The top 3 challenges to next-gen processing and how the industry is racing forward
MilliporeSigma introduced its new BioContinuum Platform at the 2018 AAPS PharmSci 360 Annual Meeting in Washington, DC. New to the BioContinuum portfolio is the Pellicon Single-Pass Tangential Flow Filtration.
“Our BioContinuum Platform features next-generation technologies to obtain incremental process benefits now, with a mind to the continuous process of the future,” said Andrew Bulpin, head of Process Solutions at MilliporeSigma.
Bulpin told us the company’s holistic approach to process intensification allows it to realize the benefits of process intensification over the entire process, benefits not gained by focusing on one area at a time.
The benefits of process intensification – which shrinks manufacturing equipment size to produce drugs in smaller batches – include reduced manufacturing plant footprints and costs. “This is significant when thinking about providing greater accessibility of drugs in emerging countries or helping support small- and mid-size biotechs get their drugs to market,” Bulpin explained.
“We are living in a fast-paced, evolving life science environment in which more chronic diseases are prevalent, racing against time to find medical solutions to treat patients faster and more effectively.”
Uncertainty, new product classes, and cost pressures are driving a paradigm shift and the need for innovation in what has historically been a conservative industry. Additionally, developments in emerging countries are creating the need for modular, “quick scale-up” facilities over the next five to 10 years.
Bulpin explained, “While in its infancy, next-generation processing is predicted to have a significant impact on how our customers bring therapies to market, delivering them to patients faster and more cost-effectively than ever before.”
Requirements, resistance, and regulations
When asked what the top three industry goals are as it pertains to next-generation processing technologies, Bulpin listed higher productivity and speed, increased manufacturing flexibility, and reduced cost of goods.
All of these address current customer challenges – and while Bulpin said continuous processing is the future of drug manufacturing, a fully continuous process is not necessary for customers to see benefits.
“We see a large amount of innovation happening around the analytics and sensing technologies in particular at this point in time,” he added, noting that advancements in these areas will be required to achieve a fully continuous process in the future.
Also key to this future is overcoming the fear of and resistance to change, which Bulpin described as some of the biggest hurdles to the transition to fully continuous manufacturing. “Biologics have been made essentially the same way for more than 30 years,” he added.
Clearing regulatory hurdles is the key business risk to fully continuous manufacturing, he explained, “As processes look less like a series of sequential operations and more like an automated assembly line.” This subsequently poses the question: “How do you define a batch?”
Delays in product approvals also have a major effect on revenue and market position, which drives a risk-average culture, and in the near term, Bulpin said regulatory approval is expected to take longer for continuous processes.
“Until the approval of several molecules produced in a continuous manner, the regulatory bodies will place increased scrutiny on these processes,” he explained, adding that discussions with the FDA have shown a support of continuous processing.
MilliporeSigma will focus on regulatory guidance within its BioContinuum Platform in 2019, Bulpin said.
The company also will continue to collaborate with its customers as it looks to develop the processes of the future, he explained.
“This manufacturing evolution requires a strong collaboration between suppliers, biomanufacturers and regulators – and sometimes even beyond by including academia, industry associations,” Bulpin added. “For decades, MilliporeSigma has collaborated with its customers to shape how drug production is done today, and will continue that to shape the possibilities of tomorrow."
