Our analytical offering helps interrogate your process and product early-on, helping you make decisions faster and avoid common pitfalls in cross-modality development.
We hold an extensive toolkit of plug-and-play & custom-built analytical assays, as well as a number of GMP certified QC tests.
– Residual DNA Tests for Plasmid / Vector / Transgene*
– NGS for vector genome and impurity characterisation
– Endotoxin
– Subvisible Particles
– Process Residuals*
– Dynamic Light Scattering
– SEC
– Full / Empty Methods
– Capsid Concentration*
– In vitro Cell-Based Relative Potency Assays*
– Vector Genome Concentration*
– Infectious Titre*
– Viral Protein
– Packaged Dimers
– Conformational Stability
– Vector Genome Integrity
– Residual DNA Tests for Plasmid / Vector / Transgene*
– NGS for vector genome and impurity characterisation
– Endotoxin
– Subvisible Particles
– Process Residuals*
– Dynamic Light Scattering
– SEC
– Full / Empty Methods
– Capsid Concentration*
– In vitro Cell-Based Relative Potency Assays*
– Vector Genome Concentration*
– Infectious Titre*
– Viral Protein
– Packaged Dimers
– Conformational Stability
– Vector Genome Integrity
*available to GMP
We offer QC testing under GMP at our Munich and Alachua sites – including DNA impurities, vector genome titer, capsid titer, infectious titre and process residuals.
Our state-of-the-art techniques, such as droplet digital PCR (ddPCR) and automated immunoassay, offer advantages over traditional approaches like qPCR and manual ELISA while requiring only small sample volumes for analysis.
Please contact us using the form below.
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Validated GMP QC assays to more reliably assess DNA impurities for rAAV batch release
