In response to COVID-19, the global industrial landscape is changing; and, of all the industries deemed to be “essential,” perhaps none is more important at this time than the drug production sector. Of course, a huge amount of time and effort is being spent on discovering and developing a vaccine against Sars-CoV-2; but, at the same time, the world’s patients still depend on their regular medications and prescriptions, the vast majority of which are oral solid dosage forms.

Traditionally, the pharmaceutical industry has relied on batch manufacturing processes to produce tablets and capsules — a complex procedure that requires large, dedicated manufacturing facilities. Taking inspiration from other sectors, GEA has pioneered the design, build and implementation of continuous manufacturing (CM) solutions to complement and, sometimes, replace these systems. During CM, material is simultaneously charged and discharged from the process to meet demands for faster product development, reduced costs, improved production economics and increased manufacturing flexibility.

The technology enables manufacturers to improve in-product quality in an efficient and cost-effective way and to comply with the increasingly stringent acceptance criteria put in place by the regulatory authorities. Additional benefits include increased OEE, optimized R&D, faster throughput, less waste, flexible batch sizes and reduced cleaning costs and materials.
For decades, however, the batch production of blockbuster solid dosage forms dominated the industry. Profitability was such that companies were not incentivized to innovate or risk developing new manufacturing technology. In the post-blockbuster era, however, it is increasingly recognized that material costs during drug development are significant, new drug products are likely to be manufactured in much smaller quantities and that, for novel treatments, the development of a bespoke commercial manufacturing process is not guaranteed.

Such pressures have put the costs, risks and timelines associated with traditional batch-based development and manufacturing under scrutiny. Plus, regulators are increasingly supportive of CM and manufacturers are realizing that current quality assurance costs are disproportionately large compared with other industries, wherein the production, detection and removal of out-of-specification product is vanishingly small.

Yet, despite agency support and the mounting body of evidence in favor of CM, doubts remain. Questions are frequently asked about CM’s ability to handle anything but large volumes of low-cost drugs, the finances involved in purchasing and installing appropriate equipment, whether regulators can keep up with the technical developments in continuous processing and, perhaps most poignantly, whether the conservative pharmaceutical manufacturing industry will grasp the nettle and appreciate the full benefits of “going conti.”

Some companies, perhaps, lacked the agility or capability to adopt CM, seeing it has a “nice to have” option but not an essential component of their manufacturing infrastructure. Many batch systems are perfectly adequate and have been in constant use for years. It’s too expensive, some say, too complicated. COVID-19, for good or ill, has now altered some of that thinking. Acting as a catalyst of change, drug producers all over the world now have a better understanding of the need to react quickly, manufacture safe, efficacious and high quality therapies in the shortest possible timeframes and meet the unmet needs of vulnerable patients. Time to market is critical.

The focus has shifted. It’s no longer an issue of whether it can be done. It must be done. Time for change. Irrespective of the end product, from over-the-counter medicines and generics to novel formulations, the time for continuous manufacturing is now.

Industry 4.0 compatible

Concomitantly, the pharmaceutical manufacturing landscape is evolving as never before. Much of this change is being driven by greater connectivity and Industry 4.0 — the fourth industrial revolution. ConsiGma^® 4.0 is ready for the industrial Internet of Things (IIoT). The ability to gather and analyze data in real-time results in faster and more efficient manufacturing processes that produce higher-quality goods at a reduced cost.

Additional benefits include greater supply chain transparency and just-in-time manufacturing practices that, combined with digitalization and higher levels of automation, meet the industry’s requirements for shorter development times and product lifecycle management. The in-process control of critical quality attributes (CQAs) and real-time feedback delivered by continuous manufacturing technology is no longer optional, it’s an imperative. Speed to market has never been more important.