What question did this study set out to answer?

The central aim is to present open frameworks for bioengineering and AI safety that invite collaborative efforts.

February 23, 2026Open Access

STRATEGIC PARTNERSHIP OFFER: Open Bioengineering & AI Safety Architectures "Althea" (CRISPR-TTP) + "AMAGI" (Hardware-Enforced AI Safety)

Puntos clave

The central aim is to present open frameworks for bioengineering and AI safety that invite collaborative efforts.
Introduction of the "Althea" bioengineering platform focused on Ewing Sarcoma treatment using CRISPR technology.
Outline of the "AMAGI" AI Safety Architecture focusing on regulatory compliance and safety for AI systems.
Specification of architecture parameters and regulatory readiness based on established frameworks like ISO 26262.
Proposed bioengineering solutions exceed 94% efficiency in genome editing of dendritic cells.
Documentation of regulatory pathways for frameworks being prepared for EMA and FDA evaluations.
Development of hardware components for AI safety enhancing compliance and safety.

Resumen

This document presents an open architecture ecosystem declaration, inviting collaboration on two complementary, fully open frameworks: 1. "Althea" (CRISPR-TTP Bioengineering Platform)A fully open (CC0) bioengineering architecture for the treatment of fusion-driven cancers, with an initial focus on Ewing Sarcoma. The platform integrates: CRISPR-Cas9 genome editing of autologous dendritic cells (>94% efficiency, 17+9 MHC binders); Temporally Programmed Delivery (TTP) via MR-guided Focused Ultrasound (FUS) activating HOF nanoparticles (27 ± 3 nm, 1–2 mm spatial resolution); AI Co-pilot for real-time personalization (89.3% sgRNA prediction accuracy). Regulatory context: EMA: ATMP classification determined within EMA framework (Feb 11, 2026) FDA CBER: INTERACT meeting request submitted and confirmed (Feb 18, 2026) Russian Ministry of Health: Expert evaluation completed (Feb 19, 2026) 2. "AMAGI" (Hardware-Enforced AI Safety Architecture)A reference architecture designed to transform regulatory compliance from a procedural burden into structural guarantees for high-risk AI systems. Core features: Six immutable invariants (Physical Non-Bypassability, Irreducible TCB, Separation of Control, Immutability of Policy, Complete Mediation, Complete Audit Integrity); TTP Triad (Trigger → Programmable Delay → Localized Activation) as a universal safety primitive; Hardware components: SCC (Security Council Core), NIPU (Neuro-Immune Processing Unit), MEM (Self-Protecting Memory), Amagi-Q (post-quantum crypto); Alignment with EU AI Act, NIST AI RMF 1.0, ISO 26262 (ASIL-D) frameworks. Published Works:Both architectures are supported by over 25 peer-reviewed and public-domain documents on Zenodo, all with DOIs. Core principles are publicly disclosed as prior art. What We Offer: Open access to complete architectural specifications (CC0 / CC BY-NC) Regulatory-ready frameworks with documented agency interactions Flexible collaboration formats: research collaboration, licensing (S-APL), IP core integration, grant consortia, and advisory board participation Target Partners:Biotech companies, semiconductor firms, CROs, academic labs, hospitals, and funding organizations interested in co-developing mission-driven, ethically grounded technologies for life-critical applications.

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