Propanc Biopharma Sets December 2026 GMP Start for PRP Phase 1b Trial
PPCB•Propanc Biopharma’s CEO toured a European CDMO’s 4,500 sqm GMP facility to finalize timelines for preproduction (August 2026), engineering run (October 2026) and GMP manufacture (starting December 2026) of PRP for a Phase 1b FIH study in 30–40 advanced cancer patients. Four-week post-run stability data will support 2026 application in Australia.
1. CEO Tours European CDMO Facility
Propanc’s CEO visited a European CDMO’s two‐site, 4,500 sqm facility—comprising 500 sqm for development, 1,400 sqm for cGMP manufacturing, 400 sqm for analytical testing and a 400 sqm warehouse—to assess equipment and finalize project timelines for PRP production.
2. Production Timeline and Trial Preparation
The joint development team agreed on target dates: preproduction in August 2026, an engineering run in October 2026, and GMP manufacture beginning in December 2026. Four weeks of stability data post-engineering run are expected to support a Phase 1b First-In-Human trial application for 30–40 solid tumor patients in Australia in 2026.
3. Strategic Partnership and CDMO Capabilities
The CDMO holds ISO 9001, ISO 13485, ISO 14001 and GMP certifications and offers end-to-end biologics services, including cell line generation, process development and batch production. This partnership equips Propanc with modern facilities and processes to advance PRP—a fixed combination of trypsinogen and chymotrypsinogen—as a novel metastatic cancer therapy.
