Facilities

Our 54-acre campus is ready to support small and large innovators with end-to-end capabilities including process development, analytical services, and cGMP API manufacturing. Recent capital investment enables operational expansion and further solidifies our decades of proven, highly adaptable approach enabling clients from clinic to commercial. We have 3 dedicated high potent suites to handle cytotoxic and other HPAPI needs through commercial scale. We also have a separate dedicated kilo-scale site for early clinical GMP supply needs. Our expertise in complex chemistry, our proven IND/NDA track record, and our flexible partnership model make Wilmington PharmaTech a comprehensive choice for programs that cannot afford delays. 

US Facilities Engineered for API, HPAPI, and Scale-Up Excellence

From our origins as a solid-state chemistry lab to our current 54-acre FDA-inspected campus, Wilmington PharmaTech has built a scalable, US-based infrastructure optimized for small-molecule API, HPAPI, and commercial manufacturing. Our sites combine the reliability of on-shore production with the flexibility needed for early-stage and fast-moving programs.

Hear our Managing Director lay out our manufacturing expansion plans in a CPHI interview

Integrated Development, Analytical, and Manufacturing Capabilities

  • Development Labs

    Four GMP suites with reactors up to 300 L

  • Commercial Facility

    100–750-gallon reactor bays for IND-enabling through small-scale commercial API

  • HPAPI-Ready Suites

    Purpose-built for OEB 5 containment; trained staff and full infrastructure in place for HPAPI runs

  • Comprehensive Analytics

    Method development, validation, release testing, ICH stability, impurity identification, and reference standards support

  • Extensive Storage

    18 refrigerators/freezers and over 5,000 cubic feet of ICH/photo-stability chambers for GMP materials and studies

Proven Regulatory Success and Technical Excellence

Wilmington PharmaTech has supported >200 IND submissions and multiple NDA filings, reflecting our ability to deliver well-designed processes, high-quality analytical data, and reliable cGMP manufacturing outcomes. Our team of experts collaborates closely with clients to anticipate regulatory needs, establish sound control strategies, and ensure each batch is supported by complete and compliant documentation, building confidence in every milestone.

  • Expertise in Complex Chemistry and Problem Solving

  • Integrated Teams for Seamless Scale-Up and Manufacturing

  • Comprehensive Delivery and Long-Term Client Partnerships

Wilmington PharmaTech is widely recognized for solving difficult synthetic and solid-state challenges, often rescuing projects that have stalled elsewhere. Our scientists routinely refine multistep routes, develop stable and scalable crystal forms, and address solubility or polymorph issues that can stall programs. We bring deep experience in asymmetric synthesis, chiral resolution, impurity control, and continuous-flow solutions for hazardous or sensitive chemistry. This problem-solving approach has enabled clients to overcome development roadblocks and advance programs that previously struggled at other CDMOs.

Our integrated model connects chemists, engineers, analytical scientists, and production teams from the outset to ensure smooth scale-up and predictable GMP execution. Cross-functional collaboration and daily alignment reduce tech-transfer risk, strengthen process understanding, and allow issues to be addressed quickly. This seamless handoff from lab to plant is a defining advantage for programs on tight timelines. We also offer stand alone analytical services to our clients who can benefit from our in house expertise.

Wilmington PharmaTech is known for on-time delivery and transparent communication, two qualities that underpin our long-standing relationships with both large pharma and emerging biotech companies. Clients rely on us to meet critical IND, clinical, and manufacturing deadlines, and we take that responsibility seriously. Our consistent performance over two decades has earned Wilmington PharmaTech a reputation as a dependable, flexible CDMO partner capable of supporting complex and time-sensitive programs.

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