Continuous manufacturing is one of the key trends within the pharmaceutical industry, both for the production of ‘classical’ drugs as well as large molecules. Companies are looking for ways to shift from traditional batch processing to a continuous method of operation. The main advantages associated with these processes are more room for modularity, automation and flexibility due to a smaller footprint, as well as more consistent quality of the drug product.
For pharmaceutical companies facing challenges such as rising costs, sterner regulations and declining profit margins, innovative new technologies like artificial intelligence (AI) and digital twins have become part of an essential strategy to future-proof their businesses. A digital twin is the next evolution of machine learning combining advanced data analytics and equipment simulation with comprehensive system models that blend historical information with real-time data to predict the future of a process. According to Gartner, the digital twin concept was one of the top 10 strategic technology trends in 2019.
There is a strong demand for devices such as mobile phones, tablets and large screen TVs all over the globe. The business is competitive, which puts pressure on prices. At the same time, production costs are fairly high due to complex production processes. Consequently, a high yield becomes paramount for good profit margins. Multivariate data analysis (MVDA) is being employed by an increasing number of manufacturing companies to increase yield, and the electronics industry is no exception. This article provides examples of where and how real-time data analytics can be used in the electronics industry.
Most biopharma manufacturing companies are keen to adopt new methods that would streamline production, reduce errors and ensure product quality. That was the goal of Bristol-Myers Squibb when they implemented a complex real-time process monitoring system that involved integrating data from a number of different technologies, systems and vendors to gain greater control over complex batch processes.
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.
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?