Gene Therapy cGMP Manufacturing
Inquiry
As the value of gene therapy formulations in the treatment of disease emerges globally, the compliance and quality control of their manufacturing process has become a central issue in the industry. Current good manufacturing practice (cGMP), as the international standard for drug manufacturing, is of particular importance in the gene therapy field. CD Formulations is an industry leader in the development of gene therapy formulations, and we remain committed to the development and manufacture of gene therapy formulations.
Importance of Gene Therapy cGMP Manufacturing
- Ensure clinical safety and efficacy. The in vivo properties of gene therapy formulations are extremely sensitive to the production environment and process stability. cGMP can minimize batch-to-batch variation and safeguard patient safety through strict sterility control, process validation (e.g., viral titer testing, cellular activity monitoring), and data analysis.
- Meet regulatory agency requirements. The development and manufacture of gene therapy formulations require comparability studies to verify the impact of changes on product quality. For example, a change in plasmid source for viral vector production requires multi-dimensional analysis of host protein residues, vector efficacy, etc. A systematic study design under the cGMP framework can accelerate change approval.
- Enhance the success rate of commercialization. The high cost of gene therapy requires companies to reduce costs and increase efficiency through cGMP optimization. For example, adopting disposable bioreactors reduces the risk of cross-contamination while shortening the device validation cycle.
Explore Our Gene Therapy cGMP Manufacturing
We have a GMP plant to assist our customers in the cGMP production of gene therapy formulations. So far, our technology and production capabilities have been widely recognized and valued by our customers, especially the end-to-end support capabilities, including plasmid production, cell banking and virulence banking, stock solution, or finished product production and filling. We offer both non-GMP and GMP production to meet the different needs of our clients at the preclinical or commercialization stage. Our GMP production meets the highest level of requirements for plasmid, viral vector, and cell production.
We have continuously improved and optimized our plasmid DNA production by optimizing our technology system according to the challenges in plasmid DNA production to assist our clients in GMP production for gene therapy research. Our services range from plasmid strain construction to GMP production, process optimization, and quality control (QC).
Cell and Strain Banking
The establishment of high-quality GMP master cell and strain banks as starting material is essential when starting a cell and gene therapy production program. Our experience in cell and strain banking enables us to better serve our clients. Our team specializes in cell and strain library construction, process characterization, clone screening, and GMP production.
Production of Stock Solutions and Finished Products
We provide non-GMP and GMP manufacturing services for viral vectors, gene therapy-related stock solutions, and finished products. All of our innovative production platforms are compliant with the requirements of international regulatory bodies. For gene therapy, we have established innovative and robust manufacturing platforms for AAV and lentiviral vectors. We offer advanced manufacturing platforms for non-GMP and GMP manufacturing at different production scales. We have up to ten viral vector production lines, enabling us to customize process methods, including wall affixation and suspension systems, to meet our customers' needs.
Filling
We can also provide stand-alone canning services, or filling services as part of an overall service.
We understand that our clients and partners have different needs at different stages of project development. We can provide the strongest solution for your gene therapy formulation process development across upstream and downstream operations.
Fig.1 Our process of gene therapy cGMP manufacturing. (CD Formulation)
Our Platforms for Gene Therapy cGMP Manufacturing
| Technologies & Platforms |
Content Description |
| Downstream purification technology platforms |
These include automated purification platforms, chromatography systems, and ultrafiltration and nanofiltration systems. |
| Single-use technology |
We build single-use bioreactors and purification systems as well as single-use fluid management systems. |
| Quality control and analytical equipment |
We have real-time monitoring systems and advanced analytical instruments. Examples include high-performance liquid chromatography (HPLC), mass spectrometry (MS), and flow cytometry. |
| Formulation and packing platforms |
We have established aseptic filling systems as well as lyophilization systems for the production of lyophilized formulations. |
Highlights of Our Gene Therapy Formulation Process Development
- Production environment and facilities. Our production sites comply with GMP requirements, including clean area design, air filtration, temperature, and humidity control to prevent contamination and cross-contamination.
- Continuous optimization of process development. We continuously optimize the production process of our gene therapy formulations to provide better gene therapy products.
- Strict quality control and testing. We strictly control the production process, including comprehensive quality testing of key materials, intermediates, and final products.
CD Formulation focused on the development and production of global cGMP-compliant gene therapy formulations for its customers. If you are interested in us, please feel free to contact us.
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