The newly opened lab looks to optimize the interface between upstream and downstream processing, says Slovenian bioprocessing firm BIA Separations.
Developed on the back of customer demand, the upstream processing laboratory aims to optimize the critical interface between upstream and downstream processing for the production of complex molecules and biologics.
BIA Separation CEO Aleš Štrancar said that product-contaminant complexes formed during upstream production represent a consistent and challenging obstacle for downstream processing.
“These complexes interfere with every aspect of bioprocessing and they depress final product quality. Resolving the problem before the first chromatography step dramatically increases purification performance and ensures the lowest possible levels of host-derived DNA in the final product,” he told BioProcess Insider.
BIA Separation’s site is located in Ajdovscina, Slovenia. Image: iStock/naruedom
“Activities in the lab will evaluate the evolution of product-contaminant complexation over the course of upstream production and seek to identify the optimal harvest point. In parallel we will evaluate various treatments and additives to selectively remove complexes in conjunction with harvest.
The lab represents a €500,000 ($583,000) investment and has created five new roles at BIA Separation’s site in Ajdovscina, Slovenia, Štrancar continued. It will also service three to five customer projects at any one time.
Future expansions
The opening coincides with the firm’s 20th anniversary.
“We are delighted to mark it with the opening of this new USP facility,” Štrancar said. “Alongside our many years’ experience and expertise in understanding and controlling bioprocesses, we now have the capability to manage the interface between upstream and downstream processes, which is key for complex biologics production.”
Looking further forward, the firm intends to expand further to meet rapidly growing customer demand for BIA’s CIM (Convective Interaction Media) monolithic chromatographic columns.
Monoliths are used particularly for purification and analytics of large biomolecules like virus particles and exosomes. “We need to increase our manufacturing output at least 30-fold over the next 5 years to keep up with the evolution of our customers’ products from clinical trials to manufacturing,” Štrancar told us.
Earlier this year, BIA Separations teamed up with cell banking firm Nuvonis Technologies to help vaccine and cell therapy developers take on the transition from upstream to downstream.
And the Slovenian company is also collaborating with CMO Biomay to develop an economical production system for double-digit gram-scale production and purification of plasmids larger than 20,000 base pairs (20 kbp).