Capabilities
GMP Manufacturing
GMP Manufacturing Where Chemistry Performs at Scale
Wilmington PharmaTech provides clinical and commercial GMP manufacturing for small molecules and HPAPIs within FDA-inspected US facilities up through peptides.
Our manufacturing capabilities include dedicated HPAPI suites, kilo-lab, pilot, and commercial-scale infrastructure, supported by strong quality systems and experienced production teams focused on reliable execution.
“Our foundation is best-in-class API development backed by a proven record of customer value creation.”
Hui-Yin Harry Li, Ph.D,
CEO & Founder of Wilmington PharmaTech
Clinical and Commercial API Production
Wilmington PharmaTech supports both clinical and commercial API manufacturing across a range of batch sizes and program stages. Our infrastructure enables efficient progression from kilo-scale production through pilot-scale and into commercial supply, without disruptive technology transfers.
Manufacturing activities are supported by experienced production chemists, engineers, and quality professionals who work closely with development teams to preserve process understanding and ensure reliable execution.
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Early-phase and late-phase clinical API production
Commercial scale manufacturing for small molecule APIs
Seamless transition from development into GMP production
Long-term supply support for approved products
This depth of understanding reduces uncertainty as programs progress and supports confident regulatory submissions.
Specialty Scaffolds, Late Stage Intermediates, and RSMs
At the request of many clients, Wilmington PharmaTech has created a unique catalogue of difficult-to-synthesize starting materials and analogues available at Kg scale to facilitate discovery and IND-enabling activities. A pdf list of these compounds is available upon request.
High-potency APIsDedicated HPAPI Manufacturing Capabilities
High-potency APIs require specialized infrastructure, containment, and expertise. Wilmington PharmaTech operates dedicated HPAPI manufacturing suites designed to safely handle complex and potent compounds while maintaining GMP compliance.
HPAPI manufacturing is supported by purpose-built containment systems, engineering controls, and operational practices that enable safe, repeatable production.
HPAPI capabilities include:
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Dedicated HPAPI kilo lab production suites
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Walk-in hoods and controlled containment environments
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Reactor capacities supporting development through commercial scale
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Integration with analytical and quality systems for full lifecycle support
These capabilities position Wilmington PharmaTech to support increasingly complex and high-potency programs as they advance toward commercialization.
FDA-inspected manufacturing facilitiesUS-Based, FDA-Inspected Manufacturing Facilities
Wilmington PharmaTech operates FDA-inspected manufacturing facilities in Delaware, located on a former DuPont/Merck site with a long history of chemical manufacturing excellence.
Our facilities support development, clinical, and commercial activities within a single US-based footprint, providing regulatory alignment, supply chain confidence, and direct access to scientific and operational teams.
Facility highlights include:
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Multiple GMP kilo lab production suites
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Commercial-scale manufacturing capabilities
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Reactor volumes ranging from laboratory scale to hundreds of liters
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Infrastructure designed to support expansion and long-term growth
Capacity Designed for Scale and Growth
Wilmington PharmaTech’s manufacturing infrastructure is intentionally designed to support scalability and future expansion.
Manufacturing Capacity OverviewCapability AreaCurrent CapacityGMP Kilo LabsMultiple dedicated GMP kilo lab suitesBatch Scale RangeFrom kilograms to tens of kilogramsLargest Single Batch Produced100 kgReactor VolumesLaboratory scale through several hundred litersCommercial-Scale ManufacturingCommercial plant supporting scale-up and pre-commercial productionHPAPI ManufacturingDedicated HPAPI suites with engineered containmentCommercial ManufacturingCapable of supplying commercial-scale API productionExpansion PotentialSignificant permitted space for future capacity growthQuality Systems and Regulatory Compliance
Quality is embedded into every aspect of Wilmington PharmaTech’s manufacturing operations.
Our quality systems support GMP compliance across clinical and commercial production, with processes designed to ensure data integrity, traceability, and regulatory readiness. Manufacturing operations are supported by experienced quality and compliance teams who work closely with clients to meet regulatory expectations.
Quality and compliance focus areas include:-
Quality Management System (QMS)
Robust documentation, change control, deviation management, and CAPA
Facilities & Equipment
Qualified, maintained, and inspection-ready manufacturing infrastructure
Materials Management
Supplier qualification, material traceability, and controlled handling
Production Systems
Validated, controlled, and reproducible manufacturing processes
Laboratory Controls
Compliant analytical methods, data integrity, and investigation practicesThis depth of understanding reduces uncertainty as programs progress and supports confident regulatory submissions.
Additional
Capabilities
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