Speed to market is a major priority for life sciences companies and this is going to be a featured topic during the 2023 ISPE Biotechnology Conference. More than ever before, biotechnology companies are pushing for exponential growth by expediting the scalability of manufacturing processes and the use of different modalities. This can significantly accelerate patient access to life-saving...
Industries around the world are working to reach carbon neutrality. By reducing greenhouse gas emissions or removing carbon dioxide from the atmosphere, companies can effectively make up for the emissions they produce elsewhere. Think of it like planting a tree in one place for every tree you cut down elsewhere. In theory, if you plant as many trees as you cut down, you will reach “net-zero...
When a Project Manager (PM) joins a new qualification project for a new production plant, the first thing to do is to gather information so that you will know the scope of the project very well: all the systems, equipment and services that are part of it and the scopes of the different qualification phases. In addition, the key members of each area and their level of support must be...
The use of robotics to manufacture Advanced Therapy and Medicinal Products (ATMP) solves many challenges, including significantly limiting exposure to human generated contamination. There are steps to mitigate contamination points but with the strong endorsements recently made within the current revision to Annex 1 encouraging the use of robotics (Section 8.9),1
As the biopharmaceutical industry grapples with faster commercialization of new drugs, along with an increased focused on sustainability, process simulation has never been more relevant. Whether for risk assessment or optimization, process simulation aims to represent a chemical or biochemical process by modeling the governing mechanisms that affect quality, yield, throughput, environmental...
