Architectural, Guaranteed Integrity (A.G.I.) for Life-Critical Systems
This repository hosts the complete AMAGI & Althea Ecosystem — a dual-architecture framework for:
- AMAGI: Hardware-enforced AI Safety and Compliance (EU AI Act, IEC 61508, ISO/IEC 15408, NIST AI RMF).
- Althea: Open Bioengineering Architecture for Precision Oncology (CRISPR-TTP).
Author: Alexey Mikhailovich Burlai ORCID: 0009-0001-4679-5967 Contact: lexintrud@gmail.com Legal Entity: AGIAM Technologies Ltd (UK) / LLC "Althea" (Russia)
docs/
├── amagi/
│ ├── specs/ # Architectural Specifications
│ │ ├── Amagi_Framework_v2.0_Specification.pdf
│ │ ├── Amagi_NIPU_v1.1_Specification.pdf
│ │ ├── Amagi_MEM_v1.1_Specification.pdf
│ │ ├── Amagi_Master_Parameter_Sheet_v2.0.pdf
│ │ └── Amagi_Open_Specification_v1.1.pdf
│ │
│ ├── safety-analysis/ # Functional Safety Artifacts
│ │ ├── Amagi_HARA_v1.0.pdf
│ │ ├── Amagi_FMEDA_v1.0.pdf
│ │ └── Amagi_Traceability_Matrix_v1.0.pdf
│ │
│ ├── regulatory/ # Compliance & Regulatory Mapping
│ │ └── AMAGI_NIST_AI_RMF_Profile_v1.1.pdf
│ │
│ └── governance/ # Legal, Licensing & Institutional
│ ├── AGIAM_Charter_v1.2.pdf
│ ├── Amagi-SAPL_v2.0.pdf
│ ├── Amagi_Architectural_Class_Definition_v1.1.pdf
│ └── Amagi_Framework_Trade_Secrets_Notice_v1.0.pdf
│
└── althea/
├── specs/ # Bioengineering Specifications
│ ├── Althea_v4.0_Official_Publication.pdf
│ └── Althea_AMAGI_Strategic_Partnership_Offer_v1.0.pdf
│
└── clinical-protocols/ # Standardized Operating Procedures
└── SOP_Althea_CRISPR-TTP_v2.0.pdf
| # | Invariant | Description |
|---|---|---|
| INV-001 | Single-Core Determinism | No caches, no speculation, fixed-latency instruction stream |
| INV-002 | Hardware-Enforced TTP Triad | CRTM response ≤ 15 µs, EGW gate-close ≤ 50 ns, cryptographic attestation |
| INV-003 | Dual-Tier Trust Model | Tier-1 (Safety Kernel) vs Tier-2 (Application Sandbox), one-way isolation |
| INV-004 | Memory Partitioning | MAG (eFuse/OTP), SHMF (executable), Audit Log (append-only hash-chained) |
| INV-005 | Cryptographic Determinism | ML-KEM-1024, ML-DSA-44, SLH-DSA-128f — post-quantum from first boot |
| INV-006 | Provable Shutdown | Any invariant violation forces CRTM-safe state within one watchdog tick |
- NIPU (Neuro-Immune Processing Unit) — deterministic single-core safety controller with SCC FSM
- MEM (Self-Protecting Memory) — three-tier memory hierarchy (MAG / SHMF / Audit Diode)
- MPS (Master Parameter Sheet) — single source of truth for all quantitative parameters
| Standard | Scope |
|---|---|
| ISO/IEC 15408 (Common Criteria) | EAL4+ Protection Profile |
| IEC 61508 | SIL2 functional safety |
| ISO 26262 | ASIL D automotive safety |
| EU AI Act Annex IV | High-risk AI system documentation |
| NIST AI RMF (AI 100-1) | Target Profile |
| FDA PCCP | Pre-market Certifiable Change Package |
| NIST SP 800-218 | SSDF alignment |
- Target: Fusion-driven cancers (Ewing Sarcoma, EWSR1-FLI1)
- Mechanism: CRISPR-Cas9 edited autologous dendritic cells (>94% efficiency) + FUS-activated HOF nanoparticles
- Delivery: Temporally Programmed Delivery (TTP) via MR-guided Focused Ultrasound
- AI Co-pilot: Real-time personalization (89.3% sgRNA prediction accuracy)
- EMA: ATMP classification determined (Feb 2026)
- FDA CBER: INTERACT meeting confirmed (Feb 2026)
- Russian MoH: Expert evaluation completed (Feb 2026)
- Peer-reviewed: Frontiers in Genetics, 2026
| Document | Version | DOI | File |
|---|---|---|---|
