Late last month, LEWA Process Technologies shipped a pilot-scale twin column low pressure chromatography system to Fraunhofer Institute for Interfacial Engineering and Biotechnology in Stuttgart, Germany.
The ‘EcoPrime Twin LPLC’ platform offers continuous loading, elution and regeneration based on proprietary control technology licensed by LEWA from ChromaCon, and has been described by the firm as key to future biologics programmes incorporating continuous processing.
“The hottest trend in biopharma industry for continuous production technology – even more so than single use which is becoming less a trend a more a standard process technology,” chief marketing officer Gerard Gach at the Massachusetts-based firm told us.
Contract manufacturing organisations (CMOs) are particularly interested in shifting away from batch production as a way of increasing throughput, he continued.
“Those CMO’s who have sold out capacity can realise another 20 or 30% more productivity gain resulting in more production capacity within the same footprint.”
The trend is also being driven by payors keen to see the knock-on effect of reduced production expenses to help control the cost of healthcare, and indeed regulators.
“The US FDA has endorsed the implementation of continuous processing promising to work proactively with industry to investigate and implement continuous processing. The FDA sees continuous processing to reduce risk and increase safety / quality as well as make drugs more accessible (lower cost) than present day batch processes.”
LEWA has seen increased demand for its downstream continuous systems in the US and EU, but Gach said there has been just as much interest in Asia due to there being a high interest in biosimilars and less available bioproduction capacity.
“Asia is not burdened by the history of batch production prevalent in the US or EU, thus making this paradigm shift to continuous production easier.”
EcoPrime Twin LPLC
The EcoPrime Twin LPLC is set up to operate as a fully continuous system and LEWA is looking to work with partners to link the GMP downstream production with the upstream.
“The connection to upstream would be based on the end user’s particular process,” Gach said. “No GMP manufacturer has yet achieved process scale continuous downstream - linking all downstream unit operations to form a contiguous, no hold up steps, continuous purification train.
“So linking a continuous upstream to a continuous downstream is yet another step away from realising a full continuous bioprocess production.”
However, the firm is working with ETH Zurich University on a lab scale model of a connected upstream and downstream process using the ChromaCon technology upon which the EcoPrime Twin is based, and once this is established the firm will look to scaling the model up.