integrity are two of our core values. Our well-trained, friendly, and professional study directors and project managers strive to complete your projects on-time with open communication channels and to your specifications.

Cutting Edge Science

Avance Biosciences™’ GLP/GMP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, digital PCR, Sanger sequencing, next generation sequencing, and more.