Capabilities
Solid State Chemistry
Solid-State Chemistry Solutions for Long-Term Success
Solid-state behavior is one of the most common sources of late-stage development delays and failures. Wilmington PharmaTech’s early intervention approach provides comprehensive solid-state chemistry expertise to identify optimal forms early to enable speed to the clinic and success in the market and avoid late-stage surprises.
Our scientists apply systematic salt selection, polymorph screening, and crystallization optimization to enhance stability, bioavailability, and manufacturability, often enabling molecules that had originally faced seemingly insurmountable physicochemical barriers to the clinic.
Salt Selection and Polymorph Screening
The choice of solid form has far-reaching implications across development, regulatory strategy, and commercial manufacturing. Wilmington PharmaTech applies a systematic, science-driven approach to salt selection and polymorph screening to identify forms that balance performance with long term reliability.
Our solid form evaluation considers:
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Chemical stability and hygroscopicity
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Solubility and bioavailability potential
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Crystallinity and solid-state transitions
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Intellectual property landscape
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Scalability and reproducibility
By evaluating these factors in parallel, Wilmington PharmaTech helps clients avoid selecting forms that perform well initially but create challenges later in development or manufacturing.
This work is informed by experience supporting hundreds of API candidates and advancing high-quality IND and NDA submissions.
Crystallization Optimization as a Development Tool
Crystallization is a powerful lever for controlling solid form, particle attributes, and process robustness.
Wilmington PharmaTech’s scientists design and optimize crystallization processes to support consistent solid form control while enabling scalable, reproducible manufacturing. Variables such as solvent systems, cooling profiles, seeding strategies, and impurity effects are evaluated systematically. By optimizing the crystallization of the compound, we can achieve more consistent polymorph control, improve yield and purity, better manage particle size and morphology, and create a robust, transferable process.
Our Founder, Hui-Yin Harry Li, Ph.D, describes how Wilmington PharmaTech can create new and improved crystal structures of their clients’ compounds to breathe new life into “dead” programs.
Physical Characterization and Solid State Understanding
Comprehensive physical characterization underpins all solid-state decisions at Wilmington PharmaTech.
Our teams apply a range of analytical techniques to build a detailed understanding of solid-form behavior, enabling data-driven decisions throughout development. Characterization is used not only to identify forms but also to understand how they respond to processing conditions, storage, and handling.
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Thermal analysis
Spectroscopic methods
Powder diffraction
Moisture sorption studies
Stability under stressed conditions
This depth of understanding reduces uncertainty as programs progress and supports confident regulatory submissions.
From Solid State Science to Manufacturability
Solid-state decisions are only valuable if they hold up in manufacturing.
Wilmington PharmaTech integrates solid-state chemistry with process development and manufacturing considerations from the outset. Our teams evaluate how selected forms behave during scale-up, isolation, drying, milling, and storage, identifying risks before they become production issues.
Manufacturability considerations include:-
Form stability during scale-up and isolation
Sensitivity to processing conditions
Batch-to-batch reproducibility
Handling, flow, and storage behavior
This depth of understanding reduces uncertainty as programs progress and supports confident regulatory submissions.
Additional
Capabilities
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