Digital transformation in biopharma promises to deliver exponential results and make new discoveries and solutions to complex problems a reality, but it requires companies to make big changes to get there—changes in processes as well as adoption of new technologies. For some companies and facilities, this is a bigger leap than for others. Depending on the level of digitalization and integration that currently exists within a company, the process can take from months to years.
Digital transformation in biopharma, like other industries, is accelerating as Pharma 4.0 and Industry 4.0 begin to take shape in companies of all sizes. But knowing that digital transformation is inevitable is one thing, successfully managing the transition process is another. What are the steps biopharma companies should be taking to ensure a smooth digital transformation?
Looking for ways to improve the efficiency of its power plant operations while reducing costs and environmental emissions, the Department of Power and Water at Michigan State University (MSU) began a study using multivariate data analytics that led to some surprising findings. The results have implications that could help other operators of large-scale power facilities reduce their carbon footprint and improve power plant operations.
Finding the right balance between efficient power output from boilers and other energy producing equipment while also reducing environmental emissions is an important objective for power plant operators. Governments and environmental agencies around the world establish emission standards as part of air pollution regulations, but finding the right way to meet the standards can vary greatly depending on location, equipment and other operating factors.
From employing artificial intelligence (AI) to identify drug candidates to using big data to support continuous process manufacturing, the prospects for digital transformation in the biopharma industry are huge. Yet, biopharma and life sciences lag behind many other industries when it comes to digital transformation.
In the midst of a global crisis, many industrial manufacturing operations— including those in the chemical industry— are faced with shortages of supplies and equipment, or staff reductions, and finding it difficult to keep operations working as normal. Are there process improvements or tools that can be used to manage production more efficiently during this time of COVID-19 (and moving forward)?
While many other industries have implemented multivariate data analysis software for process optimization and control, it is still not very common in the pulp and paper industry. However, multivariate data analysis has a very promising potential for both cost reductions and quality improvements in pulp and paper mills. No capital investments are needed, the implementation can be done remotely, and the software typically requires no permits.
A team at Glaxo Smith Kline, GSK, has carried out several studies using Raman spectroscopy and multivariate data analytics in order to monitor upstream cell culture processes. The studies show that Raman spectroscopy is a valuable analytical tool for enabling real-time monitoring and control of production bioreactors and that improved control can lead to improved product quality. Below is a summary of the studies.
An important step on the road to creating treatments for illnesses like COVID-19, which has caused the recent global pandemic, may start with understanding the similarities and differences between the various strains of coronavirus known to exist today. Making sense of large and complex sets of data, especially those that require novel interpretation, calls for a powerful analytics toolset to speed up the process.
Out of control processes in pharma manufacturing are not something to take lightly. If your production runs are seeing frequent deviations, leading to expensive batch losses or frequent rework, it’s time to take a look at ways to correct any process deviations in a more expedient manner. Uncorrected deviations or processes that vary from approved process parameters can lead to costly and dangerous mistakes.
Keeping your pharmaceutical manufacturing processes under control is important not only to ensure a quality product, but also for regulatory compliance. Process or raw material deviations can affect the downstream quality of a product and could mean tossing out an entire batch or end product if process corrections aren’t made soon enough — or if you can’t document that a correction was made before it affected your critical quality attributes.
For pharmaceutical manufacturers, a process deviation may not only mean a bad batch that affects a downstream process, it can also risk a regulatory violation that leads to fines or expensive market setback, or worse, it could endanger the health of the patient.