Gene Therapy Formulation Quality Control
Inquiry
The quality control of gene therapy formulations utilizes risk assessment, whole-process control, and whole-life management to ensure the safety and efficacy of gene therapy products, and to achieve stability and consistency of quality through quality control at each production stage. CD Formulation aims to provide comprehensive testing solutions for gene therapy formulation quality control to help customers accelerate the progress of gene therapy formulation development.
Importance of Gene Therapy Formulation Quality Control
Gene therapy preparations have become a hot spot of drug research and development in recent years. Carrying out quality research on gene therapy preparations at the research and development stage and establishing corresponding quality control methods and quality standards are important guarantees of product safety and effectiveness and one of the important links in the process of industrialization. In the process of research and development as well as large-scale production of gene therapy preparations, quality control research and testing of gene quality products is an important link to ensure their safety and effectiveness.
Explore Our Gene Therapy Formulation Quality Control
Gene Therapy Formulation Impurity Testing
We provide comprehensive impurity testing assays for gene therapy formulations. Our impurity testing studies are conducted throughout the entire life cycle of gene therapy formulation development to control quality risks and ensure the safety and efficacy of gene therapy formulations. Our services include, but are not limited to, those listed below.
CQA for viral vector-based products. We focus on product-related impurities, process-related impurities, nucleic acid and protein shell properties, safety factors, etc., involving several testing items, such as viral testing, residue testing, biological activity, etc. We also provide a wide range of product-related impurity testing services, such as characterization, characterization, characterization, characterization, characterization, characterization and analysis.
Multi-dimensional characterization. We analyze at the nucleic acid level, protein shell level, and intact virus particle level, including genome sequencing, protein identification, and particle property analysis.
- Purity detection. We test for host cell components, process additive residues, and product-related impurities.
- Biological activity. Used to assess gene transfer efficiency, target gene expression levels, etc.
- Content assay. Includes detection of viral particle number, genome copy number, etc.
- Safety tests. For example, sterility check, endotoxin check, etc.
Gene Therapy Formulation Stability Testing
Gene therapy products use viruses as vectors and are genetically unstable and variable. The stability studies we offer are designed to ensure the stability of the product during shelf life, transportation, and use, especially tolerance to harsh environments and temperature changes. Studies on the stability of gene therapy formulations can predict the effect of special conditions on the product and assure commercialization.
- Properties related to stability. Gene therapy products are special biological products whose active ingredients are living organisms composed of nucleic acids and proteins, which are sensitive to environmental changes, especially to heat, ultraviolet light, freezing, and thawing. Viral particles are easy to aggregate, the dosage form is mostly liquid, stability studies need to be carried out based on these characteristics.
- Key elements of our stability studies. We do this by developing an overall plan that includes samples, conditions, projects, timing, transportation studies, and analysis of results. The studies are categorized into long-term stability studies, accelerated stability studies, and forced condition tests.
- Examination of conditions. The study conditions need to cover the entire process of storage, transportation, and use. Conditions include temperature, repeated freezing and thawing, light, humidity, etc.
- Testing programs. We provide testing programs including activity, purity and impurities, content, particle characteristics, etc.
Our Process of Gene Therapy Formulation Quality Control
- Primary and secondary material selection, quality control, and management.
- Vector seed lot preparation, quality control, and management.
- Preparation, quality control, and management of cellular matrix for production.
- Quality study in production condition guarantee, process control, and process validation.
- Quality control study of product release inspection program.
- Quality control of product stability.
Our Platforms for Gene Therapy Formulation Quality Control
| Technologies & Platforms |
Test Content |
| HPLC, CE, UV |
Plasmid superhelix
mRNA purity, integrity
Virus empty capsid |
| PCR, q-PCR, dd-PCR |
Copy number
Genomic titer
DNA residue |
| LC-MS, AUC |
Virus empty shell rate
Product structure characterization |
| Flow cytometer, microscope |
Cell characterization
Antigen expression assay |
Highlights of Our Gene Therapy Formulation Quality Control
- Customized service. We have a perfect analytical testing platform, a professional testing team, and diversified high-end analytical testing instruments and equipment, that can provide personalized customization according to customer needs.
- Technical consulting service. We can provide personalized technical consulting and training services to avoid risks for customers in advance.
- One-stop testing service. We provide a one-stop project analysis, research, and testing strategy, which greatly provides project development efficiency.
- Comprehensive testing services. We provide compliance testing and general testing services, covering multiple stages of gene therapy formulation development.
CD Formulation is an industry leader in quality control of gene therapy formulation development, and we are committed to providing specialized quality control testing services for gene therapy formulations. If you are interested in us, please feel free to contact us.
Related Services
