Our Services
Dow Development Labs, LLC (DDL), a specialty contract development and manufacturing organization, provides drug product design and development services for pharmaceutical and biotech companies. We leverage our significant experience with formulation development, analytical methods, manufacturing, and clinical packaging and labeling to move topical products quickly towards regulatory approval.
Topical Drug Product Design and Development Services
Topical Formulation Design and Development
- Pre-formulation studies (solubility, excipient compatibility, pH profiles)
- Prototype formulation design, development, and optimization specific for the disease state
- Accelerated stability and packaging compatibility studies (pH, viscosity, conductivity, water content, microscopy)
- Process development and scale-up
Drug Product Testing, Methods & Stability Studies
- Method development for assay of API in drug product (HPLC, UPLC)
- Analytical method validation (phase-appropriate from GLP through Phase III/commercial stage)
- In-process and finished product release testing
- Identification and quantitation of degradation products/related substances
- GMP stability studies (temperature- and humidity-controlled storage, ICH conditions)
- Accelerated stability testing, tables, and reports
- Extrapolation for shelf-life determination
Drug Product Manufacturing (gels, creams, ointments, solutions, sprays, pastes)
- Supplies for GLP studies (up to ~40 Kg)
- Supplies for GMP clinical studies (Phase I/II) with filling (tubes, vials, bottles, syringes)
Ophthalmic Product Development
- Feasibility and pre-formulation studies
- Development of prototype formulations with stability and packaging compatibility studies
- Assessment of API and product with terminal sterilization techniques
- Product manufacture and fill (R&D or GMP), followed by terminal sterilization
Clinical Packaging & Labeling
- GMP stability studies (temperature- and humidity-controlled storage, ICH conditions)
- Accelerated stability testing, tables, and reports
- Extrapolation for shelf-life determination