After all the disruption of the past year, new work paradigms are emerging for biopharmaceutical manufacturing. Fueled in part by the accelerated development and production of COVID-19 vaccines and therapeutics and by the crises caused by the pandemic itself, these changes represent both challenges and opportunities.
Although no one can say with absolute certainty what manufacturing processes will look like in the post-pandemic environment, there are signals pointing to where pharmaceutical firms need to be directing their attention. We must remember that normal was the past and that the new normal is where we want to be. We should prepare accordingly. To move forward successfully, biopharmaceutical companies will need to take the following actions.
Build flexibility into supply chains
Shutdowns caused by the pandemic exposed vulnerabilities in supplier networks, and many in the biopharmaceutical industry had difficulty procuring the raw materials and equipment that keep operations up and running. In such instances, the most obvious remedy is to increase inventory, especially for products that are rare or commonly in short supply.
But stockpiling is not always practical, or even possible. That is why it is also critical for biomanufacturers to take a step back, review their supplier ecosystem as a whole, and identify where it is feasible to build in flexibility and redundancies.
In addition, at the height of the lockdowns, when so many were operating under supply-limited conditions, personal relationships across the supply chain and with the other manufacturers proved essential. This kind of old-school networking enabled the sharing of not only information, but also equipment and supplies. So, turn fresh eyes toward your supplier networks, check inventory levels, and revise them where necessary—and do not underestimate the value of personal connections throughout the industry.
Design resilient manufacturing processes
Since supply chain disruptions were so common over the past year, some manufacturers decided to use innovation to make up for shortfalls. For instance, when one company was low on the filtration membranes needed for purification of their biologic products, engineers there reexamined the process and found a clever way to reduce the need for new membranes, without impacting QA/QC standards. Examples like this illustrate how returning to fundamentals can uncover opportunities to create bioprocesses that are more adaptable and resilient.
Embrace new bioprocessing modalities
For years now, there has been movement away from traditional bioprocessing routines and toward new modalities for processing such as cell-free systems, continuous manufacturing, and microfluidics, as well as for products such as messenger RNA, gene therapy, and genome editing. That movement is now being accelerated by the successful development and production of COVID-19 vaccines and therapeutics, as well as by promising data from other clinical trials.
As evidence of successful applications accumulates, next-generation modalities will continue to allow manufacturers to expand their pipelines and, in some cases, reimagine how certain drugs are produced.
Prioritize the health and safety of the workforce
The pandemic put the spotlight on the human element of biopharmaceutical manufacturing like never before. To be blunt, manufacturers were reminded that without the people in their plants, there is no product produced. Organizational management strategies shifted to reduce the number of employees on the floor and ensure that anyone who is working is properly trained in COVID-19 procedures and equipped with the appropriate personal protective equipment (PPE).
Ensuring workplace safety, demonstrating viral clearance, and maintaining the integrity of processes in general have always been top concerns in the industry, but there is no doubt that these matters took on new and vivid meaning over the past year, inspiring changes to organizational management tactics that will create more robust operations going forward.
Incorporate ML and AI
Machine learning (ML) and artificial intelligence (AI) can help with every category mentioned above. For example, manufacturers can use ML-augmented applications to remotely monitor equipment, reducing the need for human interventions and mitigating risks for employees. At the extreme, current and new sensor technologies and analytics could be used to create digital representations (sometimes called “digital twins”) of machines or systems which can serve as models to test and optimize manufacturing processes and conditions.
Leading pharmaceutical firms are already deploying other forms of ML, such as robotic process automation (RPA), for supply chain rebalancing and other business operations that can maintain workflows and improve efficiencies.
As the biopharmaceutical industry and the global economy overall move beyond the turmoil and uncertainty of 2020, manufacturers need to evaluate the lessons they have learned and determine how they can best position themselves for the future. New technologies and approaches will continue to evolve, but the marketplace will undoubtedly demand safety, flexibility, and resilience long after the pandemic ends.
Charles L. Cooney, PhD, is Robert T. Haslam Professor Emeritus of Chemical Engineering at MIT and lead instructor of the MIT Professional Education course, “Downstream Processing.” Online profile