By: IPP Bureau
Last updated : September 02, 2026 9:54 am
With India's medical-devices market projected to reach around US$30 billion by 2030, the exhibition highlighted the growing role of domestic manufacturing alongside global technology partnerships
Clinical-stage biopharmaceutical company Devonian Health Group has completed independent validation and integration of key analytical and biological quality-control technologies for Thykamine, its lead botanical drug candidate targeting fibro-inflammatory diseases.
The development strengthens Devonian's efforts to establish a pharmaceutical-grade manufacturing and quality-control platform for Thykamine as the company advances its clinical programmes and prepares for potential regulatory submissions.
The company's quality-control strategy combines HPLC-MS chemical fingerprinting, Nuclear Magnetic Resonance (NMR) spectroscopy and a cell-based biological potency assay using the U937 human cell line. The biological assay measures macrophage inflammatory protein-1 beta (MIP-1β) as a marker of Thykamine's anti-inflammatory activity.
The HPLC-MS method has been independently validated by Chromak Research Inc., while the U937 cell-based potency assay has been validated by Pacific BioLabs. Both methods have now been incorporated into Devonian's quality assurance and quality-control programme covering Thykamine's extraction, manufacturing and testing.
Importantly, the two independent laboratories are expected to continue conducting chemical characterisation and biological potency testing on future Thykamine production batches. This will provide third-party verification of the product's chemical consistency and biological activity during ongoing manufacturing.
NMR spectroscopy is being used as an additional analytical tool to assess the overall chemical reproducibility of the botanical extract. Devonian said NMR analysis to date has demonstrated more than 98% batch-to-batch reproducibility, supporting the consistency of its proprietary extraction process.
“Manufacturing reproducibility is also about patients. As Thykamine advances through clinical development, we want confidence that the product administered from one manufacturing batch to another is produced according to defined and reproducible chemical and biological quality standards,” said Dr André Boulet, President and CEO, Devonian Health Group.
The company said the multi-layered approach is particularly important for botanical drug development, where products comprise complex mixtures of chemical constituents and therapeutic activity may result from multiple components rather than a single active molecule.
According to Devonian, the US FDA's Botanical Drug Development: Guidance for Industry recognises that chemical characterisation may need to be complemented by biological testing where chemical testing alone is insufficient to establish product quality and therapeutic consistency.
Thykamine is a complex pharmaceutical-grade botanical extract being investigated for anti-inflammatory, antioxidant, immunomodulatory and anti-fibrotic properties. Devonian's manufacturing strategy incorporates controlled sourcing of botanical raw materials, standardised extraction, analytical characterisation, biological potency testing and pharmaceutical quality systems.
The company believes the integration of independently validated chemical and biological testing represents a further step towards establishing reproducible manufacturing controls for Thykamine, potentially supporting its continued clinical development and future regulatory and commercialisation efforts.