Today, the pharmaceutical industry is facing a lot of pressure to meet the high demands of the customers and regulators. The market is rapidly changing and, as such, your product development needs to keep up with it. You can achieve this by accelerating the process scale-up and industrialisation with an Read more…
Tech Transfers, or Technology Transfers, usually imply that you’re moving the manufacture of a drug from one facility, one scale or one drug lifecycle phase to another. Which is why they are so important. When you switch facilities, you want to transfer the knowledge and reproduce the process smoothly. The Read more…
Today we want to take a fresh look into comparability for post-approval changes. How? We’re thinking of a unique multiparametric approach. This approach is aligned with the FDA’s tiered and totality-of-evidence concepts in biologic development. These concepts are helpful to compare biosimilar and reference products. But they can go beyond Read more…