New Suzhou facility complements existing U.S. infrastructure, delivering dual-continent containment capabilities for high-potency API programs
Suzhou, China — March 31, 2026 — Crystal Pharmatech, a global leader in solid-state and formulation science, today announced the official launch of its new OEB4/OEB5 high-potency laboratory at its global headquarters in Suzhou, China. The facility has passed rigorous independent third-party exposure control testing and is now fully operational — marking a significant milestone in the company's commitment to advancing complex pharmaceutical development.
This milestone meaningfully expands Crystal Pharmatech's infrastructure for highly potent compound development, further strengthening the company's integrated biotech CDMO services across solid-state research, preformulation, and crystallization process development. The new facility enables safer, more efficient, and highly specialized support for partners worldwide.
The Suzhou facility works in close coordination with Crystal Pharmatech's U.S. site in Cranbury, New Jersey, which is also fully equipped to handle OEB4/OEB5 compounds and controlled substances. This dual-continent capability ensures that global drug development programs benefit from seamless execution, regulatory compliance, and localized expertise across both major markets.
The new laboratory is purpose-built as a fully independent negative-pressure facility, designed to meet the stringent operational and containment requirements of high-potency drug development.
Key features include:
Full-room negative pressure containment to prevent the escape of highly potent compounds and protect both personnel and the surrounding environment
Dedicated gowning areas and controlled zoning for graded personnel protection and cleanroom management
Independent exhaust system designed for safe handling of high-potency operations
Multi-unit isolation system equipped with five high-performance isolators compliant with ISPE standards and JG/T385:2012, ensuring all open handling of potent compounds is conducted in a contained environment with fully closed material transfer
Together, these systems establish a robust safety framework for conducting complex studies involving highly potent APIs (HPAPIs).
To support the full lifecycle of solid-state research under containment, the laboratory integrates a robust suite of high-precision instrumentation, including:
Structural & Thermal Analysis: Powder X-ray Diffractometer (XRPD), Thermogravimetric Analyzer (TGA), and Differential Scanning Calorimeter (DSC).
Specialized Environmentals: Biochemical incubators, vacuum ovens, and explosion-proof refrigeration.
Precision Measurement: High-sensitivity analytical balances with 0.01 mg readability.
This integrated platform supports the full workflow from API solid-state characterization to early-stage crystallization process development under safe and contained laboratory conditions.
Highly potent drugs—including oncology therapies and targeted small-molecule drugs—are becoming increasingly important in modern pharmaceutical pipelines. These programs require advanced containment systems, specialized expertise, and high-precision experimental capabilities.
With the new high-potency laboratory, Crystal Pharmatech now offers integrated development support covering the critical early stages of potent compound development.
Current services available include:
Using minimal API material, this platform rapidly evaluates the biopharmaceutical classification of drug candidates and generates development guidance maps, formulation decision trees, and predicted preclinical dose information to support solid-form selection and formulation strategy.
Comprehensive studies including polymorph identification, thermal analysis, hygroscopicity evaluation, and stability studies to establish a complete understanding of API solid-state properties.
Multi-condition polymorph screening conducted within a high-potency isolation environment, improving safety while maintaining high discovery efficiency and data reliability.
Single crystal growth experiments combined with high-resolution diffraction analysis allow precise determination of the three-dimensional structure of highly potent compounds, providing gold-standard evidence for polymorph confirmation.
Preformulation studies such as solubility testing and preliminary formulation screening based on comprehensive solid-state data to support stable and robust drug product development.
Small-scale crystallization process development including solvent screening, crystallization pathway design, and process parameter optimization to support future scale-up and manufacturing.
With advanced containment systems, modern analytical instrumentation, and coordinated laboratory capabilities spanning China and the United States, Crystal Pharmatech continues to raise the bar for high-potency drug development and complex pharmaceutical programs.
The new facility will help partners:
Reduce development risks
Accelerate project timelines
Ensure operator safety and data reliability
Advance innovative therapies with confidence
By integrating this new Suzhou OEB4/OEB5 laboratory with our existing New Jersey infrastructure, we have strengthened our ability to serve as a leading global partner for complex drug development. Our mission is to empower our partners by minimizing risk and ensuring researcher safety, all while accelerating the journey of life-changing therapies to patients.
Crystal Pharmatech is a global leader in solid-state and formulation science, offering end-to-end drug development solutions from preclinical candidate selection through clinical supply. With operations in the United States, Canada, and China, the company supports pharmaceutical and biotech partners worldwide through deep technical expertise and flexible service models.
Renowned for its excellence in crystal form screening and selection, preformulation, and formulation development, Crystal Pharmatech helps optimize developability and bioavailability across diverse drug modalities. Its integrated services span Mol2Med™ developability assessment, solid-form screening, crystallization process development, formulation development, and GMP manufacturing for Phase I–III clinical trials and commercialization.
Whether advancing a preclinical candidate to first-in-human studies or resolving formulation challenges in a clinical-stage program, Crystal Pharmatech is a trusted partner for solving complex crystal form and formulation problems with speed and precision.
With a scientific team averaging 20 years of experience, the company has supported over 2,000 clients, enabling development of more than 4,000 preclinical compounds. Its multi-site presence across North America and Asia gives clients strategic flexibility and consistently high-quality service across regions.
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