Analytics

Our analytical testing ensures the safety, efficacy, and compliance of your genetic medicines and biologics.

Ensuring Quality and Safety Through Advanced Analytical Testing

Analytical testing is essential to the successful development of genetic medicines, biologics, and other advanced therapeutic products. Thorough characterization of both the drug product and drug substance in the preclinical and clinical stages is critical for understanding biological effects and meeting global regulatory requirements. As the field evolves, advanced analytical technologies play a key role in ensuring the highest standards of product quality and safety.

Expert Analytical and Regulatory Support

Our team offers comprehensive and reliable analytical services for any project. With over 10,000 research batches in total and more than 100 large-scale runs across 30 clinical candidates and 12 serotypes in the past five years, our AAV manufacturing experience is extensive.

We’ve also supported over 50 clinical-stage programs based on our AAV capsid technology. Our experts also provide a wide range of drug substance and drug product characterization options.

Analytical Services

Next-Generation Sequencing
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

Next-Generation Sequencing
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
Research and GLP Options

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
Research and GLP Options

Meet Our Team

Kevin Turner, PhD

Executive Director, Analytics

Kevin Turner, PhD, is a scientific leader with over 15 years of experience in analytical testing and CMC strategy for biologics and gene therapy. He currently serves as Executive Director of Analytics at Franklin Biolabs, where he leads a high-performing team focused on delivering analytical excellence and regulatory support.

Previously, at the University of Pennsylvania’s Gene Therapy Program, Dr. Turner advanced potency assay development and managed stability programs — experiences that shaped his deep understanding of the critical role robust potency assays play in product development.

Dr. Turner earned his Ph.D. in Chemistry from the University of Maryland Baltimore County and has authored numerous publications in gene therapy, viral vector characterization, and analytical sciences.