Continued Process Verification (CPV) is the continued collection and analysis of data that assures your process is in a state of control. CPV Implementation is important because you can then monitor product quality in real-time. Efficiently. In this blog post we write about why implementing a CPV plan in your Read more…
4TE has been recognised as a top Innovator (status of “INOVADORA“) by COTEC Portugal. Lisbon, PT: On August 19th, 4TE has been recognised as a top Innovator (status of “INOVADORA”) by COTEC Portugal, a distinction that recognises national companies with high innovative performance. 4TE’s Chairman and Founder, José Cardoso de Menezes, shared his thoughts about this distinguished status of “Innovative SME Read more…
In this blog post we will talk about the performance Risk Management of Sterilising Filtration. Do you want to know more? Keep on reading! The problem on Sterilising Filtration Risk Assessment In 2017, the Parenteral Drug Association (PDA) and the BioPhorum formed a consortium with a mission. That mission was Read more…
This is a 4TE Story on how we helped a company finding the Root-Cause in mAB Production. Would you like to know more? Keep reading! Imagine that you’re producing Monoclonal Antibody (mAB) products, and something goes wrong. You spend time, energy and resources trying to find the problem without success. Read more…
Subjectivity in Risk Assessments and Quality Risk Management (QRM) outputs has been under the spotlight recently. In this post we will explore why, how, and what are the tools that you can use to minimize it. Current regulatory context Since the publication of ICH Q9 in 2005, it became the Read more…
In this blogpost, we want to make you think about the application of the Quality By Design for Cell & Gene Therapies. Over the past century, lifecycle management of biotechnology products and biopharmaceutical industry has been founded on principles from the pharmaceutical small-molecule industry. But are they suitable for it? Read more…
When we talk about software, the saying “garbage in garbage out” applies both for data and its requirements. And if you write a poor user requirements specification, the result will be a poor software. It’s not a wild conclusion: feeding a software with bad data will result in badly processed Read more…
The basis for Continuous Manufacturing (CM) are modern monitoring and controls. But, if we want to make full use of them, we need advanced analytics applications. And this is where Process Analytical Technology (PAT) come into play! Do you want to know more about the topic? Then this post is Read more…
You may have heard of the perfusion bioreactors importance for the development of continuous manufacturing related to cell culture. We want to share how 4TE helped optimising a perfusion cell culture medium for a Life Sciences company on this topic. What happened? They had identified that their Perfusion Cell Culture Medium was underperforming in terms Read more…