An industry primer urged early integration of packaging strategy across development phases, arguing that container‑closure systems, primary vs. secondary components, and regulatory testing plans must be set before pivotal trials to prevent manufacturing bottlenecks and release delays. The piece synthesizes regulatory best practices and advises emerging biotechs to align packaging with sterility, stability, and administration requirements. On parallel process innovation, a novel accelerated sterility testing method promises results within a single day, a step change from current multi‑day assays. Shorter sterility timelines could compress lot release windows for biologics and cell therapies, contingent on regulatory acceptance and equivalence validation to established sterility assays.