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:
Copy number analysis
Sequence confirmation of construct
by Sanger sequencing
Structure analysis via
Southern blot analysis
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
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 T
Contact Us for More Information
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.
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.
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.