A single-use processing systems are created for single usage and is becoming the primary approach for the manufacturing of biopharmaceutical products before being sold. The “plug-and-play” approach for single-use processing systems increases the inclination to using polymer raw materials as a contributing factor for the success rate of different companies using this bioprocessing system. Furthermore, single-use processing reduces the risk of any cross-contamination during processing, increases cost-effectiveness and reduces the floor space required for the growth of a bioprocessing market.
In recent years, the pharmaceutical industry has seen an increase in the use of single-use bioprocessing materials. The expiry of patents for blockbuster molecules and the use of potential products has resulted in some pharmaceutical companies using the single-use bioprocessing systems. There are various reasons why companies would use these techniques, including the issues listed below:
1. Cost Reduction
One of the advantages to using a single-use bioprocessing material in the pharmaceutical industry is the reduced cost for production. This reduced cost is associated with maintenance of the bioreactor systems, cleaning of the steel bioreactor systems and sterilisation of the systems. This is the core issue and explains the growth of the single-use bioprocessing industry as an initial investment. The R&D costs required during this manufacturing procedure are also dramatically reduced.
2. Increase In Material Productivity
Another advantage to single-use bioprocessing systems is the increase in productivity. This increase is due to a reduction in manufacturing costs and simpler automation approaches. Furthermore, the use for constant sterilisation is removed. It allows full-scale manufacturing as the cost of chemicals and water is reduced in single-use systems as compared to the conventional steel hardware systems.
3. Time-Saving Approaches
A significant element of single-use bioprocessing techniques is the quick manufacturing and reduced floor space being used in the co-affinity purification process. This reduces the amount of time employees spend on set-up, preparation, documentation and validation. Single-use bioreactors also offer flexibility in production, the initiation of multi-drug facilities, and meeting the demand of pharmaceutical production by a single manufacturer.
4. Ease Of Product Disposal
The primary difference between commercial products and single-use bioprocessing products involves the ease of disposal. Single-use systems are simpler, safer and easier to clean. Furthermore, the single-use bioprocessing production removes the potential of batch contamination using a cross-contamination operation. As these single-use systems are disposable, they no longer need to be sanitised and all materials during manufacturing can be easily disposed of following use.
5. Reduced Energy And Water Consumption
Utilising the single-use bioprocessing system can reduce the water and energy consumption during manufacturing. As the system is disposable, less water and energy is needed to clean the manufacturing equipment.
6. Reduced Risk Of Cross-Contamination
Two of the most significant concerns for any biomanufacturer is high expenditure on pharmaceutical material and potential cross-contamination. The use of single-use bioprocessing systems can remove these concerns. Three types of contamination can occur during processing including cross-contamination, biologic contamination and microbial contamination. Contamination of batches can reduce the level of productivity discarding and replacing materials after each batch; thereby increasing the likelihood of cross-contamination.