Value Drivers and Benefits of Closed Processing
The biopharmaceutical industry is evolving rapidly as drug manufacturers manage increasingly complex product pipelines and seek production efficiencies to reduce time to market, increase flexibility, and decrease costs. Closed processing is one such strategy and key enabler that offers significant advantages for production of biopharmaceuticals in this changing environment.
What is closed processing?
A process step (or system) in which the product and product contact surfaces are not exposed to the immediate room environment. System closure can be defined and achieved in one of two ways.
Functionally Closed System
May be opened but rendered closed through a sanitization or sterilization step prior to processing. Once the system is rendered closed, transfer into or out of the system must be done in a closed manner, such as through an aseptic connection, filter, etc. A good example of a functionally closed system is a stainless-steel bioreactor, that is cleaned in place (CIP’ed) and steamed in place (SIP’ed) prior to processing.
Fully Closed System
Never opened or exposed to the environment. Materials added or removed from the system must be done in a closed manner, such as through an aseptic connection, filter, etc. Some processes may require closed and contained disconnection and disassembly. A good example of a fully closed system is a single-use assembly that comes pre-assembled, pre-sterilized, and is equipped with aseptic connectors.
It is important to note that closed processing does not equal sterility. It is a function of bioburden, cleanliness, and integrity. Some unit operations may require sterility, such as cell culture and final filling, whereas other unit operations may require low bioburden.
Primary Drivers and Benefits of Closed Processing
The adoption of closed processing is propelled by several well-defined drivers:
- Reduced risk of contamination
- Enables multi-product and multi-modal facilities
- Reduced gowning requirements and time savings
- Reduced environmental controls
To gain a better understanding of these drivers and the potential value for drug manufacturers, we compared a traditional single-use Monoclonal Antibody (mAb) batch process to a fully closed single-use mAb batch process, and quantified the percent change related to contamination risk, facility utilization, gowning, and environmental controls.
1. Reduced Risk of Contamination
Traditional biomanufacturing processes include some open manipulations, which put the process at risk of contamination, even when the operation is conducted inside of a classified cleanroom environment. Closed processing mitigates this risk by completely segregating and containing the process from the room environment. When systems are closed, the room environment and operators no longer pose a risk to the process, so environmental control, sampling, gowning, and room cleaning requirements can be reduced. This can result in significant energy, labor, and cost savings, in addition to simplification of facility infrastructure and floorplans.
With the growing adoption of intensified and longer duration continuous processing, contamination control and risk management become even more critical.
Bottom line: contamination risk can be reduced by moving to closed processing.
Overall, contamination risk is reduced by 47% when moving from traditional processing to closed processing.
2. Enables Multi-Product Manufacturing and Multi-Modal Facilities
With traditional manufacturing systems, producing multiple products in the same facility can be challenging and risky. Processes with open manipulations prevent drug manufacturers from performing concurrent manufacturing of different products and requires comprehensive, labor-intensive cleaning and sterilization procedures between product batches to prevent cross-contamination.
However, closed processing, by virtue of its sealed nature, allows for simultaneous manufacturing of multiple products. The more product that a facility produces, the lower their cost per gram. Even small increases in facility utilization can result in significant value to a drug manufacturer via higher throughput.
3. Reduced Gowning Requirements and Time Savings
In traditional processing, operators pose one of the largest risks of contamination to the process, even with the use of extensive gowning materials. They must go through a rigorous, time-consuming gowning procedure multiple times per shift to reduce the potential that they will introduce a contaminant to the process when performing a manual operation.
With closed processing systems, this risk is mitigated because the process is completely segregated from the operators. There is less need for stringent gowning, resulting in increased productivity and considerable cost and time savings.
Overall, it is estimated that closed processing can reduce gowning time by 55% and gowning costs by 81%.
4. Reduced Environmental Controls
Another pivotal factor that makes closed processing attractive is its ability to reduce energy consumption and the need for rigorous environmental monitoring.
Since traditional manufacturing systems require open manipulations, they are typically located in classified cleanroom environments. These rooms demand significant amounts of energy to achieve the required air exchanges and maintain stringent particulate levels. In contrast, closed systems, with their sealed nature, are used in environments with much less controls, thus consuming less energy and significantly reducing the need for environmental monitoring and testing.
The outcome is a twofold advantage: a decrease in operational costs and a step towards environmental sustainability. In essence, closed processing offers an efficient solution that benefits both businesses and the environment.
Energy consumption can be reduced by up to 65% and environmental monitoring can be reduced by up to 88% when using closed systems in conjunction with a ballroom concept.
Conclusion
From a financial perspective, closed processing presents an attractive proposition. Financial savings stem from lower risks of contamination, reduced environmental controls, and higher facility utilization. The initial investment required for setting up closed systems may be higher, but the cost efficiencies realized over time significantly outweigh the upfront costs.
Closed processing will continue to evolve within the biopharmaceutical manufacturing industry. It is a robust shift towards a future-ready approach, ushering in the era of bioprocessing 4.0 and creating the blueprint for the facility of the future. Advantages in using closed systems are numerous, with benefits extending beyond immediate financial gains and time efficiencies, and contributing substantially to overarching industry goals.
Ultimately, the future of bioprocessing lies not in isolated, traditional systems but in closed, connected, and continuous enabled processes.
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