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Dow development laboratories, llc is a company specialized in topical drug product manufacturing and formulation. We take pride in providing top-notch services for topical formulation design.
Dow development laboratories, llc is a company specialized in topical drug product manufacturing and formulation. We take pride in providing top-notch services for topical formulation design.

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.

Services
Services

Topical Drug Product Design and Development Services

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
  • IVRT (in vitro release testing)
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Services

Drug Product Testing, Methods & Stability Studies

  • Method development for assay of API in drug product (HPLC, UPLC, LC/MS)
  • 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
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Services

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)
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Services

Clinical Packaging & Labeling

  • GMP stability studies (temperature- and humidity-controlled storage, ICH conditions)
  • Accelerated stability testing, tables, and reports
  • Extrapolation for shelf-life determination
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