Analytics
Our analytical testing ensures the safety, efficacy, and compliance of your advanced therapies.
Ensuring Quality and Safety Through Advanced Analytical Testing
Analytical testing is essential to the successful development of genetic medicines 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 27,000 research batches 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
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Accurate, Reliable, and Scalable
Analytical Testing
Partner with us for expert analytical testing and characterization services that support every stage of your genetic medicine development.
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