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You're facing quality control challenges in bioprocessing scale-up. How do you ensure smooth operations?

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Scaling up bioprocessing operations can be a daunting task, especially when it comes to maintaining stringent quality control measures. You might be familiar with the basics of biotechnology, but as you increase production, the complexity of ensuring product consistency and purity can escalate dramatically. Addressing these challenges requires a multifaceted approach, integrating robust quality control systems, advanced analytics, and meticulous process optimization. Let's explore some key strategies to help you navigate these waters and maintain smooth operations during bioprocessing scale-up.

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Paul Spencer, MBA, BSChemEng, PE, PMP

Problem resolution specialist with multiple contacts as clients and resources. Specialist in leading teams to success

1 Process Mapping

When scaling up your bioprocessing operations, the first step is to create a detailed process map. This will serve as a blueprint, identifying each stage of production, from raw material procurement to final product packaging. By understanding the flow of materials and information, you can pinpoint critical control points where quality issues are most likely to arise. This proactive approach allows you to implement targeted quality controls and streamline your process, ensuring each batch meets your high standards.

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Paul Spencer, MBA, BSChemEng, PE, PMP

Problem resolution specialist with multiple contacts as clients and resources. Specialist in leading teams to success
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Many scaleups result in significant improvements in the overall recovery of product. Downstream from chromatography and filtration operations are especially frequent improvement points. I have worked on several processes where a 6 fold increase in batch size resulted in a 10 fold increase in target product. Scale-Up of raw materials, buffers, and TFF components drastically changed sizes. That skill set requires experience and planning.

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2 Risk Assessment

A thorough risk assessment is vital in pinpointing potential quality control issues before they escalate. By evaluating each step of the bioprocessing workflow for risks such as contamination, equipment failure, or process deviations, you can prioritize areas that require stringent monitoring. Implementing a risk-based quality management system helps you focus resources effectively, ensuring that critical aspects of your process are under tight control as you scale up.

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Paul Spencer, MBA, BSChemEng, PE, PMP

Problem resolution specialist with multiple contacts as clients and resources. Specialist in leading teams to success
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One of the scaleup process concerns is chromatography resin overload. This can modify the protein profile of the elution solution. It is critical to know if the change in profile results in a change in final product or if an additional purification step is necessary.

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3 Analytical Tools

Leveraging advanced analytical tools is crucial for maintaining quality during scale-up. Techniques like high-performance liquid chromatography (HPLC) and mass spectrometry can provide detailed insights into the purity and composition of your bioproducts. Regular use of these tools throughout the production process allows for early detection of quality deviations, enabling prompt corrective actions and reducing the risk of large-scale product waste.

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4 Training Protocols

Investing in comprehensive training protocols for your team is essential for maintaining quality control during scale-up. As processes become more complex, the likelihood of human error increases. By providing ongoing education on best practices, standard operating procedures, and the proper use of equipment, you can minimize mistakes and ensure that every team member is a guardian of quality within your bioprocessing operations.

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Paul Spencer, MBA, BSChemEng, PE, PMP

Problem resolution specialist with multiple contacts as clients and resources. Specialist in leading teams to success
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Over the wall tech transfers, with no process development team members providing 10 batch run manufacturing support, are a common issue. Likewise, process development people that change an approved process are a concern. These are skills that are on the shoulders of Operations management. This is an area of weakness in many organizations.

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5 Continuous Monitoring

Continuous monitoring is the backbone of quality control in bioprocessing scale-up. Implementing real-time monitoring systems that track critical process parameters can help you maintain consistent product quality. These systems provide immediate feedback, allowing you to adjust conditions on the fly and prevent deviations from spiraling out of control. With a vigilant eye on every stage of production, you can assure that quality is never compromised.

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Paul Spencer, MBA, BSChemEng, PE, PMP

Problem resolution specialist with multiple contacts as clients and resources. Specialist in leading teams to success
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However, changes to approved process parameters need to have documented reasoning. The approved changes must include individuals that are familiar with the process steps and represent appropriate team members. Documenting the reasoning for the change, the options considered, and the results are critical.

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6 Feedback Loop

Establishing a robust feedback loop is key to ongoing quality control. By systematically collecting data on process performance and product quality, you can analyze trends and identify areas for improvement. This feedback enables you to refine your bioprocessing methods iteratively, adapting to new challenges as they arise and ensuring that your scale-up efforts lead to reliable, high-quality outcomes.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Paul Spencer, MBA, BSChemEng, PE, PMP

Problem resolution specialist with multiple contacts as clients and resources. Specialist in leading teams to success
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Scale-Up has part art and Part science. A great person skilled in these areas can often result in significant impacts to a site, division, or corporation. Scale-Up of the aeration process for mammalian cells versus roller bottles resulted in huge savings in the manufacture of red blood cell promoting medications.

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You're facing quality control challenges in bioprocessing scale-up. How do you ensure smooth operations?

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1 Process Mapping

2 Risk Assessment

3 Analytical Tools

4 Training Protocols

5 Continuous Monitoring

6 Feedback Loop

7 Here’s what else to consider

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