Continuous manufacturing doesn't have to be complicated


GEA experts recently discussed the advantages of continuous pharmaceutical manufacturing and the benefits of understanding its target markets in South Korea

GEA at the 2019 PRADA-GEA/SKKU Joint Workium(L–R): Jay Kim, GEA Sales in Business Area Solution / Pharmaceutical Business; Richard Steiner, GEA Business Development Manager; and Dr Jim Holman, GEA Head of Technology Management for Pharma Solids (Photo: GEA)

As part of GEA’s ongoing collaboration with South Korea’s Sungkyunkwan University (SKKU) in Suwon, Richard Steiner, Business Development Manager, and Dr Jim Holman, Head of Technology Management for Pharma Solids, combined several customer visits with presentations at the 2019 PRADA-GEA/SKKU Joint Workium on pharmaceutical technology for solid dosage forms.

“Interest in continuous processing technology is growing in this area,” said Holman. “Many local organisations are currently taking a wait-and-watch approach, gathering as much information as possible before committing to the implementation of CM.”

GEA must accommodate the fact that a great deal of pharmaceutical business in South Korea is generic products

Holman explained that this is because there are still some regulatory hurdles to overcome in this part of the world and, with this in mind, one of GEA’s key objectives with this visit was to tackle the misunderstanding that ‘continuous equals complexity.’

“Yes, we can provide top-of-the-range, fully integrated manufacturing systems that convert powder to coated tablets in a single line, but we can also supply ‘bin-to-bin’ solutions according to specific customer requirements,” Holman clarified.

Steiner said that GEA has to be market aware and accommodate the fact that a great deal of pharmaceutical business in South Korea is focused on generic products. “Only a few new chemical entities (NCEs) have been developed in this geography,” he said.

“Our message to the attendees here was one of value engineering, overall equipment effectiveness (OEE) and the clear benefits that can be achieved with continuous granulation and continuous direct compression in terms of yield, process optimisation and cost savings.”

Case in point

“The GEA ConsiGma 1 in combination with the ConsiGma 25, for example, combines Quality by Design (QbD) principles with automated Design of Experiment (DoE) to explore and optimise a wide range of process parameters with less product in a shorter timeframe, resulting in a better understanding of continuous manufacturing and shorter times to market. Arguments that are also valid and important for the lifecycle management of generics.”

“We need to get the message and product right for this market, said Holman, “and the Workium provides an ideal opportunity to do that. Peer-to-peer communication is vital in South Korea because there aren’t as many conferences or trade shows to attend compared with other economies.”

The Sungkyunkwan University (SKKU)

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Sungkyunkwan University is a leading private university in South Korea. The SKKU is located in Seoul and Suwon. Suwon is 45 km away from Seoul and has developed in recent years as one of the Korean industrial centres. The natural sciences campus located there forms the bridge between research and industry.

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