Perth Australia, August 19, 2026 -
BioCina is pleased to announce a new partnership with Entropy Neurodynamics Limited (ASX: ENP), a clinical-stage biotechnology company developing precision-controlled psychedelic therapies. Under a newly executed Development and Manufacturing Services Agreement, BioCina has been appointed to GMP manufacture TRP-8803, Entropy's proprietary IV-infused psilocin formulation.
TRP-8803 is designed to address key limitations of oral psilocybin, aiming to provide consistent therapeutic exposure and precise control over the onset, intensity and duration of the psychedelic experience, supporting a reproducible treatment profile suitable for large-scale clinical deployment. Entropy is currently advancing TRP-8803 through an expanding clinical program, including a recently approved 72-patient study across eight neuropsychiatric indications of high unmet clinical need.
Under the agreement, BioCina will undertake a comprehensive manufacturing program encompassing analytical verification, engineering batch manufacture, and GMP placebo and active drug product batches. TRP-8803 will be manufactured at BioCina's Perth facility using its Cytiva SA25 robotic aseptic filling line, with product filled into sterile 10 mL glass vials. The manufacturing program is expected to take 24 weeks, with real-time stability studies continuing for 24 months.
The pharmaceutical and stability data generated through this program will form a core component of Entropy's regulatory submissions in the United States, Europe and other major markets, supporting late-stage clinical development of TRP-8803. Establishing this manufacturing capability is a critical part of Entropy's broader Phase 2/3 trial and commercialisation strategy.
Commenting on the partnership, BioCina CEO Dr Thomas Broudy said "We are pleased to partner with Entropy Neurodynamics on the TRP-8803 program. BioCina has significant experience supporting innovative pharmaceutical products through clinical development and commercialisation, backed by established sterile manufacturing infrastructure and global supply capabilities. We look forward to working with Entropy to establish a scalable manufacturing process capable of supporting the continued development of TRP-8803."
Entropy Neurodynamics CEO Mr Jason Carroll said "Our agreement with BioCina is an important strategic step in building the infrastructure required to realise the broader potential of TRP-8803. We are generating an expanding body of clinical evidence around our precision-controlled IV approach to psychedelic therapy and, as that program develops, it is important that we build the pharmaceutical manufacturing capability alongside it. As our multi-indication development strategy advances, this agreement with BioCina ensures that as our clinical evidence base expands, TRP-8803 is supported by a manufacturing engine capable of rapid scale-up, global distribution and commercial-grade consistency. With scalable GMP manufacturing now secured, Entropy is positioned to advance TRP-8803 as a globally relevant therapeutic platform across multiple indications, multiple geographies and with multiple regulatory pathways."
For full details on the TRP-8803 program, including Entropy's clinical trial progress and regulatory strategy, read the ASX announcement here.
About BioCina
BioCina is a global end-to-end Contract Development and Manufacturing Organisation (CDMO) with over 50 years of sterile Drug Product manufacturing experience, serving clients across the U.S., Europe, and Asia Pacific. With facilities recognised by the US FDA, EMA, TGA, and other key regulatory authorities, BioCina delivers Drug Substance and Drug Product solutions from early development through to commercial scale.
BioCina's capabilities span sterile injectable manufacturing of small and large molecule products in multiple formats, as well as microbial biologics, pDNA, mRNA and LNP-based modalities. Partnering with BioCina in Australia provides clients with access to one of the world's most attractive R&D tax incentive programs, offering a meaningful cost advantage throughout development and manufacture.
