Glatt develops high-performance technologies and processes for the pharmaceutical, food, animal feed, fine chemicals and biotechnology industries. In the pharmaceutical industry, the company is particularly well known for its fluid bed systems, handling systems and biotechnology.
So what are ATMPs? The abbreviation stands for “Advanced Therapy Medicinal Product”. ATMPs, or advanced therapy medicinal products, are a special innovative class of drugs based on biotechnological and genetic engineering processes. They are used to treat very serious diseases such as cancer or genetic defects.
In his presentation, Dirk Steinhäuser (Glatt Ingenieurtechnik) presented the requirements and solution concepts for how the flexible and modular production of ATMPs can be technically implemented. A further aim of the concepts presented is therefore that the production plant can be used not just for one product, but for several products. This is highly relevant for the field of ATMPs because such concepts increase the product availability of innovative drugs.
For flexible and modular implementation, Mr. Steinhäuser presented several layout concepts in which the use of flexible cleanrooms (production compartments) is planned. These production rooms are constructed in modular units that can be easily expanded, reduced in size or reconfigured to meet different production requirements. The use of such cleanrooms therefore also enables rapid changeover between different production lines or processes (fast changeover systems). These aspects are particularly important for the manufacture of ATMPs due to the many manual production steps involved.
Furthermore, when implementing such concepts, the focus is primarily on single-use technologies (single-use systems), as these offer greater flexibility with regard to the various production processes and reduce the effort required for cleaning/cleaning validation.
Glatt works with several pharmaceutical companies and has already implemented such systems in a number of projects.
Copyright: Wiley-VCH GmbH
Copyright: Vogel Communications Group
Copyright: Vogel Communications Group