The world massively relies on the developments that continue to take place in the pharmaceutical industry to experience an improved quality of life. From producing drugs for rare forms of cancer to generating highly effective vaccinations for various epidemics and pandemics, this industry has always played a pivotal role in safeguarding public health. Its response to COVID-19 in particular underscores its potential to effectively address every global health crisis and mitigate long-term health risks associated with them.
The pharma industry has undergone a monumental transformation over the last few years. One of the major factors responsible for its transformative journey has been Process Intensification (PI). Driven by the need to increase efficiency, reduce cost, and improve product quality, it has been at the core of pharma manufacturing. At the moment, it is being majorly applied in bioprocessing and small-molecule drug facilities through Continuous Manufacturing (CM) for rapid development of new therapies and to scale up the production of existing drugs in order to evade a health crisis.
Continuous manufacturing and its benefits
There are three different approaches to continuous manufacturing; fully end-to-end continuous, a hybrid of batch and continuous, and individual continuous operations retrofitted in a batch process (mostly for legacy processes). The selection of any of these approaches is guided by factors such as enterprise readiness, the product itself, processes involved, equipment, relevant regulations, available technology, demand in the market, and volume/value of the product. Irrespective of the approach, integration of CM in the pharma sector results in smaller factories, better process control, and environmental footprints, lower capital input, consistent product quality, modular manufacturing, and lower operating costs.
As per a report by Straits Research, a market research company, the global continuous manufacturing market was valued at USD 504.25 million in 2022 and is predicted to reach USD 1,4290.95 million by 2031, registering a CAGR of 12.2 per cent during the forecast period. It also highlights that with more and more manufacturers realising the number of benefits CM holds, there’s a noteworthy increase in the investments in the R&D area, further leading to such positive predictions.
Out of many, one huge advantage is how CM renders drug sponsors the ability to rapidly respond to market opportunities. It can seamlessly accommodate scale-up and post-approval changes. For example, increases in lot sizes are possible by simply running longer. This can be particularly beneficial during drug shortages and competitive market situations, as manufacturers can acquire additional market share immediately with little to no disruption in operations or product quality.
Need for regulatory compliance and subsequent positive outcomes
Along with availing benefits of continuous manufacturing, manufacturers must maintain regulatory compliance to ensure public health safety, build trust, and ethically run the business. They can do so by following the guidelines of the FDA (Food and Drug Administration) and EMA (European Medicine Agency). Also, to establish a sense of transparency, especially for audits, and adhere to regulatory standards, manufacturers must have a Quality Management System (QMS) in place. This system assists in proper documentation and record-keeping.
However, some manufacturers have been hesitant to adopt CM due to perceptions of increased regulatory risks. They are primarily concerned about potential pre-market delays, greater inspectional scrutiny, and post-market hurdles. Nonetheless, a recent FDA self-audit comparing CM to batch manufacturing regulatory outcomes confirmed that manufacturers who submitted CM applications actually “had relatively shorter times to approval and market as compared to similar batch applications…translating to an estimated $171-537M in early revenue benefit.” In addition, the assessment displayed “no substantial regulatory barriers” for CM applications related to manufacturing process changes or pre-approval inspections.
Over the last decade, companies like Pfizer, Eli Lilly, GlaxoSmithKline, and others have proven CM’s commercial success, which is also indicative of the kind of potential this process holds to drive future trends in pharma manufacturing. Over a half-dozen medicines have already been made by using CM and have been approved in the U.S.
Along with this, semi-continuous manufacturing is also growing in popularity. This technique combines the elements of both – batch manufacturing and continuous manufacturing. As a result, certain stages of the process are operated continuously, while others are carried out in batches. Nonetheless, CM continues to remain a popular choice.
The way forward
Given the recent technological advancements, regulatory developments, and commercial products, continuous manufacturing is registering noteworthy growth in the pharmaceutical industry. Regulators are also pushing CM along with harmonised guidance development to ensure maximum clarity regarding various approaches and concepts associated with it.
But just like the two sides of a coin, along with CM’s success and growth rate, the challenges associated with it demand equal attention. Manufacturers are facing economic and workforce capacity challenges associated with CM start-up activities, upfront investment costs, and regulatory uncertainties in certain geographies. Therefore, to successfully implement CM in every pharma manufacturing facility, the key focus should be key investments, advancing scientific and technical knowledge, and additional incentives.
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