Adeno-associated virus (AAV)-based gene therapies are the most common type of gene therapy developed today yet still very complex to manufacture and to ensure the safety and efficacy of the product. These challenges are compounded by insufficient industry-wide analytical best practices, reference standards and standardized methods.
USP is developing solutions that address these gaps and support viral vector characterization testing and product- and process-related impurity assessment.
Explore the Gene Therapy Analytical Guide, an online interactive tool that places quality control solutions at your fingertips.
AAV8 (Empty/Full Capsids) – Coming Soon! Endonuclease (Serratia marcescens) – Coming Soon! Plasmid for Residual DNA Quantification
Quantitative AAV Titration PCR Control
Quantitative HEK-293 Genomic DNA
Quantitative Sf9 Genomic DNA
USP solutions to confidently measure residual plasmid DNA in gene therapy products
Advancing quality standards for gene therapies: a USP perspective
Visit us in New Orleans at ASCGT. See you May 13-17 at booth #428.
New reference materials to support quality of raw materials and critical components.
New AAV reference Materials for CQA assessment
New reference materials to measure process related impurities
- Reference Standards
- Endonuclease (Serratia marcescens) – Coming Soon
- AAV8 (Empty Capsids) - Coming Soon
- AAV8 (Full Capsids) - Coming Soon
- Analytical reference materials
- Plasmid for Residual DNA Quantification
- Quantitative AAV Titration PCR Control
- Quantitative HEK-293 Genomic DNA
- Quantitative Sf9 Genomic DNA
- AAV1 for Capsid Titer - Coming Soon
- AAV2 for Capsid Titer - Coming Soon
- AAV5 for Capsid Titer - Coming Soon
- AAV8 for Capsid Titer - Coming Soon
- AAV9 for Capsid Titer - Coming Soon
Click here
- <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
- <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
- <63> Mycoplasma Tests
- <71> Sterility Tests
- <85> Bacterial Endotoxins Test
- Reference Standard: USP Endotoxin RS
- <89> Enzymes Used as Ancillary Materials in Pharmaceutical Manufacturing
- Reference Standard: USP Trypsin Recombinant Porcine RS
- <507> Protein Determination Procedures
- Reference Standard: USP BSA for Protein Quantitation RS
- <509> Residual DNA Testing
- Reference Standard: USP CHO Genomic DNA RS
- Reference Standard: USP E. coli Genomic DNA RS
- <785> Osmolality and Osmolarity
- <788> Particulate Matter in Injections
- Reference Standard: USP Particle Count RS
- <789> Particulate Matter in Ophthalmic Solutions
- <790> Visible Particulates in Injections
- <791> pH
- <1040> Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies
- <1042> Cell Banking Practices for Recombinant Biologics
- <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- <1044> Cryopreservation of Cells
- <1047> Gene Therapy Products
- <1050> Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
- <1071> Rapid Sterility Testing of Short Life Products A Risk Based Approach
- <1085> Guidelines on the Endotoxins Test
- <1103> Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
- <1104> Immunological Test Methods—Immunoblot Analysis
- <1125> Nucleic Acid-Based Techniques—General
- <1126> Nucleic Acid-Based Techniques—Extraction, Detection, and Sequencing
- <1127> Nucleic Acid-Based Techniques—Amplification
- <1128> Nucleic Acid-Based Techniques—Microarray
- <1130> Nucleic Acid-Based Techniques—Approaches for Detecting Trace Nucleic Acids (Residual DNA Testing)
- <1132> Residual Host Cell Protein Measurement in Biopharmaceuticals
- <1430.3> Analytical Methodologies Based on Scattering Phenomena—Dynamic Light Scattering
- <1776> Image Analysis of Pharmaceutical Systems
- <1787> Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections
- <1788.3> Flow Imaging Method for the Determination of Subvisible Particulate Matter
- <1790> Visual Inspection of Injections
Click here
- Viral Vector Manufacturing and Control Strategies
- Quality Considerations for Plasmid DNA as a Starting Material for Cell and Gene Therapies
- USP Standards and Best Practices for Gene Therapy
- What’s New in Biologics? Standards to Support Advanced Therapies
- Opportunities and Challenges in Raw Material and Starting Material Qualification for Cell and Gene Therapy Products
Click here
