Unique mid-scale system for R&D and GMP manufacturing
The scale-X™ carbo system is a flexible, highly productive and GMP compatible platform for the production of viral products. It features a cell growth surface area of 10 or 30 m² which integrates in-line product concentration function. The scale-X carbo system is ideally placed for mid-scale production enabling process development and GMP manufacturing.
The system facilitates the development of a scalable process for transfer to the the scale-X nitro bioreactor (integrated into the NevoLine™ Upstream platform). It also enables clinical and commercial production in its own right with a full GMP offering.
Automated control, process integration and GMP production
The scale-X carbo controller integrates both cell culture and product concentration.
This is achieved by combining the controls necessary to operate the fixed-bed bioreactor as well as to concentrate the product using in-line tangential flow filtration, all through the same interface.
The combination of two operations in one reduces the total volume of process material and the equipment footprint, contributing to reducing the product cost of goods.
While enabling the flexibility required for process development, its proprietary software also enables 21CFR part 11 compliance by end-users by providing advanced user access control, data recording and audit trail functions.
Consumables adapted to the needs of process development and GMP production
The scale-X carbo single-use range consists of bioreactors and liquid handling assemblies.
To reflect different needs during process development and GMP manufacturing, the range is available in two applications:
Gaining process understanding requires flexibility in process design.
The scale-X carbo R&D products allow flexible connections enabling the development of multiple process configurations.
Clinical and commercial manufacturing requires GMP compliance and the elimination of aseptic risk.
The scale-X carbo GMP products ensure all liquid connections can be done as a closed system using a choice of welding or aseptic connectors. The products are provided with a validation guide detailing compliance to GMP regulatory requirements.
To support your journey, we offer a full range of services that include installation, training, IQ/OQ and PQ support as well as maintenance and technical support.