In the last few years, many pharmaceutical companies have started investing in continuous production, and some have already succeeded in filing new pharmaceuticals using a continuous flow manufacturing process. This article summarizes a study at GlaxoSmithKline, GSK, where real-time multivariate monitoring added value to the development of a continuous production process of an active pharmaceutical ingredient (API).
The pharmaceutical industry, including R&D, manufacturing and also product sales and use, creates a lot of data. The question is, what can we do to understand our data better, get more out of it, and unlock its potential in the most rational way possible to get to the knowledge we need? And how can we gain control over our research, or the processes needed to generate a stable, reliable product that consistently meets regulatory requirements? The answer is Multivariate Data Analysis.
The 2019 Umetrics User Meeting drew more than 102 engineers, operations managers, process experts, researchers, and data scientists in industries ranging from biopharma to food and beverage to chemicals who gathered to share ideas and insights into new methods for streamlining their processes, reducing waste and cost of goods sold.
Injection molding is the most important production method for manufacturing plastic components used in products ranging from cars to medical devices. Although the plastic components themselves are often inexpensive to produce, any defect can lead to expensive errors that can affect the performance or safety of the finished product. Creating a system of early fault detection and continuous process improvement can mean big payoffs for manufacturers.
Consumers expect a certain consistency in quality and taste from the food and beverage brands they love. But many factors can influence the way a product tastes when it reaches the consumer – ranging from the manufacturing process to seasonality of ingredients to storage temperatures. Similarly, a number of other factors may influence the overall quality attributes that matter, such as alcohol content of beer or stability of the whiskey aging process.
The natural variability of botanical material often makes it difficult to ensure a consistent quality process for pharmaceuticals made from plant-based products. In addition, botanical drug products (BDPs) are often produced using a series of separate batch processes, which adds even more variability into the manufacturing process.
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 production, your media will pass several different refinement steps. To really understand and be assured about a good progression and state of the production, all of these processing steps need to be monitored continuously. With SIMCA® and SIMCA®-online, both part of the Umetrics® Suite of Data Analytics Solutions, you can confidently monitor and control every step of your process. The web clients allow you to access manufacturing data anytime, anywhere.
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.
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.