Adeno-associated virus (AAV) vectors are the most widely utilized gene therapy delivery technology currently being developed. AAV comes in a variety of serotypes, each of which can target distinct types of tissues. Its capacity to transduce non-dividing and dividing cells, as well as the fact that it is non-pathogenic and cannot replicate on its own, promotes safety.
Although significant progress has been achieved in the creation of commercial production-scale gene therapy methods in recent decades, problems remain, particularly in terms of upgrades. Alfa Chemistry offers a variety of powerful and scalable solutions, as well as the technical expertise and experience to guide you through each stage. The majority of AAV vector manufacture follows a similar fundamental procedure, with minor variations as needed.
Upstream
Adherent Cell Seeding and Culture
For most cases, viral vectors are created utilizing a two-dimensional system in adherent cells. Culturing cells in this manner becomes a difficulty as the procedure scales up and more viruses are required.
- The Multiplate Bioreactor is a closed disposable system for multiplying shear-sensitive adherent mammalian cells under regulated circumstances.
- Creating viruses from adherent cells using our fixed-bed bioreactor technology enables for direct transfer of 2D reference processes, reducing risk and saving time.
Suspension Cell Culture
Manufacturers are increasingly looking to produce viral vectors for gene therapy in suspension cell culture as the demand for scalability grows. Like most cases, viral vector production in suspension culture necessitates additional testing and improvement. Our disposable stirred-tank bioreactors have been meticulously engineered to ensure process reliability and availability.
Clarification
After cell cultivation, the first step is to eliminate cells, cell debris, and other contaminants. Low yield is a common issue in this stage, particularly when upstream cell density and virus particle size rise.
Our skilled technical staff can assist you in achieving high throughput and output by optimizing the program and settings of this step: disposable deep filtration system, deep filtration capsule, single Layer V100P medium grade capsules, and so on.
Downstream
Bioburden Filtration
The following stage in this process is usually to reduce the bioburden using an appropriate filter. The sort of filter utilized here depends on the material's titer and volume, the fluid's fouling properties, and the processing time requirements.
Our Bioburden Reduction Filters can effectively and cost-effectively reduce the bacterial load in the feed to an acceptable low level, safeguarding the process against microbial and particle contamination.
Purification (Chromatography)
Empty capsids, DNA, and host cell proteins are removed during the polishing process. Adsorption membrane technology is a cost-effective and efficient way to improve gene therapy products.
The scalable, high-performance Membrane Chromatography Capsules are dependable and simple to use, allowing users to enhance process economics by lowering buffer usage, boosting production, and lowering capital costs.
Disposable membrane chromatography units with Q and S chemical components are suited for scale-down process development work in a variety of downstream process applications.
Bulk Drug Substance Filtration
A last sterile-grade filtration process is normally necessary before the item is delivered for final filling. From mAbs, recombinant proteins, vaccines, and gene therapy to small molecule pharmaceuticals and plasma derivatives, our broad selection of sterile grade liquid filters and formats enables us to provide filtration solutions for a wide range of applications and drug types.