Advisory Across the Full Development Lifecycle
CMC Strategy & De-risking
CMC Strategy & De-risking
CMC Strategy & De-risking
Translating science into scalable, inspection-ready development plans aligned with FDA and EMA expectations.
GMP Organisation Building
CMC Strategy & De-risking
CMC Strategy & De-risking
Designing and implementing quality systems, GMP operations, and cold-chain supply networks from early stage to commercial readiness.
Regulatory & Transaction Readiness
Supporting due diligence, pre-approval inspections, and M&A readiness across advanced therapy and biologics programmes.
Clinical Supply Chain
Structuring and qualifying outsourced clinical supply chains across CDMOs globally — the Americas, Europe, and Asia.
About hemalex.bio
25+ Years Bridging Science and Regulated Manufacturing
Koen Huygens is a biopharmaceutical executive and EU Qualified Person with broad experience across advanced therapies, vaccines, and biologics. Throughout his career he has built GMP organisations, guided programmes through regulatory approval, and supported value-creating transactions.
Based in Belgium and working internationally, Koen provides senior advisory and interim leadership through hemalex.bio to biotech companies and investors across Europe, the Americas, and Asia-Pacific.
Selected Experience
Over two decades of engagement across cell therapy, gene therapy, mRNA, vaccines, and monoclonal antibodies — working with companies at every stage from preclinical through to commercial launch.
Vicebio Ltd (UK) - Chief Quality Officer
Built global clinical supply chain and GxP quality systems from the ground up; Vicebio was acquired by Sanofi vaccines for USD 1.6 billion (2025).
eTheRNA Immunotherapies (BE) - Senior Director Process Development & QP
Built Process Development organisation, implemented mRNA purification and LNP manufacturing capabilities. Secured GMP certification following national health authority inspection.
TiGenix (BE) - Director Operations & QP
Led manufacturing operations for ChondroCelect, Europe's first approved ATMP. Contributed to Euronext IPO and secured GMP licence and pre-approval inspection for commercial manufacturing.
Multiple clients across the Americas, Europe & Asia
Manufacturing troubleshooting, QMS implementation, GMP audits, CMC gap assessments, CDMO selection and qualification across cell therapy, gene therapy, and biologics programmes.