Particle engineering enhances drug solubility, bioavailability, and manufacturability. CDMOs like Evonik offer integrated expertise in crystallization, solid-state analysis, and process optimization, making them vital partners in pharmaceutical API development.
Particle Engineering: A Critical Enabler in Drug Substance Manufacturing
In pharmaceutical development, particle engineering plays a pivotal role in transforming promising molecules into manufacturable and effective drug substances. Most small molecule APIs are crystalline solids with limited solubility in physiological media, which directly impacts their bioavailability and therapeutic efficacy.
Particle engineering addresses these challenges by tailoring the physical properties of drug substances—such as solubility, dissolution rate, and particle size—to optimize performance and manufacturability. Crystallization, solid/liquid separation, drying, and milling are the unit operations that are optimized together to ensure the targeted crystal form is produced featuring the right particle size, shape. Also, these unit operations help control impurity rejection, filtration efficiency, and drying behavior, all of which are critical for robust and scalable manufacturing.
Drug developers often turn to Contract Development and Manufacturing Organizations (CDMOs) for particle engineering expertise. CDMOs provide the infrastructure, interdisciplinary teams, and analytical capabilities required to develop phase-appropriate processes. From early-stage solid form screening to late-stage process optimization, CDMOs help ensure that APIs meet regulatory, performance, and production requirements. Evonik stands out as an experienced CDMO partner in particle engineering. With deep expertise in crystallization science, solid-state characterization, and process development, Evonik integrates particle engineering seamlessly into drug substance manufacturing. Their teams collaborate across disciplines—from chemical synthesis to purification and formulation—ensuring a holistic approach to process design.
Evonik’s particle engineering labs are equipped with advanced analytical tools such as PXRD, DSC, and hot-stage microscopy, but also PAT tools, such as Raman and IR spectroscopy, in-situ microscope probes, and FBRM, enabling precise control and understanding over crystal forms, phase transitions, nucleation, growth, and particle size distribution changes. Their structured development workflows and scale-up capabilities ensure that lab-scale processes translate effectively to commercial production.
Real-world case studies from Evonik demonstrate their ability to solve complex challenges, such as poor filtration due to crystal morphology, solvent inclusions, and polymorphic transformations. These examples highlight the importance of understanding crystallization dynamics and impurity behavior to achieve robust, scalable solutions.
Particle engineering is not just a technical necessity—it is a strategic enabler of successful drug development. With Evonik’s integrated capabilities and proven track record, drug developers gain a trusted partner to navigate the complexities of API manufacturing and deliver high-quality therapies to market.
