The new ICH Q13 guideline is almost here! The guideline on continuous manufacturing (CM) is currently under public consultation and the general deadline for comments is end of 2021. We, as 4TE, have been actively involved on the public consultation phase. And, because of that, we thought of talking a Read more…
Currently, the industry is facing a very high demand for biologics such as large proteins or vaccines. Because of that, bringing a Continuous Manufacturing (CM) process to these types of products, will improve their quality and deliver many business gains to your company. So, with this blog post, we want to give you a little review about Read more…
Continuous Manufacturing as a subject and an opportunity keeps getting hotter and hotter. So, it only makes sense that we approach the topic of Continuous Manufacturing and MSPC. Why? Because the later greatly helps the former! Are the classical univariate statistical controls too… classic? When you work with Batch production, 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…