Luisa Amoedo | VP Operations Recipharm Advance Bio
Recipharm
Luisa Amoedo Otero is a biotechnology industry executive with over 22 years of experience in GMP/GLP pharmaceutical manufacturing, with a career built around launching and scaling biomanufacturing operations for the global life sciences sector. She currently serves as VP of Operations at Recipharm Advance Bio, overseeing operations, supply chain, engineering, and procurement across manufacturing sites in the United States, Germany, and Portugal. Previously, she led the design, construction, and startup of Viralgen's biotechnology plant in San Sebastián, a facility supporting viral vector and gene therapy production, and served as Lab Operation Head across Sartorius CMTS sites in Ulm, Glasgow, and Cambridge (Boston) — steering operations through the COVID-19 crisis while delivering significant gains in productivity and sales capacity. Earlier in her career, she led the construction and startup of the mAbxience biotechnology plant in León, achieving regulatory approval from the EMA, ANMAT, and health authorities in Mexico, Saudi Arabia, and Turkey, and spent nearly a decade at Lonza Biologics implementing biotechnology manufacturing processes across multiple customer programs and international regulatory audits. A chemist by training (University of Santiago de Compostela) with an MBA and postgraduate training in operational excellence (Lean/Six Sigma), Luisa is recognized for her ability to build multidisciplinary teams and translate complex regulatory and manufacturing requirements into operational results. She was named Best Export and Internationalization Executive (Castilla y León Económica, 2018) and Best Executive/Entrepreneur of the Year (ASELE/FELE, 2022).
Appearances:
Day 2 (21st October) @ 15:00
End to end Vaccines Manufacturing at Recipharm
Vaccine developers succeed when they can focus on the science, not on stitching together a fragmented manufacturing supply chain. In this talk, Luisa Amoedo Otero, VP Operations, Advanced Biologics at Recipharm, draws on more than 22 years of GMP/GLP biomanufacturing and CDMO experience to present Recipharm's end-to-end, "bench to clinic" approach to vaccine manufacturing.
The talk traces the full development pathway within a single CDMO network, from process development through preclinical, clinical (Phase I–III), and commercial-scale production, highlighting how consolidating these stages reduces handoffs and technology transfers to accelerate time-to-clinic and time-to-market. It surveys the technological breadth underpinning this model: cell culture and downstream purification for recombinant protein vaccines; upstream/downstream optimization across mammalian, insect, and microbial systems; and capabilities spanning plasmid DNA, xRNA, lipid nanoparticles, viral vectors, sterile fill and finish (including mRNA vaccines in lyophilised and liquid formats) and AI-enabled process analytical technology aimed at continuous, next-generation manufacturing. Fill and finish as well as delivery format considerations are discussed as decisions integrated early with formulation and stability planning rather than treated as a downstream afterthought.
Central to the talk is Recipharm's collaboration model: transparent, shared visibility into timelines, risk, and quality data across a coordinated network of 17 sites in the EU and US, designed to give partners a consistent experience regardless of location or platform. The talk closes by situating this model within current global pressures (vaccine access in low- and middle-income countries, pandemic preparedness, and the need for speed with emerging platforms like xRNA) arguing that technology-agnostic, end-to-end manufacturing capability is a source of resilience and speed for vaccine developers today.
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