ASX-listed biotech PharmAust’s wholly owned subsidiary, Epichem, has become one of the first companies in Australia to receive an internationally recognised standard of quality assurance to support pharmaceutical drug manufacturing.
In a recent market update, the company said Epichem had gained the coveted ISO17034:2016 accreditation from The National Association of Testing Authorities, Australia.
This sets an exacting benchmark for the production of reference material, which is used to check the quality of products to validate analytical measurement methods, or for the calibration of instruments, making it a critical requirement for drug manufacturers.
Epichem already holds ISO 9001:2015 accreditation that proves its products and services were of consistent high quality.
ISO 9001:2015 is a globally recognised standard based on quality management principles including a strong customer focus, the motivation of top management, the process approach and continual improvement.
Epichem CEO Dr Martine Keenan said: “We are delighted that Epichem has gained accreditation to ISO17034:2016. This will strengthen alliances with our existing customers, expand our client base and distinguish our products from competitors by placing us in a more exclusive tier of reference standard manufacturers.”
Epichem provides hi-tech biological product and research services in chemistry and medical and has an impressive client list that is strewn across more than 33 nations. It has several global pharmaceutical players on that list and boasts a large team of PHDs.
The company generated revenues of $3m in the 2017 financial year.
Last month, Epichem was awarded a US$1.65 million contract extension to provide US based Unity Biotechnology with support on drug discovery projects, aimed at extending the amount of time that people can live disease free.
Epichem is also assisting Pharmaust with research on its promising anti-cancer drug Monepantel, which is slowly but surely ticking a lot of boxes along the path to commercialisation.
PharmAust has completed Phase 1 clinical trials with Monepantel in both humans and dogs diagnosed with solid tumours.
All trials achieved their primary clinical endpoints in terms of safety and reduction in key clinical biomarkers.
By Matt Birney
