Integrated Production Platforms
Biotechnology is a key 21st century technology. As such, biotechnological products are already changing our lives, for example as active pharmaceutical ingredients (APIs) in new medicines that facilitate the treatment of challenging diseases such as cancer. The number of such biopharmaceuticals has increased over the last years, accounting for about 30% of all new medicines approved by the regulatory authorities. But before any such medicines enter the market, they must undergo an extensive development process comprising API design, proof of concept, process development and scale up, production under good manufacturing practice (GMP) conditions, clinical trials and regulatory approval. Although such processes may involve different steps and unit operations, they all trace back to acommon origin: a brilliant idea for a new API.