ChemExpress provides an integrated CRO&CDMO platform covering drug discovery reagents, intermediates, APIs, biologics, and finished drug products. Built around an end-to-end development path from starting materials to finished dosage forms, we support key stages including preformulation research, formulation process development, clinical sample supply, process validation, and commercial supply. This integrated model helps customers reduce uncertainty caused by cross-vendor handoffs.
ChemExpress Formulation Development Capabilities
Formulation development is a critical step in turning an active ingredient into a usable drug product. It not only determines whether a stable dosage form can be developed, but also affects dissolution performance, bioavailability, process scale-up, quality control, stability studies, and regulatory submissions.
The ChemExpress Shanghai R&D center supports the development of oral solid dosage forms, including controlled-release formulations, oral solution formulations, topical ointments, and injectable formulations. Our formulation team has years of experience in both formulation development and production, with strong technical platforms in controlled-release formulations and solubility enhancement for poorly soluble drugs.
For innovative drug programs, formulation development is no longer just a laboratory screening activity. More than 70% of drug candidates in development face BCS Class II or Class IV solubility challenges. For these compounds, solid-form selection, particle engineering, dissolution enhancement strategy, excipient system design, and process route selection can directly affect downstream drug product manufacturing and regulatory comparability.
ChemExpress GMP Drug Product Manufacturing Capabilities
Formulation development capability is only the first step. For clinical sample supply, registration batch manufacturing, process validation, and commercial supply, customers also need a CDMO with real, executable, and auditable GMP drug product manufacturing capabilities.
The ChemExpress Qidong GMP drug product manufacturing site in Jiangsu covers approximately 14,000 square meters and includes 8 independent Class D cleanroom workshops. The site includes 4 oral solid dosage workshops with annual capacity of approximately 1 billion units, 3 semi-solid topical dosage workshops with annual capacity of approximately 50 million tubes, 1 solid dispersion production line, and a dedicated targeted drug product line with OEB3/4 containment protection.
The site supports tablets, granules, hard capsules, powders, ointments, creams, and gels. Batch sizes range from approximately 3,000 units for R&D batches to approximately 3 million units for commercial-scale batches, supporting different project stages from early development to commercial supply.
The solid dispersion production line supports products that require amorphous solid dispersion, or ASD, formulation strategies. As poorly soluble compounds continue to represent a large share of development pipelines, technical platforms such as hot melt extrusion and spray drying are becoming important capabilities for drug product development and manufacturing platforms.
Advantages of Having Both Formulation Development and Manufacturing Services
ChemExpress provides both formulation development and GMP drug product manufacturing capabilities, helping projects maintain stronger continuity from formulation design to production scale-up. Process understanding, analytical methods, and quality control strategies developed during formulation work can move more smoothly into later GMP manufacturing.
For customers, this integrated model brings three direct benefits. First, manufacturability can be considered earlier during development, reducing the risk of late-stage process adjustment. Second, the path from R&D batches to clinical batches, registration batches, and commercial batches becomes clearer. Third, analytical, quality, and regulatory CMC documentation can follow a more consistent technical logic.
Through an integrated CDMO platform covering starting materials, intermediates, APIs, and drug products, ChemExpress connects development, analytics, GMP manufacturing, and regulatory support more closely. This helps customers reduce cross-vendor transfer risks and accelerate the transition from formulation development to drug product manufacturing.
Technology Transfer and Custom Manufacturing Experience
In addition to formulation development and drug product manufacturing services, ChemExpress also supports technology transfer and custom manufacturing. Since 2003, we have successfully completed process transfer and scale-up for more than 80 projects, with selected projects reaching hundreds of tons in scale.
This experience reflects our long-term capabilities in process understanding, scale-up validation, manufacturing transition, and project management. For customers moving from early development to larger-scale production, mature technology transfer experience can help projects move more smoothly across development, validation, and commercialization stages.
Project Experience Demonstrating Integrated Delivery
To date, ChemExpress has supported 9 MAH drugs successfully reaching the market. This reflects our ability to support projects from R&D through post-approval commercial supply.
From 2020 to 2025, ChemExpress completed pharmaceutical research and IND submissions for approximately 140 innovative drug programs covering APIs and drug products. Among them, 100 involved China-U.S. dual filing projects. For customers targeting multiple regulatory markets, this experience helps projects build a more consistent technical logic across formulation, process, analytics, stability, and CMC documentation.
Integrated delivery takeaway: A formulation partner with both development and GMP manufacturing capabilities can help reduce transfer friction, improve technical continuity, and support smoother progression from early formulation studies to clinical, registration, and commercial supply.