| Framework | v2.0 | 10.5281/zenodo.20753400 | docs/amagi/specs/ |
| NIPU (Processor) | v1.1 | 10.5281/zenodo.20753401 | docs/amagi/specs/ |
| MEM (Memory) | v1.1 | 10.5281/zenodo.20753402 | docs/amagi/specs/ |
| Master Parameter Sheet | v2.0 | 10.5281/zenodo.20145212 | docs/amagi/specs/ |
| Open Specification | v1.1 | 10.5281/zenodo.20753403 | docs/amagi/specs/ |
| HARA | v1.0 | 10.5281/zenodo.20753408 | docs/amagi/safety-analysis/ |
| FMEDA | v1.0 | 10.5281/zenodo.20753410 | docs/amagi/safety-analysis/ |
| Traceability Matrix | v1.0 | 10.5281/zenodo.20753412 | docs/amagi/safety-analysis/ |
| NIST AI RMF Profile | v1.1 | 10.5281/zenodo.20753404 | docs/amagi/regulatory/ |
| S-APL License | v2.0 | 10.5281/zenodo.20753406 | docs/amagi/governance/ |
| AGIAM Charter | v1.2 | 10.5281/zenodo.20753872 | docs/amagi/governance/ |
| Architectural Class Definition | v1.1 | 10.5281/zenodo.20145198 | docs/amagi/governance/ |
| Trade Secrets Notice | v1.0 | 10.5281/zenodo.17886699 | docs/amagi/governance/ |
| Document | Version | DOI / Link | File |
|---|---|---|---|
| Official Publication | v4.0 | 10.3389/fgene.2026.1727708 | docs/althea/specs/ |
| Genomic Innovation Spec | v4.0 | 10.5281/zenodo.17780623 | Zenodo |
| Clinical Protocol (SOP) | v2.0 | 10.5281/zenodo.17676423 | docs/althea/clinical-protocols/ |
| Strategic Partnership | v1.0 | 10.5281/zenodo.18718186 | docs/althea/specs/ |
| TTP Architecture | v3.0 | 10.5281/zenodo.17237907 | Zenodo |
| CRISPR Autovaccination | v3.0 | 10.5281/zenodo.17246573 | Zenodo |
This project operates under a Dual-Layer Licensing Strategy:
- AMAGI Specifications: CC BY-NC 4.0 (Non-Commercial Research).
- Althea Protocols: CC0 1.0 (Public Domain).
- Goal: Establish Prior Art, enable academic research, prevent patent thickets.
- License: Strict Architectural Principle License (S-APL).
- Full text: 10.5281/zenodo.20753406
- Governed by: Laws of England and Wales.
- Covers: Commercial deployment, "Amagi Compliant" certification, access to Hard IP Suite (GDSII, Netlists).
- Contact: lexintrud@gmail.com (Subject: "S-APL Inquiry").
Note: Access to trade secrets (implementation details, calibration data) requires an NDA + valid S-APL license.
We invite collaboration with:
- Semiconductor Companies: For ASIC/FPGA implementation of AMAGI Hard IP.
- Biotech & Pharma: For clinical translation of Althea protocols.
- Regulators & Auditors: For certification pathway development.
- Research Institutions: For joint grants and validation studies.
Next Steps:
- Review the Strategic Partnership Offer.
- Contact us at
lexintrud@gmail.com. - Execute NDA and S-APL License (for commercial projects).
- Founding Charter: AGIAM Charter v1.2
- IP Succession: Shamir 3-of-5 secret sharing (Charter §5)
- Jurisdiction: Laws of England and Wales.
- Dispute Resolution: Binding arbitration in London.
- Ethical Guardrails: Strict prohibition on mass surveillance, autonomous weapons, and social scoring. Violations result in immediate license revocation.
- Medical: The Althea framework is a research protocol. It does not constitute medical advice. Clinical use requires regulatory approval and independent validation.
- Safety: AMAGI specifications are reference architectures. Implementation responsibility lies with the licensee.
- No Warranty: Provided "AS-IS" without warranties of any kind.
© 2025–2026 Alexey M. Burlai. All rights reserved. AMAGI: Trust by Design. Althea: Survival by Architecture.