Flexibility Or Scale? Navigating The Single Use Vs. Stainless Steel Debate

Stephanie Wickham, Head of Development at LOTTE Biologics in Syracuse, NY, guides listeners through the critical decision of selecting the right bioreactor platform as drug candidates move toward large‑scale manufacturing. While early development often leans toward agile single‑use systems, stainless‑steel bioreactors remain the gold standard for long‑term commercial success. Stephanie compares both technologies in depth—highlighting single‑use advantages such as faster changeover, reduced contamination risk, lower utility usage, and customizable configurations, along with challenges like extractables and leachables, waste generation, and higher consumable costs. She then contrasts these with stainless‑steel strengths including large‑scale capability, supply‑chain stability, durability, cost efficiency, and reduced product‑contact risk, balanced against slower turnaround and lower flexibility. Ultimately, she emphasizes that the best choice depends on product needs, scale expectations, and the end goal of commercial readiness. The session concludes by spotlighting the Syracuse campus’s proven track record in scaling programs and delivering long‑term manufacturing reliability.