Analytical Testing
Analytical testing of advanced therapeutic products is crucial for the successful development of genetic medicines. Comprehensive characterization of the drug product and drug substance during the preclinical through to the clinical stages is vital for understanding the biological effects as well as meeting the criteria set out by regulatory bodies around the world. The evolving field of analytical testing employs cutting-edge technologies to ensure quality and safety standards are met.
Our Expertise
The team at Franklin Biolabs provides comprehensive, robust analytical services for any project. Our AAV manufacturing experience includes >27,000 research batches and >100 large-scale runs spanning 30 clinical candidates and 12 serotypes over the last five years, as well as >50 clinical-stage programs based on our AAV capsid technology. Our experts are at the forefront of analytical and regulatory science for genetic medicines and offer a variety of drug substance and drug product characterization options.
Our Services
Next-Generation Sequencing
Learn more about our NGS services here
Particle Characterization
% Full (AUC and Mass Photometry)
Sizing/aggregation (DLS and SEC-MALS)
Purity (SDS-PAGE and CE-SDS)
Titer
ddPCR
Compendial Assays
Appearance, osmolarity, pH
Excipient Analysis
Buffer/salt and P188 concentration
Mass Spectrometry
Protein identification and expression, post-translational modifications
Cell-Based Potency
Expression (ELISA, in-cell Western, MSD) and function (various)
TCID50
Residuals
Host Cell Protein (ELISA) and DNA
BSA, PEI, LDAO, SAN-HQ, Leached Affinity Ligand
Safety
rcAAV
Endotoxin
Custom Assay Development
Please inquire for custom assay services
