Cell and Gene Therapy (C&GT) is a fast-growing field, and that fast growth brings challenges to its development and manufacturing process. Implementing Process Analytical Technology (PAT) and Quality by Design (QbD) might be the answer to overcome some of those challenges. How? Let’s find out! PAT and QbD: a handful of benefits for C&GT There are many benefits that you can get from implementing PAT and QbD in your Cell and Gene Therapy process.   In fact, we might as well go for a list of what you can expect: An increase process knowledge and help you identify the Critical Qualit ..read more

The last few years have been full of advances in the field Advanced Therapy Medicinal Products (ATMPs). And, as any products that interfere in the health and well-being of patients, it requires a Quality Risk Management System. Which brings us to this blog post: why a Digital QRM System for ATMPs is a must have! How did we get here? We mentioned advances in the field of ATMPs. These advances have the shape of cellular and molecular biotechnology progress that affects gene therapy, somatic cell therapy and tissue engineering. Across the world, the ICH Q9 is the standard for Quality Risk Managem ..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? Let’s find out! The current model and its risks One of the paradigms of the pharmaceutical small-molecule industry is its definition of clinical programs. These programs are capable of establishing risk-benefits of a dosage and its delivery system on healthy individu ..read more