Facilities and Capabilities
With onsite laboratories and a GMP manufacturing facility, Acrux has the capabilities and facilities for early development through to clinical trial manufacture. We hold a TGA clinical trial manufacturing licence.
Research and Development Focus
Acrux employs Quality by Design (QbD) principles in its product development.
QbD is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and controls, based on sound science and quality risk management.
Acrux employs highly skilled formulation scientists and analytical chemists to develop topical and transdermal products from inception where the Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) are established and defined through to regulatory dossier submission. This pharmaceutical development process includes the following:
- Analytical tools and techniques to reverse engineer and characterise the composition of reference products
- Analytical method development and validation
- Intellectual Property analysis
- Formulation development and small scale manufacture
- In-vitro testing of formulations including In Vitro Release Testing (IVRT) and In Vitro Permeation Testing (IVPT) on human skin
- Stability testing of prototype formulations
- Container closure selection and development
- CMC studies and reports for regulatory submissions
- Technical Transfer and project management of contract manufacturers
- Compilation of dossier including development reports for submission to regulatory agencies such as the FDA.