Charter Medical case study customised bioreactor design

CASE STUDY: Customised Bioreactor Design

Charter Medical take a collaborative, engineer-led approach to custom bioreactor design
Situation 
A global developer of biosimilar recombinant proteins used as active pharmaceutical ingredients (API) faced a critical issue with the film supplier for their single-use bioreactor. The dual-layer film was causing issues with the welds for the sparge assembly devices and other new technologies. Communication with the vendor was mainly through the sales representative, limiting collaboration with the engineering team and resulting in confusion and excessive delays.  

The client contacted Charter Medical for help and was immediately assigned a project management engineer who would be directly responsible for the design and specification review for their product. This open line of communication helped to streamline the development process.

Challenge
Charter Medical case study - customised bioreactor design
Custom designed bioreactor

The main challenge was to design a bag with a sparge assembly capable of different aeration rates required for various types of cells along with not having to anchor the assembly with sharp-edged polypropylene barbed connectors. Also, due to the client’s shortened timeline, Charter Medical needed to prioritise this project to meet their expectations for commercial launch. 

Actions
Charter Medical assembled a team comprised of engineering and R&D to investigate alternative designs. Several configurations were explored to determine the best way to anchor the sparge assembly in the bag. A change was made to moulded elbows and tees that were attached to ports welded to the inside bottom of the bag. The moulded elbows and tees eliminated the sharp edges on polypropylene barbed connectors. By not cutting holes in the film where the interior ports were welded, it allowed those ports to act as anchors for the entire sparge system and not affect airflow.                                                                                                                                       
Results
The unique configuration of the sparge assembly supported the delivery of a broad range of aeration rates accommodating both mammalian cultivation and low-density microbial fermentation. With this added flexibility the customer received a bag system they could use for different cell types as well as different applications. This helped to reduce the overall cost of their process and accelerated their time to market. The new bag was manufactured by Charter Medical and the client went on to commercialise their product.



If you have questions or would like to find out more about a customised design approach, get in touch with Byron Sample - Products Applications Manager at Charter Medical