Batch versus Continuous Processes: The Future

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Batch versus Continuous Processes: The Future

The future of drug manufacturing has become a more prevalent conversation, especially during a time where new technology has arisen. According to Lawrence Yu, Ph.D., FDA’s Deputy Director for the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, a common process referred to as “batch” manufacturing, in biopharma processes, has existed for decades. Batch manufacturing is a process in which a series of steps are performed, including many stops and starts, with the result of a complete and finished product. This process of manufacturing can take months of production time, and days to weeks, alone, with just disassembling, cleaning, and reassembling the system. This can lead to drug shortages, and/or price increases of medicines that are in demand due to the constant need of these medicines. Not only does this become costly for the pharmaceutical company that is responsible for manufacturing the drug, but also for hospitals, or industries that need these drugs for business.

Continuous manufacturing allows for faster production, quicker clean-up, and an overall better turnaround time. There is virtually no need to stop and restart the same process, for the same drug, anymore. Continuous manufacturing is where a company uses a disposable product line, and system to manufacture pharmaceutical (but not limited to just pharma) companies’ products. When the process has completed, that company would simply remove the disposable liner, toss it, replace the old liner with a new liner, maybe do a quick steam-in-place (SIP), and start the next drug manufacturing process. Yu has stated, “In some cases, manufacturing that takes a month by batch technology might only take a day using continuous manufacturing techniques” (Yu, “Continuous Manufacturing Has a Strong Impact on Drug Quality”). This is crucial with the increasing demand for various medicines that can prompt a breakthrough in drug shortages, and a cost decline of currently expensive, life-critical medicines. Hypothetically stating, continuous manufacturing can serve as a win-win for every party involved in the pharmaceutical industry: from the manufacturers to end-users, as more people will be less apprehensive of buying medications, or being sparse with medication consumption due to costliness and trying to prolong their prescribed medications for as long as possible. If the prices are fair, people would be more so inclined to get hospital, or health care, ultimately leading to more demand for medicines from pharmaceutical manufacturers, and an overall boost in the economy, or simply to help with life-saving medications that have become sparse due to costliness.

continuous-pharma-manufacturing-1Not only does continuous manufacturing provide a solution to drug shortages and a solution to costly medicines, there’s also an added level of safety and sterility; Yu has stated that “…continuous manufacturing is more reliable — and safer. That’s a powerful combination” (Yu, “Continuous Manufacturing Has a Strong Impact on Drug Quality”). There are less chances of human error, or human contamination, with a continuous process because there is no need to stop and restart the same drug process every so often. Thus, leading to a purer drug because of the minimized human contact that batch manufacturing involves. Continuous Manufacturing also allows for ease in changes within sample medicines; resulting in a better, safer drug in a shorter amount of time. This can solve the issue of extensive drug test processes that may take months before finding the proper ingredients of life-dependent vaccines or medicines. A faster process ultimately calls for a quicker chance to find the correct solution that could save a life, in a timely manner. Or, it can simply solve the issue of unfortunate, and ill-prepared drug shortages, as it would take 30 times less manufacturing time to produce more drugs with continuous manufacturing than it would with batch manufacturing.

Many companies are switching over to continuous manufacturing technology as they can see the benefits outweigh the doubts and apprehension derived from the comfort of traditional stainless steel. Jill Wechsler, BioPharm International’s Washington Editor, wrote in her article, “Modern Manufacturing Comes to Age,” of the different companies who have followed the FDA’s advice on switching to continuous manufacturing technology, “Eli Lilly is investing in a CM operation in Cork, Ireland. Amgen has been shifting to more flexible production operations for its protein-based drugs for several years, most notably at a $200 million plant in Singapore that features modular designs and continuous processing.” These large companies have invested and trusted in continuous manufacturing technology because of the overall benefits, especially in the realms of long-term profit and solving the ultimate goal of the global drug shortage problem.

Continuous manufacturing is the future of bio-pharmaceutical processes.
ARTeSYN® Biosolutions will help you get there.

 

 

Sources: Wechsler, Jill. “Modern Manufacturing Comes of Age.” BioPharm International: Science & Business of Biopharmaceuticals June 2016: 8+. Print.

Yu, Lawrence, Ph.D. “Continuous Manufacturing Has a Strong Impact on Drug Quality.” FDA Voice. U.S. Food and Drug Administration, 12 Apr. 2016. Web. 05 Oct. 2016.

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