Devonian Health Group, a Quebec, Canada-based clinical-stage biopharmaceutical company, has independently validated and integrated analytical and biological quality-control methods into the extraction and manufacturing process for Thykamine, its lead botanical drug candidate.

The quality control strategy combines validated high-performance liquid chromatography-mass spectrometry (HPLC-MS) chemical fingerprinting, nuclear magnetic resonance (NMR) spectroscopy, and a cell-based biological potency assay using the U937 human cell line. The potency assay measures macrophage inflammatory protein-1 beta (MIP-1β) as a biological marker of Thykamine’s anti-inflammatory activity.

U.S.-based Chromak Research independently validated the HPLC-MS method, while Pacific BioLabs independently validated the U937 cell-based potency assay. Devonian has integrated both methods into its quality assurance and quality program governing Thykamine extraction, manufacturing, and quality control.

Chromak Research and Pacific BioLabs are expected to continue performing chemical characterization and potency testing on future production batches, providing independent testing of chemical consistency and biological activity.

Devonian also uses NMR as an orthogonal analytical tool to assess the chemical reproducibility of the botanical extract. According to the company, NMR analyses to date have demonstrated greater than 98% batch-to-batch reproducibility across independently manufactured Thykamine production batches.

The combined analytical strategy provides chemical fingerprinting, structural characterization, and biological potency testing for evaluating batch consistency. Devonian said the approach is intended to support its clinical development programs and potential future regulatory submissions.

Thykamine is a complex, pharmaceutical-grade botanical extract being investigated for anti-inflammatory, antioxidant, immunomodulatory, and anti-fibrotic properties. Devonian’s manufacturing strategy includes controlled sourcing of botanical raw materials, standardized extraction conditions, analytical characterization, biological potency testing, and pharmaceutical quality systems.

The company said the quality control approach addresses the complexity of botanical drug products, which can contain multiple chemical constituents whose biological activity may result from the contribution and interaction of multiple components.