Founded in 1995 in response to a growing need for outsourced pharmaceutical stability testing, A&M STABTEST has developed into a broad analytical service provider. In this interview with The International Pharmaceutical Industry Journal, the company looks back at its origins and discusses how increasingly complex drug products, inhalation therapies, new analytical technologies and digitalisation are changing the requirements for pharmaceutical analytics.
Please introduce A&M STABTEST. How was the company founded, and which analytical testing services does the company provide to the pharmaceutical industry today?
The story of A&M STABTEST began with four analytical scientists who studied together at the University of Cologne and later worked in the pharmaceutical industry, gaining first-hand experience of its analytical and regulatory requirements. In the early 1990s, new ICH guidelines and increasing post-authorisation requirements created a growing need for stability testing, while external capacity remained limited. The four scientists recognised this gap and, in 1995, founded A&M STABTEST as one of the first German GMP-certified provider to offer pharmaceutical analytics and stability testing as a strategic outsourcing solution.
GMP has been at the core of the company from the beginning. A&M STABTEST has been GMP-certified since its foundation and is operating in an international regulatory environment since many years, including regular inspections by the EMA, the FDA and other regulatory authorities.
From these beginnings, the company has developed considerably. Today, A&M STABTEST employs nearly 400 people across two sites in Bergheim and Mainz and provides analytical services along the pharmaceutical product lifecycle. Our work ranges from API and excipients testing through process performance qualification (PPQ) to finished pharmaceutical products and combination products. It also includes packaging and drug-device testing, including extractables and leachables, material characterisation, container closure integrity and functional testing.
Our scientific scope has expanded accordingly. In addition to classical pharmaceutical analytics and stability testing, we provide analytical method development, transfer and validation, quality control and release testing, mass spectrometry, bioassays, biopharmaceutical characterisation and specialised inhalation analytics. We work with classical small molecules as well as biological molecules, complex formulations and new therapeutic approaches.
