Facilities & Capabilities

Facilities and Capabilities

Our facility is diverse and allows end to end integration from clinical research to manufacture.

Research and Development Focus

  • Onsite laboratories and GMP licenced manufacturing facility
  • Early development process comprises:
    • Feasibility analysis based on drug properties and desired product delivery characteristics
    • Analytical method development
    • In-vitro testing of formulations on human skin samples
    • Stability testing of potential formulations
    • In-vivo testing of pharmacokinetics for short-listed formulations
    • Selection of formulation(s) for pivotal trials
      • In-vivo testing usually conducted in Australian Phase I clinical units
      • Phase II clinical trials either in Australia and/or internationally
      • Phase III clinical trials usually conducted in the USA and Europe (key target markets)
  • Development for generic medicines refers matching the formulation to a specified reference product
    • It involves the use of many analytical tools and techniques to characterise and confirm the composition is the same as the reference product
  • Manufacturing and testing of product for clinical trials in Acrux’s GMP facility and laboratory
    • Acrux has a current TGA licence for manufacture of transdermal and transmucosal products for Phase II & III clinical trials
  • Mid to later stage development activities include:
    • Analytical method development and validation
    • Container closure selection
    • Applicator or device development
    • Extractables and leachables testing
    • Stability testing
    • Manufacturing scale-up and technical transfer to commercial-scale facilities
    • Performing CMC activities, studies and reports for regulatory submissions