The rapidly evolving biopharmaceutical industry is already delivering radical new products to treat and/or prevent a range of diseases. There is a healthy pipeline of innovator biologics in development and, as early patents expire, an emerging biosimilars market. The pace of development is relentless, and continues to uncover new and unique challenges when taking a complex biological molecule — usually a protein or protein-based — from promising drug candidate to commercially producible therapeutic product.
Collaboration between analytical instrument manufacturers and those at the front line of biopharmaceutical development is vital to optimise and commercialise essential measurement technologies. Analytical techniques that can be used throughout the drug development process, and follow the molecule from preformulation right through to manufacturing support, are especially prized. Their value lies not simply in the insight they provide into the molecule and its behaviour, but also in delivering consistent and directly comparable data that enable the rapid detection of any changes during development and manufacture.
A critical factor that can determine the successful development of a biomolecule as a therapeutic is its stability. Differential scanning calorimetry (DSC) is both the gold standard technique for stability characterisation and also a good exemplar of an analytical technology that is being shaped to more closely meet industry requirements, some aspects of which are examined in greater detail here.
Not yet a Subscriber?
This is a small extract of the full article which is available ONLY to premium content subscribers. Click below to get premium content on Manufacturing Chemist.
Subscribe now Already a subscriber? Sign in here.