Adenoviral vectors are a form of a viral vector that can carry genes to a number of cell types and are one of the most often utilized viral vectors for developing new medicines and vaccines. Although significant progress has been achieved in the development of commercial production-scale procedures for gene treatments and vaccines in recent years, obstacles such as cell-associated viruses and scalability remain due to the efficiency of purification and recovery.
Alfa Chemistry offers a comprehensive choice of scalable and powerful upstream and downstream solutions, as well as the technical expertise and experience to support each step of the process. The majority of AV carrier production follows a similar fundamental method, with minor variations as needed.
Upstream
Adherent Cell Seeding
Virus vectors are often made in adherent cells utilizing a two-dimensional method in the early stages of treatment development. The footprint and manual processes necessary to generate cells in this manner quickly become a concern as the process scales up and more viruses are required.
Multiplate Bioreactor is a closed disposable system for amplifying shear-sensitive adherent mammalian cells in a controlled environment. It creates a microenvironment similar to that of a cell factory, but with a smaller footprint and complete environmental control.
Adherent Cell Culture
There is a need to boost the quantity and quality of viruses produced as medicines progress into the clinical development stage. Creating viruses from adherent cells in a fixed-bed bioreactor enables for direct transfer of 2D reference methods, reducing risk and saving time.
We can create a fully integrated high cell density bioreactor that combines the benefits of single-use technology with the benefits of bioreactors, decreasing processing time, floor space, labor, and cost, while also improving process assurance, robustness, and scalability.
Clarification
To reduce the biological burden, the first step following cell culture is to eliminate cells, cell debris, and other contaminants. Filtration is the simplest and most cost-effective method for clearing cell cultures. Our expert technical staff can help you achieve high throughput and yield by optimizing the program and parameters of this stage, in addition to selecting the optimal filter material and size.
A disposable depth filtration system is available. This ready-to-use platform is scalable in terms of both scale and performance to satisfy the needs of laboratories, pilots, and processes. Due to their multi-functional architecture, size, and available filter medium, depth filtration capsules may be seamlessly integrated into any development process, allowing for high throughput and recyclability for viral vector products.
Downstream
Bioburden Filtration
The following stage in this process is usually to reduce the bioburden using an appropriate 0.2 m or 0.45 m 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.
The bacterial load in the process feed is reduced to an appropriately low level by our technologically revolutionary bioburden control filter, effectively and cost-effectively protecting the process against microbial and particle contamination. The membrane is chemically inert, has low protein and excipient binding capabilities, and can be used in a variety of medicinal products.
Purification (Chromatography)
Empty capsids, DNA, and host cell proteins are removed in this stage (HCP). Purifying gene therapy products with adsorption membrane technology is a quick and easy process.
We've combined our expertise in membrane equipment design and chromatography to create a line of scalable membrane chromatography capsules with exceptional performance. These capsules are dependable and simple to use, allowing users to enhance process economics by reducing buffer usage, improving production, and lowering capital costs.
UF/DF
The target molecules are further concentrated and buffers are exchanged using ultrafiltration/diafiltration employing tangential flow filtration (TFF) membranes. TFF knows how difficult it is to achieve high production, but our specialists can work with you to optimize your UF/DF unit's functioning based on their experience.
The disposable tangential flow filter module is a gamma irradiation cassette module that can be used with a disposable TFF configuration. The disposable TFF module can provide a scalable format from 93 cm2 to 2.5 m2 of membrane area thanks to an integrated polyethersulfone (PES) membrane.
The Omega membranes in the T series cassettes are suited for development, pilot, and production-scale TFF applications in a variety of biological processes. They're very good in concentrating and diafiltration vaccines and conjugates, purifying and recovering monoclonal antibodies or recombinant proteins, and separating and purifying plasma.
Bulk Drug Substance Filtration
Clinical manufacturing necessitates the creation of high-purity, biologically active carriers that comply with regulatory criteria. A last sterile grade (0.2 m) filtration step is normally necessary before the product is shipped for final filling.
We can supply filtration solutions for all applications and medication types, including mAbs, recombinant proteins, vaccines, and gene therapy, as well as small molecule pharmaceuticals and plasma derivatives, thanks to our extensive selection of sterile grade liquid filters and formats.