Cleanroom Industry Insights

The term Advanced Therapy Medicinal Products (ATMPs) officially emerged in 2007, with the adoption of Regulation (EC) No 1394/2007 by the European Commission. This regulation established a legal framework for these innovative therapies in the European Union.

However, the concept and development of ATMPs have a more extended history, tracing back to earlier forms of cell and gene therapies that emerged in the 1980s and 1990s. These earlier therapies, often called gene therapy, somatic cell therapy, or tissue-engineered therapies, faced regulatory challenges due to their novelty and complexity.

The introduction of the ATMP terminology in 2007 represented a significant step forward by recognizing these therapies as a distinct category with specific regulatory requirements. This categorization facilitated their development and approval by providing a clear framework for manufacturers and regulators.

If you want to build a cleanspace, there’s a critical choice from the start – modular or standard construction. While both options serve the same purpose of maintaining pristine conditions, they differ in their approach and advantages. In this article, we’ll dive into the fascinating realm of cleanroom classifications and explore the unique qualities that set modular cleanrooms apart from their traditional counterparts. 

Cleanroom classifications constitute a vital framework within the field of controlled environments, serving as a standardized system for categorizing and defining the cleanliness and contamination control levels of cleanrooms. 

These classifications are essential for ensuring product quality, safety, and regulatory compliance across various industries, including pharmaceuticals, electronics manufacturing, aerospace, and healthcare. Here is a comprehensive overview of cleanroom classifications:

Modular cleanrooms significantly expedite the deployment of new therapies in the cell and gene therapy industry. Their prefabricated nature allows for rapid assembly and implementation, a crucial advantage in a field where time is of the essence. This rapid deployment directly translates into a shorter time to market for new therapies, thus facilitating timely access to innovative treatments. Moreover, the inherent flexibility of modular cleanrooms supports swift adaptation to evolving research needs and production scales, ensuring that the development and scaling up of new therapies can progress without significant delays.