This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical industry, focusing on using single-use technologies (SUT) in bioprocessing for monoclonal antibody (mAb) production. It aims to inform sustainable practices within the biopharmaceutical industry and to encourage the development of more sustainable disposable technologies.

This article describes the numerous activities in the commercial quality control (QC) network that aim to replace in vivo assays with alternative methods in the course of production and release. Specifically, three areas are considered: cell bank testing, pyrogen testing, and potency testing. 

In an era where advanced therapy medicinal products (ATMPs) are revolutionizing healthcare, the 2024 ISPE Pharma 4.0™ and Annex 1 Conference, taking place 10-11 December in Rome, Italy, and virtually, will feature a track titled, "How ATMPs Manufacturing can be Supported by Annex 1 and Digital Transformation."