Taking steps to understand and control process variation is crucial to biopharmaceutical manufacturers. The sentiment behind the old adage, "the product is the process" can’t be dismissed.
Any uncontrolled variation in the manufacturing process can lead to a finished product that potentially behaves differently to its performance in clinical trials, such as an alteration in glycosylation profiles affecting the half-life of the molecule. This will result in negative implications for the patient, drug supply, revenue, and the ability of biopharmaceutical manufacturers to serve their markets.
How can automated single-use technology support biopharmaceutical manufacturers in reducing process variation?
Put simply, single-use automation helps by increasing process consistency and eliminating variation derived from operational and environmental inputs, while also reducing the opportunity for error. It can also have a positive impact on the following sources of process variation:
Biological
Selecting the right cell line early in the development process is clearly vitally important, but product variability can also be reduced by optimizing and then controlling process parameters during cell culture.
Raw materials and consumables
Single-use technology has introduced a greater range of product contact materials. This increases the importance of single-use suppliers controlling their own supply chain to ensure the products used are consistent and meet the regulatory and process requirements.
Operational inputs
Humans don't always perform tasks the same way in a manufacturing environment. Tasks such as how equipment is assembled and how unit steps are conducted when manual processes are transferred between facilities can result in process variation. Automation of these manual operations can help to counter these challenges by detecting and controlling variation.
Environmental factors
A closed single-use system can help to eliminate contamination and operator exposure risks. Automation can provide standardization from start to finish, giving control, monitoring and feedback on parameters such as pressure, conductivity and temperature.
Case study: Automated filtration and dispense system
A manufacturer of a potent biologic product wished to automate and enclose a labour-intensive bulk filling process that was highly manual and prone to human error.
The challenges
- The need to divide the product into smaller bottles and bags to allow for easier shipping and minimize the risk of loss of highly valuable product (through leaks) during transportation.
- The lack of a standard process or procedure for sterile filtration and filling meant that there were no standard consumables available within the customer’s supply chain and the process needed to be planned in advance to ensure the consumables were on site and staff were trained in the process.
- The need for full containment and automation to minimize the risk of operator exposure to the product.
The solution
To meet these challenges Parker domnick hunter introduced the SciLog® Filter and Dispense System, an automated bulk filling system based on single-use process automation and single-use assemblies.
The system has the ability to dispense a large quantity of product to either bottles or bags connected to a single-use manifold which has been gamma-irradiated. Once filled, the bottles or bags can be disconnected and sealed aseptically, ready for freezing and shipment.
The SciLog® Filter and Dispense System follows a 10 step process (right). Watch this animated demo of the system to find out more.
What did it achieve?
- Sterility of the final dispensed product by passing the process solution through a sterilizing grade filter.
- High accuracy of dispensing solutions and products due to its weight-based feedback system.
- Accurate labeling of containers before removal from the system via an integrated printer.
- Straightforward implementation of repeatable and robust procedures based on pre-configured recipes enabled by a PLC-based system.
- Error prevention through a bar code system that does not allow the operation to start until the correct manifold and bar-code combination is installed.
Results
Two sources of variation were dramatically reduced as a result of the introduction of SciLog® Filter and Dispense System.
Operational variability was reduced by:
- Automating the ten step process
- Standardizing the filtration and dispensing operations between, operators, batches, and campaign
- Increasing dispensing accuracy
Environmental variability was reduced by:
- Eliminating the need for a vertical, laminar flow hood
- Minimizing the process time ensuring the product is not exposed to temperature fluctuation
- Enclosing the system for filtration and dispense of bulk process solutions, protecting both operator and process
This post was contributed by Graeme Proctor, product manager, single-use technologies, Parker Bioscience Division, United Kingdom
Parker Bioscience Division specializes in automating and controlling single-use bioprocesses. By integrating sensory and automation technology into a process, a manufacturer can control the fluid more effectively, ensuring the quality of the final product. To find out more visit www.parker.com/bioscience
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