What would you do with $1 million a day? That's how much pharmaceutical companies stand to lose during the drug development process, so they truly need to make every second count. Traditionally, the pharmaceutical industry has been batch oriented. While reliable, batch processing drugs can be a slow process with a higher risk for contamination/human error in between steps. Petter Mörée, Industry Principal for Pharmaceuticals, Food, and Beverage at OSIsoft, believes that for some firms, there may be a better way.
Petter has extensive experience in the life sciences, chemicals, and food and beverage fields, with a strong background in process chemistry with a specialization in chemometrics and data science. We sat down with Petter to ask him questions about the latest pharma innovations and trends such as moving from batch to continuous manufacturing.
What changes are being made?
While many drug manufacturers continue to use batch manufacturing to produce products, many are making the switch to continuous manufacturing, in which inputs are continuously fed in as products are continuously put out. Continuous manufacturing often allows for greater production volume, as there's no need to stop every time a product is produced to create a new batch.
Why does it matter?
In layman's terms, it means a shorter time to market, increased productivity, and a lower overall cost of operations. Since there is increased output with less capital investment, it means that companies can get drugs to market faster. There's also less energy and water consumption required as opposed to batch manufacturing, which means a smaller environmental footprint. Lastly, from an asset perspective, less machinery is needed in a continuous manufacturing line because of the amplified output. In an industry where it costs an average of $2.5 billion and 12 years to develop and get approval for a new drug, the smallest time and cost savings have massive impact on both the company's bottom line and the patient's health.
What are the challenges?
While switching from batch to continuous manufacturing may seem like an obvious solution to an industry-wide problem, there are a number of considerations that manufacturers need to take into account. First and foremost, not all products are well-suited for continuous manufacturing because of the required chemical reactions. The same goes for systems that have been built for batch production. Additionally, regulations in the industry are largely based around batch manufacturing, with most legislation based on individual batches, which are much simpler to track. When it comes to continuous manufacturing, the constant flow of materials can make it difficult to track deviations, given the dynamic calculations required. Whereas in batch manufacturing you can control static terms, an entirely different approach is required to make changes in the continuous manufacturing process, which can often mean seeking out entirely new systems/vendors; a costly and risky undertaking. Lastly, knowledge/awareness of continuous manufacturing is still limited, making implementations even trickier.
Who's done it?
Despite the challenges, there many companies have successfully moved from batch to continuous manufacturing and are having amazing results. Pfizer implemented continuous manufacturing in conjunction with batch manufacturing processes, taking bottleneck processes such as tablet coating and making them continuous rather than batch. Switching key processes over to continuous manufacturing has allowed for better overall machine and plant utilization, all while producing more product. J&J has cut production time of its HIV drug Prezista from two weeks to three days by implementing continuous manufacturing in production. UK-based firm Arcinova was able to improve the yield of a key drug component 10 fold, while improving purity from 85% to 97%. Merck is using the PI System in conjunction with Seeq technologies to support their transition from batch to continuous manufacturing, easing scale up challenges with the goal of bringing new products to market faster.
Despite the challenges surrounding continuous manufacturing, there's massive potential for producing higher quality drugs in greater quantities, faster than ever before. While not all processes and drugs are suited to a continuous model, those that are can reap massive rewards and ultimately pass that benefit along to the patients. OSIsoft is proud to be a partner of 24 of the top 25 pharmaceutical companies, all of whom rely on the PI System to reduce costs, improve productivity, and sustain innovation.
Learn more about OSIsoft's PI System and the pharmaceutical industry here.
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