#Japan #Tokyo #AI Komei #HyperJ #LegalTech Group

Revolutionizing Regenerative Medicine with HyperJ × AI Komei on IDX

LegalTech Group, based in Tokyo, is pioneering advancements in the field of regenerative medicine and biopharmaceuticals through its latest offering. The new integrated platform named HyperJ × AI Komei on IDX facilitates the authenticity certification and knowledge management of products designed for clinical trials and international export. This innovative solution addresses growing demands in both domestic and foreign litigation support services and encompasses a variety of next-generation brand strategy services.

Background: The Necessity of Product Certification in Clinical Trials and Exports

The need to verify the authenticity of products, particularly in fields such as cell therapies and gene pharmaceuticals, is becoming increasingly emphasized. Regulatory requirements now mandate that manufacturing batches present safety records, histories, and manufacturing processes to third parties. Key concerns that arise in this context include:

• - Are the products from recognized and certified batches?
• - Is there evidence of manufacturing conditions or issues?
• - Can records be generated promptly in English with a chronological structure?

Solution: Visualizing Product Certification and Knowledge with HyperJ × AI Komei

The HyperJ component of this platform offers an array of features, including:

• - Documentation of cell-derived information, manufacturing line processes, inspection results, and sterilization/transport history using blockchain technology, enabling proof of authenticity through QR codes and NFTs on a lot-by-lot basis.
• - Immediate access for clinical trial sites, hospitals, and authorities via smartphones for verification purposes.

Additionally, the AI Komei on IDX segment structures and saves vital manufacturing process documentation, including:

• - Standard Operating Procedures (SOPs), abnormal incidents, corrective actions, and validation documentation.

This allows for the quick retrieval of knowledge to answer inquiries about lot production conditions and action taken pre-emptively by the AI.

Implementation Examples

One successful application of the HyperJ platform includes:

• - A cell product company shipping to international clinical trial sites, verifying the origin, process, and inspection records of each lot through QR codes.
• - Physicians at the trial sites using mobile devices to scan and instantaneously confirm product authenticity and safety.
• - Inquiries from regulatory bodies regarding manufacturing anomalies being promptly addressed with recorded details and corrective actions presented in English by AI Komei.

Benefits of Implementation

The HyperJ × AI Komei platform provides a comprehensive support system for:

• - Authenticity certification, quality assurance, and response to inspections during clinical trials and exports.
• - Streamlined communication and trust-building between global hubs, regulatory authorities, and Contract Research Organizations (CROs).
• - Enhanced efficiency of record-keeping and document submission processes through real-time capabilities and multilingual support.
• - Assurance of product reliability and transparency in the international scope of regenerative medicine.

Future Developments

Upcoming expansions may include:

• - Collaborations with Tokkyo.AI to support international patent strategies for products, processes, and algorithms destined for export.
• - Establishing a foundation for real-time correlation analysis between manufacturing knowledge and therapeutic effectiveness in collaboration with medical institutions.
• - Developing a data-driven management framework for therapeutic products aligned with digital trial support and ESG compliance.

As the legal landscape evolves in the context of health and regenerative technologies, HyperJ × AI Komei on IDX symbolizes a new frontier in trust, proof, and records management, connecting treatment practices to global advancements.

About LegalTech Group

Established in June 2012, LegalTech Group operates within Tokyo and is a subsidiary of the well-respected AOS Technologies. With a strong focus on delivering digital transformation through innovative AI services, they are committed to supporting advancements in LegalTech as a Service (LaaS).
For detailed information about LegalTech Group and inquiries, visit their website at AOS.

For further insights about HyperJ and AI Komei on IDX, check the links here: HyperJ | AI Komei.