Take the time to thoroughly evaluate your current process and identify potential bottlenecks or areas for improvement. Consider further factors that could come into play, such as material and size compatibility, process validation steps and supply chain risks. By planning ahead, you can minimise these risks and streamline the scale-up process.
1. Make a Plan
Starting with a plan may seem obvious advice, but in order to successfully scale-up your process it's crucial to have a plan in place from the very beginning. This starts with your initial small scale design where you consider options and select a design that allows for ease of scale-up later down the line.
Scaling up from development to pilot scale is often a move into clinical trials. Then those clinical trials scale up further when they prove to be successful. Therefore if you plan for success and you will be on the right track.
2. Choose the Right Equipment
Selecting the appropriate single-use equipment is essential for a successful scale-up. Ensure that the equipment you choose aligns with your specific process requirements and has been validated for use in similar applications.
Collaborate closely with your suppliers to understand their product offerings and seek their expertise in selecting the most suitable equipment for your needs.
3. Identify your Process Parameters
During single-use scale-up, it's important to identify and understand your key process parameters to maintain product quality and consistency. By conducting thorough testing at small scales, you can set out the key parameters such as temperature, pressure, mixing speed and flow rates that work best for your process. This then serves invaluable when scaling up to larger volumes.
4. Train Your Team
A well-trained team is crucial for successful single-use scale-up operations.
Provide comprehensive training sessions that cover not only the technical side of operating the equipment, but also safety protocols, quality standards and highlights steps for resolving issues, this in turn will help problem-solving during the scale-up process.
5. Validate Your Process
Process validation is an integral part of ensuring quality control during single-use scale-up. The full validation approaches for your single-use system depends on whether the system is standard or custom. It encompasses critical parameters such as
sterility assurance, integrity testing, extractables/leachables studies and compatibility testing.
This is achieved by carrying out and documenting all three phases of process validation: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) at each stage of the process.
6. Monitor Performance
Continuous monitoring of process performance is essential to identify any potential problems or issues that may arise during scale-up. Implement a comprehensive monitoring system that tracks key parameters in real-time, allowing you to make adjustments promptly. Regularly analyse data and compare it against your parameters to ensure product quality and consistency.
Automation can play a key role in monitoring your process and preparing it for scale up. Minimising user error, ensuring precise measurements and simplified data documentation.
This can be achieved using solutions such as Scilog pumps or metering systems for accurate filtration, metering and dispensing. Or accurate monitoring of temperature, conductivity or pressure with SciLog single-use sensors.
7. Speak to the experts
Talking with specialists in single-use can greatly enhance your chances of success during single-use scale-up. Whether you’re engaging with fellow colleagues or reaching out to your single-use solutions provider, they are an invaluable tool on hand for you. Utilise their knowledge and experience in scaling up similar processes and you’ll be on the right track.
With years of knowledge and experience, BioPharma Dynamics’ recommendations can help you navigate potential challenges and optimise your scale-up strategy.
Are you ready to take on the challenge of single use scale-up?
By following these seven tips, you can increase the success of your single-use scale-up strategy. Remember to plan ahead, select the right equipment, identify your process parameters, train your team, validate your process and monitor performance.
If you're looking for advice and solutions to aid your process at any stage of the single use scale up process, look no further than BioPharma Dynamics.
We are specialists in single-use with an extensive product portfolio, whilst our open architecture approach ensures you aren’t tied to any single manufacturer range of products. From initial concept to full-scale production, we provide solutions tailored to your exact needs and designed with scalability in mind. All handled end-to-end by our experts so you can focus on what you do best.
Our experienced team is ready to assist you every step of the way. To discuss how we can help optimise your process, contact us today!
