In the pharmaceutical world, the term ‘innovation’ often refers to ideas that unlock new markets and/or new processes and technologies. It also encapsulates new or advanced ways of looking at and using existing technologies. This can be, for example, an improved RABS cleanroom concept that combines the advantages of isolator and RABS technology in order to better meet requirements in quality, safety and flexibility. The core of the approach is a fast cycle and fully automated decontamination of the cleanroom using hydrogen peroxide (H2O2), resulting from a high level of process innovation.
Forward thinking contract development manufacturing organizations (CDMO’s) are restless when it comes to the field of innovation. They become increasingly more so as drug development and manufacturing increases in complexity and competition heats up. A CDMO must be completely dynamic to remain successful. Furthermore, on a corporate-wide basis the company must be active in the innovation field, supported by running dedicated departments to introduce and to pursue a holistic innovation management system. Their customers expect cutting-edge products and services, processes and technologies, all of which require innovation and drive. A continuous, close and open dialogue with customers about present and future product, service, and process needs with regards to drug product development, manufacturing and supply is essential for growth and sustainability of the CDMO as well as the partnership itself.
Protecting your assets and being open to new roads
Innovation comes with a price. The first step is time consuming and often costly to implement. It is also high risk. As such, it is essential to protect your work. This is where intellectual property management becomes crucial. Patents that belong to your inventions must be properly filed and protected.
Also, third-party inventions or research in the form of collaborations with research institutes or other industrial companies should not be overlooked. Being active and involved across many fields is imperative to success since a variety of relationships can be a major stimulator of innovation. Efforts undertaken with research experts in their respective field, industry leaders, best practice leaders as well as cross-industry collaborations can be amply rewarding and significantly contribute to innovation. Nevertheless, it should never be forgotten that these efforts must be guarded through patent protection of the resulting intellectual property.
There is no doubt that innovation is a necessity, and it is essential that the industry adapt if it is to survive. However, within the current regulatory framework realizing innovations is sometimes not an easy task, with some companies being more open to being innovative than others. For example, a large pharmaceutical company sometimes may be torn between choosing an innovative versus a conservative approach. Quite often, the first to innovate may be seen as the one taking risks and facing numerous roadblocks to success.
When it comes to flexibility and efficiency, however, CDMO’s must lead the way and act in a more innovative manner than anywhere else. After all, the very nature of the business model of a CDMO is to have numerous customers with several drug products manufactured on one single line. Still other examples include the trend towards smaller product and batch sizes, increased time-to-market expectations by customers, and ever-more complex productions processes such as those involved with biologics.
Innovation is like oxygen to the injectable industry. Without it, survival may be difficult. How much innovation is necessary, however, is subject to the situation. Who will take the riskier path to achieve success is often the question. Digitalization, individualization and alternative delivery methods and systems are some of today’s innovation conversations, but after these topics have been addressed, it is anyone’s guess what will be next. Nevertheless, new approaches and alternatives will emerge, of that there is little doubt.
Vetter Pharma-Fertigung GmbH & Co. KG
Claudia Roth is vice president of innovation management at Vetter Pharma-Fertigung GmbH & Co. KG. Since 2015, Dr. Roth has headed up the newly created Innovation Management division at Vetter.