In many manufacturing industries, variability in raw materials can lead to unexpected and undesirable changes in the final products. In regulated industries such as pharmaceuticals, this is especially problematic due to the need to maintain carefully controlled processes that stay within approved regulatory parameters for drug development and production. Embracing a total company-wide digital transformation enabled Amgen to align data across multiple systems to not only control, but also predict unacceptable deviations in time to make necessary adjustments. Read on to find out how they used data analytics to implement real-time process control.
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.
Recently the FDA issued a new draft guideline for continuous manufacturing of small molecule drugs. With these draft guidelines the FDA wants to engage more pharmaceutical manufacturers to shift from traditional batch/start-stop processing to continuous manufacturing. The main advantages associated with these processes are more room for modularity, automation and flexibility due to a smaller footprint, but also more consistent quality of the drug product. Of course the main incentive for the FDA to promote this way of processing is that it believes that this will have a positive impact on drug prices and prevent drug shortages.
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.
Throughout the evolution of manufacturing, many industries have gradually shifted away from batch process to continuous process manufacturing as production technologies matured. This has included industries such as chemical, petroleum, steel, automobile, consumer goods and food manufacturing.