Introducing new pumps and systems into the pharmaceutical industry has never been easy. To gain acceptance even for a process improvement is a long run through all company hierarchies, unless it shows significant cost or process improvements. In addition to the market's natural conservatism, there is a wall of legislation surrounding drug safety standards that renders it almost impossible to alter an approved production process once it has been verified by the relevant international standards and approved from authorities.
Nevertheless, drug manufacturers are constantly looking for ways to improve on system quality and efficiency. And, given the difficulty of implementing change, they are determined to make the most of any new technologies they do decide to invest in.
"The industry is evolving; it's no longer feasible to simply offer customers stock systems and products," says Joachim Regel, life sciences sales manager for LEWA. "Pharmaceutical manufacturers are entering into a dialogue with us as a pumps and systems manufacturer. We look into their processes, offer our expertise, then they decide on a solution that we create for their dedicated process."
"Manufacturers are entering into a dialogue with us as a pumps and systems manufacturer. We look into their processes, offer our expertise, then they decide on a solution that we create."
Being able to meet the individual demands of pharmaceutical manufacturers requires LEWA to have an excellent knowledge of the current market, almost to the point of second guessing what companies will be looking for. To help stay ahead of the trend, LEWA has partnered with a number of universities, research institutes and industry firms, all with the common goal of developing innovative pump system products.
"We are constantly analysing the biopharmaceutical and pharmaceutical markets to look for new areas to explore," says Regel. "Once we have a general idea, we develop a sample application for possible use in that area. So for example, one of our broader interests is pump efficiency and precision, and within that field, we are particularly concerned with minimising energy usage and enhancing our product's green credentials."
Another important focus area for LEWA has seen the industry shift away from pharmaceutical batch production towards continuous highly efficient manufacturing processes. LEWA and its partners, Bayer Technology Services, have been pooling their knowledge on the subject of SMB technologies.
"Continuous production processes require equipment that is extremely robust," says Regel. "It doesn't have to be at the highest technical level, but it must be able to deliver the same high performance in process for long periods of time. It should also be extremely reliable, and have a high level of reproducibility."
These qualities are central to one of LEWA's most recent products, the intellidrive diaphragm-metering pump. Using a dynamic servomotor, the intellidrive allows users to modulate pump stroke to their individual system and process requirements, eliminating the traditional need for stroke adjustment.
"The servomotor brings a level of flexibility that will allow manufacturing processes to run a lot more precisely at validated conditions," says Regel. "We've also integrated the technology into our chromatography process system, the LEWA EcoPrime, which is used in the purification of biopharmaceuticals as well as APIs."
A combination of state-of-the-art functionalities, the EcoPrime can act as either a buffer dilution skid or chromatography system. The integrated intellidrive technology increases the precision of the pumps to ±0.5%, maximises their flow range, and brings low pulsation flow and high accuracy. It allows the intregration of buffer dilution into a chromatography system. Crucially, it also bridges the gap between R&D, process development and production functions, covering all three stages.
"We have our own water-based data that demonstrates the precision of the EcoPrime system, as well as the higher reproducibility of the process set points," says Regel. "Our overall goal is that our customers will be able to produce biomolecules with much higher purity."
LEWA is focused on maintaining its position at the forefront of technological innovation. "There's been a huge expansion in research and development across the industry in recent years, and we're determined to stay ahead of the trend," says Regel. "We have a number of ongoing projects at the moment, focusing on the core areas of precision, efficiency, flexibility and, above all, reliability as an integrated concept for the individual customer's situation."