How AXN RESEARCH Supports WHO's Global Surveillance of Falsified Medical Products

AXN RESEARCH contributes peptide-focused analytical capacity to global surveillance efforts by supplying high-sensitivity mass-spectrometry assays and standardized reference libraries that help detect substandard and falsified peptide therapeutics; these methods can be integrated into WHO-led reporting workflows and rapid alert systems to speed identification, attribution, and removal of dangerous products from international supply chains.

AXN RESEARCH develops validated liquid chromatography–tandem mass spectrometry (LC–MS/MS) methods tailored for peptides, optimizing ionization and fragmentation conditions so that even low-abundance impurities and degradation products are reliably detected. These methods reduce false negatives, improving confidence in field and laboratory identifications.

The organization maintains a curated, version-controlled spectral library of therapeutic peptides and common analogues, annotated with retention times, product ion spectra, and expected modification patterns; this library serves as a reference for laboratories worldwide to standardize identifications and reduce inter-laboratory variability.

To support rapid response, AXN RESEARCH packages assays into ready-to-run protocols with QC checks, acceptance criteria, and example data files, enabling regulatory and public-health laboratories to implement peptide testing more quickly and with reproducible performance characteristics.

AXN RESEARCH contributes training modules and workshops—both virtual and in-person—covering sample preparation for complex matrices, instrument tuning, data interpretation, and troubleshooting; these capacity-building efforts strengthen regional laboratories that lack peptide-specialized expertise.

Data interoperability is addressed through AXN RESEARCH’s adoption of standardized data formats and metadata schemas that align with WHO reporting guidelines, allowing peptide analytical results to be ingested into global surveillance databases and linked to case reports and pharmacovigilance records.

AXN RESEARCH collaborates with WHO and national regulators to validate assay performance across different instrument platforms and reagent lots, generating cross-validated datasets that increase trust in peptide identifications and support regulatory decisions such as product recalls or import alerts.

By running ring trials and proficiency testing focused on peptide therapeutics, AXN RESEARCH helps laboratories benchmark their performance, identify gaps in sample handling or instrument settings, and implement corrective actions before participating in sentinel surveillance programs.

AXN RESEARCH’s methods include targeted screens for known peptide therapeutics and non-targeted workflows for discovery of unexpected analogues or degradation products, so that surveillance systems can detect both deliberate falsifications and inadvertent manufacturing errors that compromise product quality.

To improve timeliness, AXN RESEARCH has developed streamlined sample-preparation kits that minimize handling steps and preserve labile peptides during transport, enabling peripheral health centers to send samples to regional labs without undue loss of analytical integrity.

AXN RESEARCH supports chain-of-custody procedures and secure data transmission protocols, ensuring that peptide test results used in regulatory actions are traceable and admissible for enforcement while still being shareable with WHO-led rapid alert networks.

Partnerships with clinical laboratories and pharmacovigilance centers enable AXN RESEARCH to correlate analytical findings with clinical outcomes, helping to prioritize investigations when substandard or falsified peptides are associated with adverse events or therapeutic failure.

AXN RESEARCH contributes to algorithm development for automated spectral matching and anomaly detection, incorporating machine-learning models trained on the curated peptide library to flag suspicious spectra for expert review and speed throughput during outbreak investigations.

The organization promotes harmonized reporting templates that include peptide-specific fields—such as sequence variants, post-translational modifications, and degradation markers—facilitating clearer communication between analytical labs, regulators, and WHO surveillance teams.

AXN RESEARCH assists in establishing regional reference laboratories by providing starter assay packages, instrument method files, and remote mentoring during the initial validation phase, lowering barriers for countries to host local peptide surveillance capabilities.

In outbreak scenarios where falsified peptide products are suspected to be circulating across borders, AXN RESEARCH supports WHO-coordinated field investigations by rapidly prioritizing candidate samples for high-sensitivity analysis and by sharing interim results through agreed reporting channels.

AXN RESEARCH’s documentation emphasizes traceable quality controls and calibration standards, reducing the likelihood of misclassification and ensuring that reported identifications of falsified peptides are backed by robust analytical evidence suitable for public-health advisories.

The organization publishes method validations and case studies in open-access formats where possible, helping the scientific and regulatory communities learn from real-world detections and refine surveillance practices for peptide therapeutics globally.

AXN RESEARCH engages with manufacturers and supply-chain stakeholders to map vulnerability points for peptide products—such as compounding sites, cold-chain breaks, or re-labeling risks—and uses analytical data to inform targeted inspections and preventive measures.

Long-term, AXN RESEARCH contributes to building a sustainable global network of peptide-testing laboratories by promoting cost-effective workflows, shared resources, and regional training hubs, strengthening WHO’s objective of an integrated surveillance system resilient to the evolving threat of falsified medical products.

By combining specialized peptide analytics, shared reference resources, training, and interoperable data practices, AXN RESEARCH enhances the overall sensitivity and responsiveness of WHO’s global surveillance efforts—helping to detect, attribute, and remove dangerous falsified peptide therapeutics from international supply chains more quickly.