HLB BioStep and BASSGENBIO to Develop Next-Generation Non-Clinical Service

HLB BioStep has begun building a next-generation non-clinical evaluation solution in collaboration with BASSGENBIO.

On May 20, HLB BioStep announced that it had signed a business agreement with BASSGENBIO to jointly develop an integrated next-generation service that combines artificial intelligence (AI)-based computer simulation analysis (in silico) with non-clinical validation tests based on New Approach Methodologies (NAMs) that serve as animal testing alternatives.

New Approach Methodologies (NAMs) refer to innovative evaluation techniques that can complement or partially replace traditional animal testing, such as organoids, 3D cell models, microphysiological systems, cell-based assays, and in silico analysis.

This agreement is aimed at responding to changes in the global non-clinical evaluation landscape. The strategy is to drive innovation in the non-clinical paradigm by integrating AI prediction technologies and human-relevant evaluation technologies into the existing animal testing-based evaluation system.

BASSGENBIO will provide its AI analysis capabilities to predict efficacy and toxicity in advance based on drug targets and molecular structures. HLB BioStep will then validate these predictions using advanced evaluation technologies such as organoids and organ-on-a-chip (MPS). The two companies plan to establish a unique integrated solution that seamlessly combines digital prediction and actual validation, covering the entire non-clinical development cycle.

The companies will launch a proof-of-concept (PoC) to verify the market acceptability and technical connectivity of the integrated service. During this period, in silico analysis services will be provided free of charge. Both companies plan to refine the integrated service model by validating the consistency between prediction results and experimental outcomes.

Baek Seongjin, CEO of HLB BioStep, stated, "This collaboration is significant in that it connects AI prediction and non-clinical validation tests into a single decision-making process, enabling more sophisticated support for our clients' early-stage drug development decisions." Kim Ho, CEO of BASSGENBIO, commented, "Through data-driven preliminary prediction and precise subsequent validation, we aim to maximize the value of candidate substances at an early stage and suggest efficient development directions."

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