Gene therapy brings life-changing drugs to patients, and even brings hope of a cure for patients with chronic diseases. The scalable viral vector process needs to be quickly optimized to meet the needs of clinical approval and commercial cGMP manufacturing to keep up with the rapid development of the clinical field.
Alfa Chemistry understands the ups and downs you face in providing powerful, reproducible, and scalable gene therapy viral vectors. We have mature and scalable technologies, platforms, knowledge, and services that can help you bring gene therapy to the market. Work with us to increase your commercialization speed or increase process productivity and provide treatments to change lives.
Accelerate and Optimize Viral Vector Process
With the support of our experts, you can overcome development and optimization obstacles. Our process development services specialize in designing, optimizing, and transferring scalable processes from preclinical to cGMP commercial manufacturing, thereby reducing time to market. Our team can learn from the experience of multiple gene therapy viral vector projects to cooperate with you. Together, we can quickly optimize your process, whether it is to prove the readiness for industrial-scale production or increase production capacity. Please contact us to learn about accelerator process development services.
Purification of Viral Vectors
The ratio of impurities to protein, the charge and size of the viral vector, and the risk of empty capsids all pose challenges for purification. Optimized filtration and chromatography solutions can maximize yield. A series of robust and scalable purification technologies are effectively combined to reduce residual plasmid DNA, host cell DNA, and empty or partially filled vectors and other impurities to provide the high purity, high concentration, and efficiency you need.
- Clarification of the harvest carrier: the removal of cells and cell debris requires careful application of filters, whose structure can retain large and fine debris while maintaining high yields. The combination of optimized depth filtration and sterilization grade filtration can ensure low particle feed and high virus transmission for downstream purification.
- Chromatography: Membrane-based ion-exchange chromatography provides high capacity, high purity, and can be used in conjunction with a disposable automation platform to simplify operations and increase process flexibility.
- Ultrafiltration: Diafiltration and concentration of intermediates and final products can be achieved using disposable cartridges and systems to simplify processing.
- Sterile filtration of purified carriers: Sterilization-grade filter capsules strike a balance between sterility assurance and high transmission of viral particles, and can be pre-sterilized and provided as part of a multi-component system designed to simplify your manufacturing process.
Cell Amplification and Virus Production
Efficient transfection and scalable cell culture are two upstream obstacles that need to be overcome. Our solutions support you in designing a robust, repeatable and scalable viral vector generation process. One-time, scalable cell culture projects support suspension and adherent production cell lines, cell expansion, virus transfection, and virus production. All production systems are designed to maintain a sterile and closed manufacturing environment and be automated to ensure consistent operation and product quality.
- Adherent cells: Our unique fixed-bed bioreactor can maintain the simple scale-up of closed system production with a small footprint on all scales.
- Suspension cells: For suspension culture, a series of disposable, expandable stirred tank bioreactors can be used to support cell expansion and carrier production of various scales.
The preparation, storage, and transfer of culture media, buffers, intermediates, and final drugs need to be carefully controlled to prevent contamination. Our fluid handling technology series can be used as part of a pre-assembled, sterile system, or as a component added to an existing process. They support a one-time manufacturing platform to reduce bottlenecks, and are easy to use, reduce process deviations and ensure quality.
- Aseptic Connection and Disconnection: Aseptic connectors and disconnectors can be integrated with existing process components at any time or provided as part of a disposable system, providing an easy-to-use and safe method for connection and disconnection in hose assemblies.
- Fluid Handling: From simple fluid transfer devices to mixing solutions that provide sterile cell culture media or buffers for your process, these solutions can simplify production, ensure cleanliness, and simplify operations to support rapid process development.