Last October 21st took place our first 4TE talk, a 20-minute conversation where we invite remarkable people to talk about important topics for the Pharma and Biopharma industries. And our first guest was Stephan Krause, Head of Product Quality at AstraZeneca Biologics. If you missed it, don’t need to worry Read more…
The quick growth of the Cell and Gene Therapy created a great deal of enthusiasm in the biopharma industry. But, despite the merits they hold for patients, there are still some challenges when it comes to minimising their risks. We hope you have your seat belts fastened and be ready for the take-off. On today’s journey will share some 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…
Lisbon, October 12th: 4TE has become the most recent member of Health Cluster Portugal (HCP). HCP has the goal of making Portugal a competitive player in the research, design, development, manufacturing and marketing of products and services associated with health, targeting the most relevant international markets. Also, HCP promotes and Read more…
The most recent publication of ISPE Good Practice Guide on Knowledge Management (KM) brought once more to the attention the need to have the best practices established when it comes to KM Framework implementation. In this blog post, we’ll go through some concepts on Knowledge Management. So, if this is a topic of interest to you, stay with us! Let’s start with a Read more…
Who doesn’t like a good story? Well, we have another for you! This time, we want to tell you how we helped a company in the Post-Approval Change Management of a Legacy Product using a Retrospective QbD methodology. Are you curious about it? Let’s check this out. Let’s know what happened! The company in our story faced some issues in managing the Post-Approval Read more…
It’s 4TE story time! Today, we’ll talk about how we helped a company in accelerating the time-to-market of a drug product using a Quality by Design (QbD) framework. As usual, our characters are confidential, but we are sure that we’ll be able to give you all the key insights about it. Are you ready to go on an adventure? Let’s go! A Read more…
In our last blog posts about Continued Process Verification (CPV) you were able to know the benefits, challenges, and even how to do a CPV Implementation. However, there’s a lot to consider when it comes to take the step into Digital Continued Process Verification. That’s why it is important to Read more…
Making Post-Approval Changes can be a challenge. You have different timelines, different submission requirements and trouble optimising your processes. Because of that, this makes the knowledge of creating a post-approval change management (PACM) protocol all the more important. And that’s what this blog post is all about! In it, we’ll 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…