CellGenix - www.cellgenix.com
As more cell and gene therapies become approved, there's been a rapid increase in the need for innovative solutions that help overcome current manufacturing challenges. Being a raw material supplier, CellGenix focuses on overcoming current GMP raw material connectivity and automation challenges. Our goal is to offer different GMP raw material formats that fit seamlessly in current and future cell therapy manufacturing processes.
In the latest CellGenix workshop at Phacilitate Leaders Europe, we identified the current raw material challenges in commercial cell therapy manufacturing:
- sterile connectivity of GMP raw materials – currently raw material handling must be performed in a Grade A/class I00 or 1000 clean room (Europe/USA)
- stability of reagents and raw materials
- small volume additions – dead volumes
- preparation time needed for raw materials, such as preparation of media batches, reconstitution of cytokines, manual steps or regular media exchanges
- supply chain issues
To overcome these challenges, we are developing different formats of our established GMP raw materials to allow easy introduction into closed cell culture systems. One new format we developed is CellGenix® GMP rh IL-2 in liquid solution supplied in a ready-to-use syringe. This syringe can be directly connected to cell culture devices or bags for fast and error-free application of the cytokine. It also allows for an easier and faster preparation of a medium master batch. This GMP raw material format can help reduce labor hours as well as manual handling mistakes, thereby reducing manufacturing costs and improving consistency of the manufacturing process. We will offer additional GMP raw material formats that will enable sterile connectivity to (automated) closed cell culture systems.
Securing your raw material supply chain
Scaling up/out the manufacturing process often means that different systems and technologies are used for the different clinical phases, from flasks to bioreactors to closed system automation. In addition to increased regulatory and quality needs, it remains a challenge to maintain a consistent product quality at different production scales.
Since scale up/out is associated with an increased need of raw materials, this could lead to supply issues as well as storage issues. Distribution of raw materials over several (global) manufacturing sites can, in addition, be a logistical challenge. Moreover, if the raw material handling is done manually it greatly increases labor hours and thereby cost of goods.
The safest way to eliminate possible problems with the supply of GMP raw materials is having a supply agreement in place well before large-scale manufacturing is planned to start. Giving the supplier a clear and reliable forecast of the amounts of raw material needed will allow the supplier to have enough products available on demand. As a supplier, this for instance allows us to produce large size batches that are reserved for one customer.
To be able to provide high-quality GMP raw materials at strongly increasing quantities we are currently validating a state-of-the art automated filling and freeze-drying line that will significantly increase our cytokine production. This will enable us to meet increasing demands for high quality raw materials caused by the strong growth of the market. We have also set up a warehouse at our US office to further improve our overseas supply chain for our American customers.
Open discussion on how to overcome current raw material challenges
In order to come up with further innovative solutions, we would like to initiate an open discussion with all stakeholders within the cell and gene therapy industry. We are therefore organizing an interactive workshop discussing how to overcome current critical challenges. Please join this breakfast workshop to take part in this discussion: