U.K. starts building a 'factory of the future' to overhaul small-molecule drug production

The Medicines Manufacturing Innovation Centre already has two technology challenges underway to overhaul the tablet manufacturing process and work toward just-in-time production of drugs. (CPI, Medicines Manufacturing Innovation Centre)

The U.K. is already working to overhaul production methods for biologic drugs, cell and gene therapies and vaccines, and, now, it's started construction on a new innovation center that'll focus on small-molecule meds.

Set to come online in early 2022, the Medicines Manufacturing Innovation Centre will explore next-generation technologies to overhaul drug manufacturing, aiming to reduce waste, cut clinical and commercial production costs and, ultimately, leverage new methods to quickly deliver patient-friendly medicines. 

The goal is to position the center as a "factory of the future," Dave Tudor, managing director of the Medicines Manufacturing Innovation Centre's quality and biologics work, said in an interview.

To that end, the innovation center will adopt a paperless, digital model. It will also incorporate artificial intelligence along with virtual reality and augmented reality, which could be used to help train partners on new tech. 

Drugmakers, academic institutions, healthcare providers and regulators are expected to come together at the facility to test and improve new technologies, including continuous, digital and autonomous manufacturing. That work, in turn, could clear the way for their adoption in the industry, the center's umbrella organization, CPI, said in a release. 

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A collaborative effort between CPI, the University of Strathclyde, GlaxoSmithKline and AstraZeneca—with funding from Scottish Enterprise and UK Research and Innovation—the innovation center already has two technology challenges underway, two so-called "Grand Challenges," which it's been working on for about 18 months, Tudor said.

The first challenge aims to use continuous direct compression to change how drug tablets are made—a process that's remained static for about a century, Tudor said. 

"We still bash bits of metal together. That's the reality. But because we do that, we waste a lot of the expensive APIs."

By leveraging continuous manufacturing, the Medicines Manufacturing Innovation Centre hopes to reduce drug waste from typically 30% today to less than 5%, he said. 

Meanwhile, the center also hopes to use data twins—effectively digital replicas of the manufacturing process—to help drugmakers predict whether an active pharmaceutical ingredient could actually bind together using that continuous method. The resultant reduction in waste "could be a breakthrough" in terms of drug affordability, Tudor figures. 

The center's second Grand Challenge covers delivery of clinical supply to patients enrolled in trials. Drugmakers tend to over-manufacture for their clinical studies, Tudor said, and, in the event that a study gets canceled, companies are often left with huge stores of leftover product. 

"Typically, a drug company can be throwing away £30 million per year of drugs for clinical manufacture."

As for how that would work, the innovation center envisions taking an individual blister pack, putting a patient's name on it and then making it available right when patients need it. 

Just-in-time manufacturing could also help simplify medication regimens for older patients by combining multiple drugs into a single weekly—or even daily—blister pack, Tudor figures, and Grand Challenge 2 lays the foundation for this. 

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Dave Tudor said the Medicines Manufacturing Innovation Centre was equipped with just over £60 million (about $78 million) to build the center, fund its first two Grand Challenges and pay around 80 staffers to see it through the first phase of operations.

The center also plans to "imminently" announce two more Grand Challenges "in the order of an increment of about £20 million each," he added. If the center unveils two new technology challenges every 18 months as planned, Tudor expects its funding to grow to about £100 million (roughly $130 million) within the next two years. 

In the meantime, it has already racked up four partnerships, with two or three more in the late stages, Tudor said. 

CPI, which leads the partnerships at the center, signed on Siemens, Perceptive Engineering and Process Systems Enterprise (PSE) in August. Siemens is on deck to provide software and hardware to enhance control over the manufacturing process, while Perceptive Engineering will use its fully integrated software platform, PharmaMV, to assist with optimized continuous manufacturing. 

PSE, for its part, will use predictive process modeling to increase R&D efficiency, reduce tech transfer risk and develop more robust control strategies, CPI said in a release. 

In September, Applied Materials joined the effort, too, chipping in its SmartFactory Rx automation software to support the Medicine Manufacturing Innovation Centre's just-in-time manufacturing goals. 

Editor's note: This article was updated to reflect the naming conventions for the Medicines Manufacturing Innovation Centre and CPI and to clarify a quote and the timing of the center's ongoing Grand Challenges.