Digital Twin

Digital Twin (DT): a step forward for the biomanufacturing industry

These days, Digital Twin is under the spotlight of the biomanufacturing industry when it comes to industry 4.0.  In this week’s blog post, we’ll share some thoughts about the challenges of the biomanufacturing industry in their digitalisation efforts. We will then see how the Digital Twin can become key to predict and optimise process behaviour and product quality, across the Read more…

Challenges on Comparability Studies on Early Development Stages

During biopharma process development, there are often process changes that occur between non-clinical and clinical phases. When it comes to early development stages, Comparability Studies can be challenging.   If you are facing this type of problem, we’ve got the perfect reading for you! This blog post goes over the key aspects of developing solid comparability assessments Read more…

Analytical QbD

Is Analytical QbD the future of Method Development?

By now, we all know that Quality by Design (QbD) is essential to deliver safe and effective medicines. Because of that, the Pharma Industry is trying to adapt this methodology to Analytic Methods development. And it’s trying to do that by building quality into the design of an analytical test method.  In this blog post, we’ll give you an overview about what is Analytical QbD (AQbD) and answer this Read more…