Pfizer’s ‘long and complex’ journey to continuous manufacturing
Alastair Coupe, the senior director of Drug Product Design and Pharmaceutical Sciences at Pfizer, described the company’s journey on continuous drug processing, during a panel discussion at the Pharma Integrates conference that took place last week in London.
According to the executive, Pfizer’s interest in continuous processes started in the ‘90s, however, the company developed a stronger appetite for investments in the early ‘00s, with the first white papers for related equipment and training published 12 years ago, in 2007.
“We have worked pretty constantly on such technologies since then, and established several collaborations as well, without which we wouldn’t be where we are today,” Coupe noted.
Collaborations are important on such matters due to the need for heterogeneity, diversity, and unity across multidisciplinary teams, in order for the technology to evolve, the executive noted.
Since the initiation of ‘experimental’ work in 2007, Pfizer continued with the building of the equipment and saw the first product processed under continuous manufacturing approved by the Food and Drug Administration (FDA) in 2017.
“The journey of educating the regulators was significant as well, since this technology was brand new to them,” Coupe noted. Adding that, although engineers and formulation scientists of the company had already been working for years on the technology, regulators were not familiar with the process.
“We had to bring them on the journey with us,” he said, and added that representatives of the FDA were ‘very supportive and receptive.’
Coupe stated that the company has another product scheduled to be filed for approval in the upcoming year, as well as another one for the year after that.
Moreover, the executive suggested that Pfizer’s strategy on continuous manufacturing differs from that of other companies since “it’s not continuous at the back of the batch, but it is continuous because we do everything mechanistically: from modeling to the end with very little scale-up and technology transfer.”
According to Coupe, the ‘call’ of today’s market is “to get products to patients as quickly as possible: accelerate, accelerate, accelerate,” and that is what the company aims to achieve through integrating continuous processes, since “it is the quickest and the most efficient way to get products to market.”
The executive suggested that Pfizer recognizes the benefits of continuous manufacturing and that the company has been on a “long and complex journey” regarding the use of such processes, citing how much the technology has evolved during even recent years.
“Those learnings will now be available to others outside of big pharma, so that they can learn, adapt and adopt quicker,” he stated, continuing that “if we have capacity issues, we just have to turn the machine faster.”
“It would be nice to have options to outsource in that area, but at the moment that side of the world is a little bit behind us,” he concluded.