Biotech and active pharmaceutical ingredients
Biotech pipelines are booming with new products and treat¬ments calling for flexible and efficient processes. Establishing and maintaining fully compliant and cost-effective manufacturing capabilities is as challenging as ever.
Biotech, and particularly the field of biopharmaceuticals, has been growing fast and will constitute more than 50% of the pharmaceutical drug market by 2020.
Biopharmaceuticals include a broad range of product types requiring different production technologies. Most manufacturing methods utilise either microbial or mammalian expression systems, but other systems are utilised for specialised products such as vaccines. Additionally, the industry is facing new challenges, based on the introduction of new and even more complex products such as antibody-drug conjugates (ADC), which require facilities that are capable of handling biologics and potentially very potent (toxic) small molecule products in the same facilities.
As such, the industry is moving away from a state of stable development of biopharmaceutical products for especially diabetes (insulin), cancer, arthritis (monoclonal antibodies) and other special diseases. The next generation of biopharmaceutical products require more complex manufacturing methods. A large portion of the products, e.g. orphan drugs or immunotherapy, is produced in much smaller quantities. Moreover, many existing facilities are more than 20 years old, making them overdue for an upgrade to meet both current and future requirements.