Late phase API development and manufacturing at Sterling

16th Mar 2022

The transition between clinical trials and full commercial approval is an exciting one, with only 12% of products that enter the process ultimately reaching patients. But commercial approval is not the end. In fact, late stage manufacture is marked by several challenges of its own, including uncertain demand, cost pressure, and stringent regulatory demands.

Preparing for commercialisation is when many decisions you made earlier in the lifecycle can come back to haunt you and the scientific and engineering expertise of your outsourced partner can make or break profitability and adoption.

It’s time for your molecule to fulfill its intended mission. How can you best position it for commercial success?

The key is choosing a partner that understands the obstacles associated with late stage and commercial pharmaceutical manufacturing and can help you systematically address them at scale. Like the detailed process of preparing a new drug application, which can be accelerated and streamlined by a partner with deep CMC and analytical expertise.

Or moving your syntheses from the lab to the plant scale, a process that must be carefully managed by a partner that understands the many implications for safety, product quality, and cost. And product quality control, a vital function which can be supported by a partner that prioritises safety, purity, and efficacy even as product quantity increases.

Or environmental sustainability, which requires proactive waste mitigation and careful management for a full range of pharmaceutical waste products. And don’t forget continual process improvement, which demands an innovative partner that continually seeks opportunities for greater efficiency and economies of scale while maintaining critical flexibility.

Preparing for commercial sale of a pharmaceutical product is no small feat, but the right partner can elevate your manufacturing processes through technical excellence, transparency and true scientific collaboration.

At Sterling, we are more than an outsourced vendor for API manufacturing. We are a PDMO®, or partnership development and manufacturing organisation. That means we share in your mission to put your molecule in the hands of patients and are committed to helping you to successfully scale.

Whether this is your first molecule reaching approval or you’ve commercialised dozens of molecules before, you can rely on our world-class facilities, robust equipment, deep technical expertise, cGMP capabilities, expert engineering teams, and much, much more.

Are you ready to overcome growing pains and maximise commercial success with a different kind of outsourced partner?

Sterling. Service. Passion. Science.


Related content


Top 10 late phase considerations