Rapid advances in pharma and biopharma drug development are resulting in an increasing number of complex and niche therapies. This evolution is impacting manufacturing processes and equipment needs. The demand for flexibility continues to be the driving force behind the latest equipment. Small batches of specialized drug products, such as highly potent and cytotoxic drugs that require containment, various drug delivery systems, continuous manufacturing, and digitization, are among the main factors impacting manufacturing and equipment. –KB

Contract Pharma: What pharma/biopharma trends are impacting manufacturing equipment?
 
Andreas Mattern: The pharmaceutical industry is changing and developing at an unprecedented pace. On the one hand, important developments in biological agents, for instance for the treatment of cancer or orphan diseases, are entering the market. On the other hand, the development of continuous manufacturing equipment for OSD is opening new potential for optimum API dosage and faster time-to-market. Moreover, digitization is also gradually entering the world of pharmaceutical production and is about to change the way we work significantly.
 
CP: What capabilities do clients look for? 
 
AM: New biological developments call for flexible equipment that can handle ever smaller batches, while adapting to new products and packaging formats quickly. However, pharmaceutical manufacturers are not simply looking for the one machine. They are looking for a partner who can accompany them throughout their projects. This can start as early as in the R&D phase and go all the way to production and packaging as well as the underlying software requirements, qualification and validation support and service packages.
 
Consequently, the focus has shifted from merely technology-driven projects to complete solutions – including profound market expertise, innovative concepts and the flexibility to adapt to very specific and unique requirements. Such projects require a lot of time, experience and motivation.
 
CP: Are there any specific challenges clients are looking to overcome? 
 
AM: Digitization, Industry 4.0 or IoT – no matter what you want to call it, it’s all about using the existing data to optimize processes, make them more transparent and more efficient. The pharmaceutical industry must overcome specific challenges compared to other industries because of the very strict regulations regarding safety and product quality. Nevertheless, we are currently implementing a number of projects and are convinced that this is only the first step in very important developments.
 
In digitization projects, the first step consists in making the existing data visible in the first place. Our “Pharma i 4.0 Starter Edition” launched at Achema 2018 provides plant operators with essential data on their OEE, for condition monitoring of plant status or processes, and on important events like alarms or downtimes, simply and in real time. The Pharma i 4.0 Starter Edition not only monitors single machines, but also several lines simultaneously. Once the data is available, profound data analyses, for instance Bosch’s Data Mining service, can help to identify completely new potential for higher production transparency and optimization. Data mining makes it possible to assess information more effectively to identify and remedy the root causes of faults. In general, the data from two production batches is already sufficient to draw first conclusions. The more data is available for evaluation over a longer period, the more details will come to light.
 
CP: What are some of the latest advances in manufacturing equipment? 
 
AM: Another topic, that goes hand in hand with the development of more biopharmaceuticals is product and operator safety. In the production of OSD forms, the need for small batch equipment with appropriate containment has also evolved in parallel with the high potency of the drugs. For instance, the new Bosch GKF 720 capsule filling machine has been developed according to customers’ demands for OEB5 containment that ensures the highest protection for the operator, machine and product, while its minimal water requirements, 100% defective capsule detection and compact design translate into additional cost savings.
 
As mentioned before, the development of continuous manufacturing equipment for OSD is opening new potential for optimum API dosage and faster time-to-market. After the launch of our new Xelum platform in 2017, we now introduced the new Xelum R&D to the market. The Xelum system doses mixes and granulates individual packages, so-called X-keys, which continuously run through the process chain and are removed successively from the machine into bins. This way, even smallest amounts of APIs of less than one percent can be dosed precisely. Just like the production unit, it relies on the unique and proven technology developed by the Bosch subsidiary Hüttlin: instead of the usual twin screw granulators, the Xelum platform works with well-established fluid bed processors for optimum granule quality. The Xelum R&D will go on a “world tour” in 2019, starting with Interphex in New York, continuing via Powtech in Nuremberg, CPhI/P-MEC Frankfurt and Pharmtech in Moscow.