Overcoming Late-Stage Formulations & Manufacturing Challenges with KinetiSol Technology

Biotech, Drug Discovery & Development, Life Science, Pharma, Pharma Manufacturing & Supply Chain,
  • Thursday, November 06, 2025 | 1pm EST (10am PST)
  • 60 min

Many drug developers rely on spray-dried dispersions (SDDs) for early-phase development of poorly soluble compounds. While this approach offers speed and regulatory familiarity, it often leads to significant challenges later in the development process. Formulation limitations, high pill burden, inefficient solvent use and scale-up issues can make SDDs impractical for late-stage or commercial manufacturing. Join this webinar to explore how converting SDDs to KinetiSolâ„¢ dispersions (KSDs) offers a viable solution and how this strategy can enhance manufacturability, enabling the development of more robust drug products.

Spray drying is widely accepted for clinical entry but frequently falls short during scale-up. The limitations are well-known: poor solids loading, excessive solvent use and inefficient tablet manufacturing. These barriers often prevent programs from progressing beyond Phase II.

KinetiSol is a solvent-free, high-energy fusion process that avoids these scale-up bottlenecks. It expands the formulation design space, enabling the development of higher-performing drug products. In this session, a real-world case study will demonstrate how a low-loading SDD was reformulated into a KSD with six times higher bioavailability and improved tablet properties. Key improvements included the elimination of solvents, simplification of the tablet composition and a significant reduction in pill burden.

Attendees will learn how converting to KinetiSol can boost bioavailability, streamline manufacturing and improve scalability for late-stage drug development.

Register for this webinar to learn how KinetiSol solves formulation and manufacturing challenges for late-stage development.

Speaker

Dave Miller, AustinPx

Dave Miller, PhD, Chief Scientific Officer, AustinPx

Dr. Dave Miller currently serves as the Chief Scientific Officer at AustinPx, where he leads the pharmaceutics and analytical development teams and oversees the application of the KinetiSol™ Technology. He specializes in formulation and processing technologies for improving the oral bioavailability of insoluble small molecules. He has applied his expertise toward advancing numerous drug candidates through all stages of development, from early discovery to line extensions.

Dr. Miller is the co-inventor of the pharmaceutical applications of KinetiSol Technology and continues to be a key driver of innovation for the application and expansion of the platform. Dr. Miller earned his PhD in Pharmaceutics from the University of Texas at Austin.

Message Presenter

Who Should Attend?

This webinar will appeal to Director/Senior Director/Vice President working in pharmaceutical or biotech manufacturing or related job titles:

  • Research
  • CMC Management
  • Product Development or Drug Product Development
  • Pharmaceutical Operations
  • Pharmaceutical Technology
  • Process Chemistry
  • Formulation Development
  • Technical Operations
  • Technical Development
  • Scientist/Senior Scientists, Early-Phase Development
  • Process Development Scientists
  • Consultants

What You Will Learn

Attendees will learn:

  • Why spray drying is often chosen for early clinical development despite late-stage limitations
  • Converting SDDs to KSDs improves bioavailability, pill burden and manufacturability
  • The role of solvent-free processing in overcoming scale-up bottlenecks and inefficiencies
  • About case study results that demonstrated a six-fold increase in bioavailability with KinetiSol

Xtalks Partner

AustinPx

AustinPx, Pharmaceutics and Manufacturing, is a contract development and manufacturing organization (CDMO) providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. AustinPx specializes in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules- including our next generation amorphous dispersion platform, KinetiSolâ„¢ Technology.

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