Advancements in cell and gene therapy hold promise for the future of personalized medicine, especially for cancer treatments. However, bioprocessing methods for autologous cellular therapies, and CAR-T in particular, often present unique challenges in manufacturing due to the variability of the starting material and unique nature of each batch. Is there a way to create more efficient processes in order to bring down costs and make personalized medicine a viable option for more patients?
In a manufacturing setting where consistent quality matters, variability in how individual technicians and operators perform their jobs can be frustrating for managers. Companies need a way to achieve consistent quality, without reducing the capacity for innovation and improvement.
You may have heard the term Six Sigma used in conjunction with lean manufacturing, a Kaizen approach or continuous quality improvement. Perhaps you thought Six Sigma only applied to large-scale business operations, or that newer philosophies had overtaken Six Sigma as the most updated approach to quality management? But if you're looking for a way to improve your production processes or solve a problem you’re having with quality, Six Sigma might be the answer. Are you and your team familiar with these concepts? Here's an overview.
In bioprocessing today, a shift is happening that takes the ability to monitor, optimize and control processes to the next level. Whereas in the past manufacturers aspired to measure data in order to find out why a bioprocess action happened (using descriptive and diagnostic analytics), today we are able to use predictive analytics to determine what will happen in a bioprocess based on specific process data measured in real-time. This migration “up the food chain” to a higher level of data analytics requires automation, ongoing process monitoring and the ability to make adjustments in real-time.
For manufacturing companies, process control is essential— even for those producing low-cost items such as small plastic parts. That’s because even when units are small and inexpensive, the cost of defects becomes exponentially higher when they reach the next manufacturing step at another plant.
In manufacturing and other industries that have complex processes, knowing which variables have the most impact on quality and at what point, or knowing which combination of variables to change in order to improve your process, can have a huge impact on the overall quality or profitability of your manufacturing process. But without making expensive and time-consuming changes in the physical processes in order to test all possible scenarios, how can you identify and predict the variables that have the most significant impact on your outputs?
Using real-time data analytics monitoring has become the accepted way to monitor processes in several industries. The goal is to detect and diagnose issues as they happen, which is a great leap forward compared to traditional analysis conducted in retrospect. This has been highlighted in a previous blog post.
Using a Quality by Design (QbD) approach for DOE supports ICH Q8 compliance
In pharmaceutical development, manufacturers must be able to demonstrate product robustness and deliver the intended quality of the product within allowable ranges for the claimed shelf-life period. Both international and country specific regulatory agencies, such as the FDA, pay close attention to these claims.