Capabilities
Development Services
Development Services Built for Translation
Wilmington PharmaTech’s development services bridge the gap between laboratory chemistry and commercial manufacturing. Our Process Development team has a demonstrated track record of providing solutions to some of the most challenging synthetic routes. Our teams bring decades of experience to design, optimize, and scale processes with a focus on robustness, safety, and regulatory readiness.
Your project will have the personal attention of senior staff in support of API and HPAPI development through integrated process development, analytical method development, and IND-enabling services to prepare programs for clinical and commercial success.
API and HPAPI Synthesis for Complex Programs
Wilmington PharmaTech brings extensive experience synthesizing both APIs and high-potency APIs, including molecules with challenging reaction profiles, tight impurity limits, and complex safety considerations.
Our development chemists work closely with engineering, analytical, and manufacturing teams to ensure synthetic routes are designed for containment, control, and repeatability from the outset.
Development synthesis capabilities include:
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Complex multi-step small molecule synthesis
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HPAPI route development within dedicated containment environments
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Evaluation of alternative synthetic strategies to improve robustness
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Impurity identification and control strategies
This integrated approach allows chemistry decisions to be informed by both safety and scalability requirements.
Our Founder, Hui-Yin Harry Li, Ph.D, describes how Wilmington PharmaTech employs advanced purification techniques early in development to improve the development process
Process Development and Optimization
Process development at Wilmington PharmaTech focuses on building understanding, not just achieving yield.
Our teams systematically evaluate reaction conditions, reagent selection, solvent systems, and workup strategies to develop processes that are reproducible, controllable, and aligned with manufacturing realities. Optimization efforts prioritize robustness and consistency alongside efficiency.
Rather than optimizing in isolation, Wilmington PharmaTech’s process development work is informed by solid-state behavior, impurity formation, and analytical feedback, ensuring processes are well characterized and defensible.
Designing for Scale Up and Commercial Readiness
Scale-up introduces challenges that are often invisible at laboratory scale. Wilmington PharmaTech addresses these challenges early through deliberate process design and close collaboration between development, manufacturing, and EHS teams.
Key considerations such as process safety, heat transfer, mixing, reaction kinetics, and isolation behavior are evaluated as processes move from laboratory to kilo lab and commercial scale.
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Evaluation of scale-dependent risks
Definition of critical process parameters
Development of scalable isolation and purification steps
Preparation for validation and long-term manufacturing
This depth of understanding reduces uncertainty as programs progress and supports confident regulatory submissions.
Analytical method development
Embedded Analytical Method Development
Analytical method development is embedded within Wilmington PharmaTech’s development services, not treated as a parallel or downstream activity.
Analytical scientists work alongside development chemists to design methods that support process understanding, impurity tracking, and regulatory requirements. This integration enables faster iteration, clearer data interpretation, and stronger alignment between chemistry and analytics.
Methods developed during this phase are designed to transition seamlessly into GMP environments, supporting both development and manufacturing needs.
Additional
Capabilities
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