As innovative therapies continue to expand what’s possible in medicine, how companies design and execute development and manufacturing is becoming just as decisive as the science itself.
Process intensification, or taking steps to increase throughput or manufacturing efficiency, plays a critical role on this front. Successful intensification initiatives don’t just help biopharma developers gain a competitive edge, but they also help avoid manufacturing disruptions that can interrupt patient access or increase therapeutic costs.
However, process intensification only delivers when developers can make confident, informed choices about how to optimize their processes. That starts with a clear understanding of what intensification looks like in practice—and the concrete steps other teams have taken to translate it into meaningful, measurable gains.
Here, we’ll share the truth behind four persistent misconceptions around process intensification, gleaned from a survey of more than 150 life science veterans — most of whom have been working in the industry for 10+ years — conducted in partnership with Thermo Fisher Scientific and BioPharma Dive. You’ll learn which myths may be holding your intensification efforts back, and the steps you can take to lay the foundation for success.
Misconception: Process intensification will invite regulatory scrutiny
Fact: The FDA has acknowledged that advanced manufacturing techniques play an important role in drug development
Any change in process, platform or technology can raise concerns around regulatory approvals. And four out of five leaders whose organizations had not deployed process intensification strategies cited regulatory concerns as their top reason why.
But FDA leadership has acknowledged its role in supporting manufacturing innovation for helping patients access the life-saving therapies they need. The FDA is now providing guidance on activities associated with intensification, including real-time release. And the key to success is engaging regulatory experts early to anticipate and mitigate potential risks.
“I think earlier regulatory and quality guidance would give teams more confidence to move forward with improvement instead of automatically sticking with the current process just because it feels safer,” one respondent shared.
Misconception: We need widespread or integrated intensification initiatives to realize significant results
Fact: Most biopharma developers are taking a modular approach to intensification, and they’re seeing significant results
Developers can employ intensification strategies at any stage during therapeutic development, from discovery to commercial manufacturing. But that doesn’t mean companies need to invest in integrated, end-to-end solutions immediately.
In fact, just 4% of biopharma executives said their organization had a fully integrated intensification strategy. The vast majority — 88% — stopped short of full integration and said their companies are selectively or broadly employing intensification practices across one or more programs (the remaining 8% said their companies are at the early stages of intensification).
But these stepwise efforts have been enough to yield significant results. More than half of respondents (52%) said they were seeing fewer material bottlenecks and less supply interruption, and 42% said intensification has helped speed time to market.
Misconception: Our first intensification initiative failed. It's just not for us
Fact: Failure is part of the process — and it doesn’t mean you won’t realize positive results over time
While biopharma executives say they’re seeing a number of positive outcomes from process intensification, the path to success isn’t always linear
The truth is that most biopharma developers will need to iterate to realize results. And nearly three-quarters of respondents (73%) admit that some initiatives or investments in process intensification failed to yield significant outcomes or yielded negative outcomes.
However, companies can take steps to maximize their chances of success. Standardizing processes early is critical — 59% of respondents cited challenges on this front as the top reason intensification efforts failed to yield positive results.
So is bringing together key stakeholders, such as compliance, IT, CMC, and executive leadership to align on objectives and approach, since lack of alignment contributed to intensification failures 55% of the time. As one respondent said, “Clear decision structures give leaders the confidence to act because they know when input is needed and when it is time to move forward.”
Misconception: Successful intensification is mostly about finding the right technology or provider
Fact: Developers should pair investments in technology with governance frameworks to succeed
Ultimately, the right technology plays a pivotal role in successful process intensification. But success also heavily relies on the processes that shape how you use the tech. Nearly three-quarters (73%) of respondents said their company facilitated intensification by creating standardized SOPs and documentation across programs, sites or modalities. And 64% strengthened internal quality control systems to support the higher throughput that intensification provides.
Governance frameworks are also key, respondents report. “A governance model should be there which clearly states the framework for vendors and CROs that will bring clarity to expectations and goals,” one respondent shared. “A well-maintained and managed framework would make sure that people work on what matters and make better decisions.”
Learn how top biopharma leaders are leveraging process intensification to avoid material bottlenecks, manage trial or development costs and enhance throughout in our latest research report. GET THE REPORT >
