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Master Spray Dried Dispersion Manufacturing Through Process Design and PPQ
Transform Spray Dried Dispersion Manufacturing — From Risk to Proven Process
Download the exclusive article from Serán and learn how Serán Bioscience’s differentiated process design and PPQ philosophy resolves scale-up uncertainty and sets complex molecules up for commercial success.
Pharmaceutical developers face intense pressure to accelerate from early formulation to commercial supply — often with limited process knowledge, high material costs, and regulatory uncertainty. Traditional trial-and-error approaches lead to delays, variability, and costly troubleshooting.
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Drug developers are caught between competing pressures:
• Speed to clinic vs. long-term manufacturability
• Early flexibility vs. commercial control
• Formulation success vs. process robustness
Traditional CDMO models often reinforce this conflict — focusing on producing material today, rather than ensuring the molecule can succeed tomorrow.
Serán approaches spray dried dispersion development differently.
Rather than asking “Can we make it?”, Serán asks:
“Can this molecule succeed — consistently, at scale, and under regulatory scrutiny?”
This article outlines how Serán:
• Integrates process design thinking from the earliest development stages
• Uses risk-based frameworks to guide decisions, not react to failures
• Treats PPQ as the outcome of deep understanding, not a checkbox
• Aligns formulation, equipment, and control strategy into a single, scalable vision
The result is not just material — but manufacturing confidence.
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Serán helps clients:
• Reduce scale-up and validation risk
• Preserve molecule optionality without sacrificing control
• Transition smoothly from development to commercial manufacturing
• Build regulatory-ready processes that perform as expected
Authored by
Tony Vickery
Principal Engineer
Process & Product Development
You can watch the webinar for more in-depth content here.
About Serán
Serán BioScience, LLC, is a science-driven Drug Development Partner, recognized as a world leader in drug development. Utilizing a foundation of physical and chemical science, Serán designs robust formulations and engineered solutions to some of the industry's toughest drug product problems. Our experience and background cover a wide range of pharmaceutical manufacturing concepts bringing our world-class expertise to you and your drug product. Serán’s team has decades of experience developing complex drug molecules into enabling medicines. With every addition to our team, we further our commitment to our clients’ success. From preclinical to GMP and beyond, Serán is here to support you and your drug product every step of the way.
For more information, visit www.Seranbio.com or email us at hello@seranbio.com.
Contact
Serán BioScience, LLC
63047 Layton Ave, Bend, OR 97701 USA
www.seranbio.com
