[Edaily Reporter Na Eun-kyung] As interest grows in next-generation preclinical evaluation technologies that can replace animal testing in the global pharmaceutical industry, the business model of #HLB BioStep, a contract research organization (CRO) specializing in preclinical testing, is also evolving.

As concerns mount that traditional animal-based preclinical evaluations alone are insufficient for accurately predicting drug responses in humans, alternative testing methods (NAMs, or New Approach Methodologies) utilizing organoids, organ-on-a-chip technology, and AI-based predictive technologies are emerging as viable alternatives.

Establishing a Consortium of Organoids, AI, and Organ-on-a-Chip Technologies

According to HLB BioStep on the 6th, the company recently signed a Memorandum of Understanding (MOU) with Radahim, a company specializing in organoids. Radahim possesses technology for the standardization and mass production of organoids, and the two companies are collaborating on the development of organoid-based preclinical evaluation models.

HLB BioStep is currently exploring the feasibility of establishing evaluation models for drug-induced liver injury (DILI) and metabolic dysfunction-associated steatohepatitis (MASH) using liver organoids. Through this, HLB BioStep plans to expand its organoid-based drug efficacy and toxicity evaluation services.

In the organ-on-a-chip sector, the company is collaborating with the Dutch firm Chiron. Chiron possesses evaluation platforms based on organ-on-a-chip and model-based systems (MPS). The two companies are working to establish organ-on-a-chip-based evaluation models for specific disease areas, such as osteoarthritis. HLB BioStep provides its domestic customer network and non-clinical evaluation expertise, while Chiron contributes its organ-on-a-chip technology.

In the AI sector, the company has established a partnership with Basgen Bio. Basgen Bio is developing technology to predict drug responses using an AI platform based on genomic and clinical big data. The two companies are working to build an integrated platform that validates AI-based in silico analysis results using organoid and organ-on-a-chip evaluation technologies.

HLB BioStep is also collaborating with Seratgen. Seratgen is developing a new drug evaluation platform based on organoids and stem cells. Seratgen has secured commercialization rights for organoid models for evaluating liver and lung diseases from iPS Academia Japan. The two companies will expand related evaluation services by combining HLB BioStep’s customer network with Seratgen’s organoid technology.

The backdrop to HLB BioStep’s successive collaborations with organoid, organ-on-a-chip, and AI companies is the changing global non-clinical regulatory landscape. As the recognition grows that animal testing alone cannot sufficiently predict drug responses in humans, both regulatory agencies and the pharmaceutical industry are moving to expand the use of NAMs.

Non-clinical Market: From Alternative Testing Centers to Actual Services

In response to these changes, HLB BioStep is building a hybrid non-clinical platform that combines its existing non-clinical CRO capabilities with NAMs technology. The strategy is to evolve beyond a mere contract research organization conducting animal testing into a decision-support company that more precisely analyzes the success potential and risk factors of candidate compounds in the early stages of new drug development.

The global regulatory environment is rapidly shifting in a direction favorable to the spread of NAMs. The U.S. Food and Drug Administration (FDA) is promoting the reduction of reliance on animal testing and the expansion of evaluation systems utilizing human-derived data. In Europe as well, discussions on the adoption of organoid- and organ-on-a-chip-based evaluation technologies are actively underway.

Animal testing still plays a crucial role in the new drug development process. However, due to physiological differences between animals and humans, there are numerous cases of unexpected failures occurring during the clinical phase. Consequently, organoids that replicate human tissue environments, organ-on-a-chip technologies that mimic biological functions, and AI-based drug prediction technologies are gaining attention as next-generation preclinical evaluation platforms.

HLB BioStep is accelerating the actual commercialization of NAMs technology, centered around its Alternative Testing Center. HLB BioStep is currently building an integrated preclinical service system centered on its Alternative Testing Center, combining organoids, organ-on-a-chip technologies, and AI prediction technologies with its existing capabilities in efficacy, toxicity, and analytical evaluation. Initially, the company plans to prioritize the provision of services with high commercialization potential, such as 3D tumor spheroid evaluation, Caco-2-based drug absorption evaluation, and blood-brain barrier (BBB) permeability evaluation.

The company plans to expand this into an advanced platform that integrates organoids, organ-on-a-chip technologies, and AI-based predictive technologies. The goal is to support new drug development companies in securing a wider range of human-based data prior to entering clinical trials and to enable them to assess the potential and risks of candidate compounds at an early stage.

An HLB BioStep official stated, “We are materializing customer-centric preclinical evaluation services by combining external NAMs technology with our own CRO operational capabilities,” adding, “We will first commercialize 3D cell model-based evaluation services, for which there is high initial demand, and then expand into an advanced evaluation platform that integrates organoids, biomimetic systems, and AI predictive technology.”