Overview
Biologics represent the fastest-growing segment of modern therapeutics, requiring precise environmental controls, stringent documentation, and uninterrupted supply chain integrity. Aevum Zenth's Biologics Handling division operates a purpose-built network of controlled-temperature facilities, validated transport fleets, and digital tracking systems designed exclusively for biological products.
Our infrastructure supports the full lifecycle of biologic products: from biomanufacturing transfer and bulk storage to clinical distribution, commercial cold chain, and post-market surveillance. Every touchpoint is governed by automated compliance logging, predictive risk modeling, and continuous process validation.
Core Capabilities
Ultra-Cold Storage
Validated storage ranging from 2°C–8°C to -196°C (LN2), with redundant cooling systems and continuous environmental telemetry.
Active Cold Chain Transport
GPS-tracked, actively cooled vehicles and air freight containers with real-time temperature, humidity, and shock monitoring.
Cleanroom & Biosafety
ISO 5–7 classified handling zones for aseptically packaged products, cell & gene therapies, and high-potency biologics.
Automated Material Handling
Robotic storage retrieval, AI-optimized pick/pack workflows, and contactless transfer protocols to minimize human exposure.
Serialization & Track & Trace
GS1-compliant unit-level serialization, blockchain-verified chain of custody, and automated reconciliation for recalls.
Cross-Border Biologics
Pre-cleared customs lanes, bonded cold-storage transit hubs, and regulatory liaison teams for international shipment compliance.
Technology & Infrastructure
Our biologics network is integrated with Aevum Zenth's proprietary logistics operating system, delivering enterprise-grade visibility and predictive control across the supply chain.
Zenth BioChain™ Platform
Unified control layer connecting warehouse management (WMS), transport execution (TMS), IoT sensors, and regulatory documentation. Features include dynamic route optimization for temperature excursions, automated deviation reporting, and AI-driven demand forecasting specific to biologic shelf-life constraints.
Facility Specifications
- Primary Hubs: Neo Geneva, Zurich / Newark, NJ / Frankfurt, DE / Singapore
- Capacity: 1.2M+ pallet positions across validated cold zones
- Power Redundancy: N+1 UPS + Dual diesel generators + Grid interconnect
- Data Integrity: 21 CFR Part 11 compliant electronic records, automated backup, immutable audit trails
Regulatory Compliance
All biologics handling operations are continuously audited against international regulatory frameworks. Our Quality Assurance division maintains direct liaison with regulatory bodies and conducts internal mock inspections quarterly.
| Standard / Regulation | Scope | Status |
|---|---|---|
| EU GDP (Guidelines on Good Distribution Practice) | Storage, Transport, Documentation | Certified |
| FDA 21 CFR Part 211 / 600 | CGMP, Biologics Licensing | Certified |
| ICH Q7 / Q9 / Q10 | Quality Risk Management, QMS | Aligned |
| WHO Technical Report Series No. 961 | Cold Chain Validation | Validated |
| ISO 13485 / 14644 (Cleanroom) | Medical Devices / Controlled Environments | In Progress |
Validation & Quality Assurance
Every new facility, storage zone, and transport modality undergoes rigorous qualification before commercial deployment. Our validation protocol follows the V-Model methodology:
- Design Qualification (DQ): Specification alignment with therapeutic requirements
- Installation Qualification (IQ): Equipment verification and calibration
- Operational Qualification (OQ): System performance under defined parameters
- Performance Qualification (PQ): Sustained validation with dummy loads and worst-case scenario testing
- Continuous Monitoring: Annual re-validation, trend analysis, and preventive maintenance scheduling
All validation reports are stored in our immutable quality database and available for client or regulatory audit upon request. Deviation management follows CAPA (Corrective and Preventive Action) workflows with automated escalation thresholds.
Global Network & Partnerships
Aevum Zenth operates 28 primary biologics hubs and maintains strategic partnerships with 140+ regional distributors to ensure last-mile integrity. Our cross-border logistics team manages customs clearance, import/export licensing, and temperature-controlled handoffs to maintain chain of custody across international shipments.
Key therapeutic specialties include:
- Messenger RNA & Viral Vector Vaccines
- Monoclonal Antibodies & Biosimilars
- Cell & Gene Therapies (AUT & CAR-T)
- Enzyme Replacement Therapies
- Blood Derivatives & Plasma Fractionates
Ready to Secure Your Biologics Supply Chain?
Connect with our Biologics Operations team for capacity planning, regulatory alignment, or integration with the Zenth BioChain™ platform.