Continuity, persistence, and innovative spirit payoff: In recent years, L.B. Bohle Maschinen und Verfahren GmbH has invested several million euros in the development of new machines and processes for the continuous manufacturing of pharmaceutical solids. “At the 2nd Innovation Days of L.B. Bohle and our partner, KORSCH AG, we will not only talk about the latest developments. We will also present the first complete plant as a reference in our new Plant 4,” said Executive Director Tim Remmert in his welcome address to the 90 participants on Wednesday.
Just a few years ago, many in the pharmaceutical industry considered continuous manufacturing, or the continuous production of tablets, to be just another technology that first raised great expectations, then got hyped, but failed just as spectacularly in practice. “Many technologies came and left. But with continuous manufacturing, things turned out differently,” reported Professor Peter Kleinebudde of Heinrich Heine University in Düsseldorf at the start of the two-day symposium.
“Plateau of productivity” reached
This technology also went through the usual curve of initial euphoria, high expectations, disillusionment, crash, and abandonment by many players. However, the professor believes that the persistence of innovation drivers such as L.B. Bohle has ensured that continuous manufacturing will reach a “plateau of productivity” where the technology is now making a breakthrough. “The goal here is not that the entire manufacturing process has to be 100 percent continuous,” Kleinebudde explained. It could also be just individual process steps. Depending on the product requirement, he said, continuous manufacturing varies in intensity.
Dr. Carsten Schmidt (Head of Drug Product Development, Merck Healthcare KGaA, Darmstadt) also highlighted persistence, innovative spirit and short decision-making processes at L.B. Bohle as success factors. After an initial visit and discussions in 2016, Merck had initially decided against a project with L.B. Bohle in 2017. “But Lorenz Bohle, chairman of the foundation at L.B. Bohle, personally stayed on. He wanted to know why we made the decision we did,” Dr. Schmidt recalls. The feedback resulted in a constructive exchange, and in 2018 the first prototype was tested. The experts now inspected the result of further joint development work during the seminar: a complete production line for the continuous manufacture of tablets.
Intensive knowledge exchange
The heart of the complete line is the QbCon® 1 from L.B. Bohle for continuous wet granulation and drying. Together with a mixing and dosing unit (Gericke AG), it is completely enclosed by an isolator from Franz Ziel GmbH. In addition, there is a BTS 100 screen, a XL 100 WipCon® tablet press from KORSCH AG and a KOCO® 25 semi-continuous coater. The system is fed by two HS 400 automated lifting columns.
During the two-day Innovation Days, experts from other companies, such as KORSCH AG, Gericke AG and Franz Ziel GmbH, also presented the technical aspects of their special machines and their integration into continuous processes. At the end of the Innovation Days, host Tim Remmert and company founder Lorenz Bohle expressed their great satisfaction with the intensive exchange of knowledge among the pharmaceutical experts. The Innovation Days format will certainly be continued in the future. “The response was positive throughout and we are very pleased to have not only informed the participants about our processes and equipment, but to have inspired them,” concluded Tim Remmert.