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.
In January 2023, Acrux received a positive outcome from an FDA Remote Regulatory Assessment (RAA).The FDA concluded that “we did not identify objectionable conditions and thus do not have any observations…”. The FDA RRA was carried out by the Division of Generic Drugs Study Integrity (DGDSI), Office of Study Integrity and Surveillance (OSIS), which forms part of Center for Drug Evaluation and Research (CDER). As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. The RRA was based on an in-vitro bioequivalence study that Acrux conducted and submitted to the FDA as part of an Abbreviated New Drug Application (ANDA) that is currently under FDA review.
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.