Early-phase decisions can determine whether a sterile program scales successfully or incurs costly delays. As clinical programs advance, choices regarding formulation, process development and analytical strategies can create unexpected challenges if not made with commercial readiness in mind. This playbook takes a deep dive into how sponsors can build a more future-focused sterile development roadmap by addressing critical considerations early and partnering across development functions. The playbook explores: How formulation choices, including solubility, concentration and packaging decisions, can impact manufacturability Why process decisions around batch sizes, hold times and validation strategies influence scale-up success How phase-appropriate analytical approaches and data management support smoother tech transfer and commercialization
