Innovation and sustainability go hand in hand in pharmaceutical manufacturing

With support from their global regulatory bodies, more pharmaceutical manufacturers are embracing digital technology. As they strive to operate more efficiently and sustainably, they also are accelerating healthcare innovation to save more lives.

At the end of 2018, scientists at the University of Edinburgh’s Roslin Institute confirmed that they had bred genetically modified chickens that produce eggs packed with proteins widely used in drug discovery and biotechnology. The process is 100 times more economical than producing the proteins in factories – and it is more sustainable, too.

While the researchers face years of work before the process can produce medicines for human use – just gaining regulatory approval could take decades – they said the study provides a “promising proof of concept” that could lead the way to more efficient drug production.

The Roslin project is just one example of innovative research focused on accelerating the process of inventing and developing new drugs. With a growing world population, aging demographic and the rising prevalence of chronic diseases, pharmaceutical companies are under intense pressure to find more treatments more quickly and increase drug yields and quality, all while reining in the high cost of drug discovery and reducing its environmental impact.

That’s a lot to juggle all at once, but Daniel Matlis, president of Life Sciences industry analyst firm Axendia, believes that focusing on innovation and sustainability is a powerful combination to drive competitive differentiation in life sciences.

“There are opportunities to manage cost while improving outcomes when you are green,” he said. “If you approach innovation and sustainability initiatives in a positive manner, by looking for ways to do good for your patients, your employees and for the environment, and do well for constituents and shareholders by improving value, that’s when you see companies achieving the best results.”

SUSTAINABILITY DEFINED

Each year, Corporate Knights publishes its Global 100 index, a ranking of the world’s most sustainable companies. Companies are judged on numerous criteria, including renewable energy use, waste production and supply chain sustainability.

In a nutshell, a sustainable company is “one that balances its pursuit for profits with responsibility toward human life, society and the environment,” said Michael Yow, director of research at the Toronto-based media and investment advisory firm.

In 2019, for example, Japanese biopharmaceutical company Takeda made the list for the fourth consecutive year.

“As a patient-centric, global, valuesbased, R&D-driven biopharmaceutical company and responsible global corporate citizen, our charge naturally extends from life-changing medicines to building sustainable value,” Christophe Weber, company president and CEO, said when the award was announced. Among other sustainability achievements, Corporate Knights recognized Takeda for performing in the top 25% of all companies for innovation capacity.

DIGITAL PROGRESS

For many such companies, advanced technology developments in the fields of scientific modeling and simulation hold the promise of accelerating discovery for drugs, vaccines, medical devices and more while also improving manufacturing efficiency.

In the life sciences, simulations are becoming an increasingly powerful option for testing new drug formulations without risk to humans. Scientists at California’s Stanford University, for instance, are taking part in the Living Heart Project, which uses a scientifically accurate digital 3D heart model to simulate how drugs affect the entire organ. The model also can predict the drugs’ risk of side effects such as lethal arrhythmias, the leading reason for the US Food & Drug Administration (FDA) to deny approval to a new drug.

“Modeling and simulation plays a critical role in organizing diverse data sets and exploring alternate study designs,” FDA Commissioner Scott Gottlieb said in July 2017, when outlining the regulatory body’s plan to help consumers capitalize on advances in science. “This enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trials.”

In April 2019, for example, global biopharmaceutical firm AstraZeneca confirmed that it will be using artificial intelligence and machine learning for the discovery and development of new treatments for complex diseases that include chronic kidney disease. AstraZeneca said it plans to use the technology to better understand the underlying mechanisms of complex diseases and more quickly identify new potential drug targets.

“The vast amount of data available to research scientists is growing exponentially each year,” Mene Pangalos, executive vice president and president of BioPharmaceuticals R&D at the company, said in a press release. “We can unlock the potential of this wealth of data to improve our understanding of complex disease biology and identify new targets that could treat debilitating diseases.”

Simulation also can help life science companies optimize their processes for drug manufacturing development.

“Scale-up in biopharma manufacturing is not a linear process,“ Matlis said. “While you may have mastered how to make a product in a 15-liter [approximately 4 gallon] vessel, when you scale up to 1,500 liters [approximately 400 gallons], you don’t just multiply everything by 1,000. You have to take into account a multitude of process variables to ensure product quality and yield.

“Traditionally, companies executed physical scale-up trials to hone the process variables and manufacturing equipment in order to be able to achieve sustainable, steady-state manufacturing,” he said. “Today we’re seeing innovative companies modeling and simulating these processes using digital twins of product, process and equipment, in order to scale up and achieve sustainable manufacturing levels – high quality, high effectiveness, high efficiency – while minimizing the number of actual test and validation runs that need to be done.”

DRIVING POSITIVE CHANGE

Regulatory bodies like the FDA play a key role in encouraging or discouraging the industry's use of technology innovation.

“Today, realistically, computer modeling and simulation does not play a driving role in regulatory decision making, but we want it to,” Tina Morrison, deputy director, Division of Applied Mechanics at the FDA, said at a 2018 conference. “We want to lessen the burden of evidence in clinical trials and animal studies. We want to do the work that’s necessary, not the work that we think is needed just because that’s what we’ve done for 20 years.”

Ultimately, Matlis said, pharmaceutical businesses must look at sustainability in drug discovery and manufacturing in a holistic way, across their entire
product lifecycle. “This is not just about reducing waste and packaging,” he said. “It’s about engraining innovation and sustainability concepts into the organizational culture and implementing the technology to achieve these goals.”

One major challenge, he said, is convincing pharmaceutical executives that the benefits of modeling and simulation in drug discovery, development and manufacturing are powerful – and real.

“When I talk to executives and we discuss modeling and simulation, using the example of the Living Heart Project, the reaction that I get most often is, ‘This cannot be real. This cannot be happening today,’” Matlis said. “They need to recognize that these technologies are not simply buzzwords. We need to shift from the paradigm that all these technologies are science fiction and realize that they’re science fact.” ◆

by Rebecca Lambert Back to top
by Rebecca Lambert

For more information on applying simulation to life sciences, please visit: https://go.3ds.com/fL9