Operational Success By Strategic Investment

By Jason Hartman, VP, Operations

Scaling sterile injectable programs from early development to commercial supply is a complex undertaking shaped by far more than process know-how alone. It requires a deliberate foundation of infrastructure, equipment strategy, and technology that can support reliability, flexibility, and regulatory rigor as products evolve. This article explores how these elements come together to enable consistent performance across the product lifecycle.

At the core is infrastructure designed for predictability — facilities built with resilient systems, real-time monitoring, and the ability to accommodate multiple manufacturing pathways. Strategic equipment selection further reinforces this foundation, ensuring formulations maintain their integrity while transitioning smoothly from small-scale development to commercial production. The thoughtful integration of stainless steel and single-use technologies, paired with in-process analytics, supports both scalability and control.

Equally important is facility flexibility. Modular designs, in-house development capabilities, and cross-functional expertise allow operations to adapt as formulations, processes, or regulatory expectations shift. Layered on top of this foundation are advanced technologies such as automation, digital batch records, real-time analytics, and unified equipment platforms, all of which enhance quality oversight and operational efficiency.

Together, these strategies illustrate how modern sterile injectable manufacturing is built to manage complexity, reduce risk, and maintain momentum as programs move forward.