From Confidence to Concern: The Shift in Spray Drying Sentiment

By: Dave Miller, CSO, AustinPx

I spent April on the move, coast to coast, conference to conference, hearing more than what was on the agenda. 

I began the month on the East Coast at Interphex in New York City (where I had the privilege of moderating a session on Amorphous Manufacturing Technologies (session details here). From there, I continued on to the Peck Symposium at Purdue University, where, among many excellent presentations on bioavailability-enhancing formulation technologies, Lindsay Wegiel of Eli Lilly and Co. presented on KinetiSol Technology. My trip across the country then concluded at the Drug Discovery Chemistry Conference in San Diego, where I had the opportunity to present on Formulation Strategies for Enabling Undevelopable Compounds. 

Across conferences and conversations, I engaged with some of the brightest minds in bioavailability and amorphous solid dispersions (ASDs). What stood out wasn’t just the science, it was the unspoken tension beneath it. Few addressed it directly, but the concern was clear: many companies are quietly anxious about how deeply they’ve come to rely on spray drying. Why the worry? There are several forces colliding that help explain the shift: 

• Rising commercial manufacturing demand, particularly with the explosion of high volume GLP-1 drugs that require spray drying 

• Growing regulatory signals, like the EPA’s recent indications of potential restrictions on organic solvents—especially chlorinated ones, used in spray drying (for example, see the EPA’s risk management actions on methylene chloride: EPA website) 

• The momentum of the green chemistry movement, as companies increasingly prioritize sustainable practices and seek to reduce the use of hazardous solvents and materials.  

• And perhaps most pressing, the hard economic and logistical realities: commercial spray-drying capacity is increasingly scarce, and building new capacity isn’t viable as installations often run into the tens of millions of dollars and can take up to four years to complete. 

In light of these trends, it’s hard not to ask: Why aren’t more companies aggressively exploring non-solvent-based technologies to de-risk their manufacturing strategies? 

In particular, KinetiSol stands out as a powerful alternative. This technology can deliver all the formulations that spray drying can, and then some. It offers a much wider formulation design space, produces particles with superior bioavailability, improves downstream processing, and enables better final dosage form design. 

What’s more, KinetiSol offers inherent cost and operational advantages that make it especially attractive at commercial scale. Because KinetiSol operates entirely without solvents, it eliminates the need for: 

• Purified nitrogen for processing 

• Energy to heat incoming process gas streams to evaporate organic solvents 

• Energy to re-condense organic vapors from nitrogen exhaust streams 

• Energy to purify and recycle reclaimed solvent 

• Secondary drying steps to remove residual solvent from spray-dried powders 

Additionally, spray drying at commercial scale is typically conducted in a stand-alone facility designed solely for that purpose, requiring substantial utilities and a large operational footprint. In sharp contrast, KinetiSol equipment has a compact footprint, about the size of a typical conference room table, requires only electricity and chilled water, and can be easily incorporated into existing GMP manufacturing suites without the need to build dedicated facilities. This simplicity, flexibility, and scalability make KinetiSol uniquely well-positioned to address the looming capacity and sustainability challenges facing the industry. 

Importantly, even if companies are not prepared to make a wholesale transition from spray drying to KinetiSol, they should be actively engaged in establishing KinetiSol capabilities as at least a contingency. With the rising pressures on spray drying, it is critical that companies have non-solvent alternatives ready and validated in their manufacturing toolkits so they are not caught flat-footed if the availability or acceptability of spray drying is suddenly impacted. 

As the pharmaceutical world confronts the new realities of commercial manufacturing, I believe the industry should be taking a much closer look at KinetiSol, not only as a superior technology for certain applications, but as a smart and proactive hedge against the risks of overreliance on spray drying. 

My trip across the U.S. wasn’t just about conferences and technical presentations. It was about listening, sensing the mood of the industry, and realizing that behind the guarded conversations, there’s a growing need for alternatives. KinetiSol is positioned to be part of that answer, and I’m convinced the time for the industry to take a serious look is now.