Regulatory Sciences in Biopharmaceutical Drug Development
Biopharmaceuticals are not only the fasted growing area in drug development, but also the most complex concerning CMC, mode of action and safety. Therefore the scientific and technical approaches develop very fast.
Despite efforts of harmonization in the field of biopharmaceutical development and registration, approval of biopharmaceuticals is based on a case by case approach reflecting drug specific scientific concepts. The challenge of biopharmaceutical drug development is the need to scientifically interpret regulatory guidelines in very close context to the molecular structure and mode of action characteristics of the molecule of interest.
In collaboration with our strategic partner Dr. Regenold GmbH, Target BioScience supports this high demand for “regulatory sciences” by combining worldwide regulatory experience with a continuous growing network of cutting edge scientists from academia and industry. This regulatory science approach builds the backbone in biopharmaceutical drug development and throughout the lifecycle of the product including:
- Antibodies and antibody fragments
- Somatic cells, gene therapies, tissue engineered products (ATMPs)
- Recombinant vaccines