Our specialised team provides independent medicine testing and analytical services to local and international clients. Based at our analytical chemistry and microbiological laboratories at ESR’s Kenepuru Science Centre in Wellington, we are also the primary provider of therapeutic product testing for the Ministry of Health (Medsafe (external link) ) as part of their role in the continuous monitoring of the safety of medicines on the New Zealand market.
Our Pharmaceutical team tests a wide range of products against international pharmacopoeial (BP, Ph Eur, USP), or other requirements, to ensure quality and safety. We screen and test for counterfeit medicines and products suspected of containing undeclared medicines.
We perform analysis for local manufacturers and importers, biotechnology companies and clinical trial organisations and can test raw materials (active ingredients), finished products, natural health products (including herbal and complementary medicines), as well as medical devices and cosmetics.
ESR’s Pharmaceutical programme is certified by the Ministry of Health (Medsafe) in compliance with the New Zealand Code of Good Manufacturing Practice (GMP) (external link) and the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) (external link) .
Our secure, dedicated Stability Facility is one of the very few GMP-certified facilities available in Australasia. We offer storage of products for the determination of expiry date, based on ICH guidelines (external link) , within temperature and humidity controlled chambers. Our clients use our stability storage services for products and material during development and as part of the on-going quality control of established products. We are also able to assist in the development of stability trial protocols to ensure compliance with international regulatory requirements.
Endotoxin testing (LAL test)
Endotoxins are toxins produced by certain bacteria that are known to cause fevers and disease when injected into the bloodstream. Injectable medicines are therefore tested to ensure they are endotoxin free. ESR uses the Endosafe® - PTS (Portable Test System) - a rapid testing system which includes assays for quick and quantitative endotoxin detection and analysis.
The Endosafe® - PTS endotoxin test was developed Charles River Laboratories and is based on the limulous amoebocyte lysate test (LAL test). This test uses the LAL enzymes from the blood cells of the Atlantic horseshoe crab to bind and inactivate endotoxin from invading bacteria. Atlantic horseshoe crabs are native to South Carolina, and are protected to prevent over-harvesting. Charles River maintains a sustainable blood harvesting programme for obtaining the blood from these special creatures. Find out more about the important role that horseshoe crab blood plays in saving lives (external link) .