Drug Product Scale-Up & CDMO Tech-Transfer

With a thorough understanding of your product and processes, we help ensure the robustness and quality of your drug product as it scales up through later clinical trials, to registration batches and sustained commercial supply for patients in need. We can help you reduce your risk if you are looking to change CDMO vendors, or add a secondary CDMO supplier.

A strong track record of scaling up drug product from lab and pilot scale to commercial drug product batch sizes. 

As a molecule transitions through development, we're here to support you with deep technical expertise, underpinned by integrated departments and strong project management, as your drug product progresses to multi-kilogram batches.

Maintaining product quality and robustness is essential. Our formulation and process experts support the identification of critical process parameters (CPPs) and critical quality attributes (CQAs), understanding these factors early in drug product formulation development and process development for successful scale-up at later stages.

When your product and processes are being transferred between different organizations and types of equipment, we're here to help streamline your path.

With fully integrated capabilities and common manufacturing processes across our sites, we ensure a quick and seamless approach to technology transfers.

For transfers from an existing provider, or even some products that may require certain equipment or processes, our multidisciplinary project teams will start by gaining a deep understanding of the history of the product. With this foundation, we'll work with you develop and implement your product's development plan.