Technology Transfer of a Cell-Based Influenza Vaccine

VaxThera, in partnership with SK Bioscience, is establishing local fill-and-finish manufacturing capacity for WHO-prequalified cell-based influenza vaccines (SKYCellflu® TIV/QIV) in Colombia to address vaccine supply gaps in Latin America and the Caribbean. The COVID-19 pandemic exposed severe supply chain vulnerabilities and inequitable vaccine access, highlighting the urgent need for regional manufacturing capacity. This technology transfer advances beyond traditional egg-based systems, as called for by PAHO, leveraging SK Bioscience's WHO-prequalified vaccine (2019) and manufacturing expertise. The project will transfer drug product technology to VaxThera's GMP-certified facility, including workforce training, execution of three Process Performance Qualification batches, QC testing, and stability studies. Data will be submitted to Colombia's INVIMA to enable commercial production. The project strengthens pandemic preparedness and establishes a foundation for potential future drug substance technology transfer to enhance regional self-sufficiency.