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A&M STABTEST

A&M STABTEST is one of Europe’s leading providers of pharmaceutical analysis services. In 1995 we set out to be recognized as a reliable partner for stability and release testing of pharmaceuticals. In order to achieve this, it became clear that we needed to focus our service offering solely on the pharmaceutical industry to implement and maintain analytical services at the highest quality standard. Today, over 25 years later with over 350 staff at two sites, we stay true to the original idea of exclusively providing services to the pharmaceutical industry.

This focus enables us to actively engage with our clients to not only provide analytical solutions for the drugs that are produced today but also to have high-quality analytical solutions ready for innovative therapeutics in development for the future. In 1998 this proactiveness earned A&M STABTEST the contract to provide the data for the registration stability study of one of the world’s first Biosimilars, for which we still today perform release testing. This project marked the cornerstone of our specialized Biopharma Competence Centre located in Bergheim near Cologne. At the Biopharma Competence Centre, we aim to offer all required services for QC-testing of Biologics from stability storage, instrumental and functional biological testing, to testing of primary packaging materials under one roof. This enables A&M to maintain constant quality overall services provided, efficient communication internally and with clients, minimizes the need for and the risks involved with sample shipments and reduces the overall costs of services we provide for our clients.

From the beginning, we believed in the analytical versatility of mass spectrometry. First, as an efficient tool to identify impurities and later to characterise post-translational modifications in proteins and to determine differences in the modification profile during process development, and transfer of production processes and to investigate biosimilarity. A&M STABTEST´s GMP-compliant mass spectrometry unit is divided into two specialized subgroups, one tasked with protein characterization and the other with leachable studies of primary packaging and single-use materials of production-related materials. Protein reactive extractables which are often overlooked in standard extraction studies have been an area of research in our company in the past and which is now becoming an industry-standard in extraction studies.

Our Mainz site is specialized in small molecule drug testing. These are considered as well established, however, we are seeing more novel formulations, enabling new routes of administration of established drugs and drug substances, that were previously thought undruggable due to their poor bioavailability, being developed. We offer more than 25 years of experience in developing robust QC methods making these novel formulations accessible to established analytical techniques.

One particular area of specialization is orally inhaled and nasal products. These products are attractive because of the direct delivery of the drug to the target tissue and having immediate therapeutic effect by generally minimizing systemic exposure. However, these products are challenging to analyze and require specialized equipment, a strictly controlled laboratory environment (temperature and humidity), and highly trained staff. In the past 10 years, we have developed A&M STABTEST into the largest analytical service provider for the analysis of these types of products in continental Europe.

Veterinary drugs have been a strong driver of growth in the past years. Changes to the EU directive for veterinary medicinal products have changed national laws related to veterinary drugs. To be compliant it is now mandatory to have a manufacturing license for GMP analysis of these products. A&M STABTEST has been granted a license to continue its work in this field.

Currently, A&M is seeking to build expertise for the analysis of so-called Advanced Therapy Medicinal Products (ATMPs). We have implemented an ATMP-Taskforce, which together with our clients regularly discusses analytical and regulatory challenges faced with these new products. Our ATMP-Taskforce is a multidisciplinary team enabling us to tackle new challenges from different angles to develop suitable solutions for QC analytical for when our clients need them.

To offer our services exclusively to the drug developing and producing side of the pharmaceutical industry allows us to focus our quality system solely on cGMP requirements. This offers the advantage, that we do not need to find compromises to incorporate different rules and regulations into our quality system. Furthermore, this makes our QA- and laboratory staff more efficient when navigating the cGMP landscape, causing fewer compliance issues and timely reporting of registration-relevant data. The high-quality standard that we are able to maintain by only focusing on cGMP compliance has earned us a flawless audit and inspection record with our client as well as with national and international pharmaceutical regulators.

A&M STABTEST´s employees, managers, and owners are dedicated to serving our clients with analytical services at the highest quality standard and patients worldwide with safe and efficacious medicinal products with Analytics Made in Germany.