How to build an optimal and process design for your steriles drug product.

To achieve high quality results and sustainability within your product’s lifecycle, building out a robust process with agility and flexibility will set you up for long term success as you scale. Our industry experts have the experience to develop an optimal process that is tailored to your unique challenges and needs, which will include:

Short-term strategic investment for long term cost savings

Whether it’s for scaling-up or moving to another facility, technology transfers are part of the normal course of business. In 2019, we successfully completed 119 technology transfers—44 commercial, 60 drug substance, and 15 development.

Our dedicated global experts ensure:

From 2010-2019—within small and large molecule—we have manufactured over 109 products that have received NDA approval. In the past 10 years, we have received as many NDA approvals as the next four CDMOs combined, and more than third of our commercial manufacturing product launches originate from our formulation and development programs.

Ensuring regulatory and cGMP adherence with process validation

We also offer complete process validation in accordance with regulatory and cGMP guidelines—an essential step in the establishment of a reliable high-quality commercial supply. This includes:

Learn more about steriles early development and commercial manufacturing services.

Related Sites

Additional Resources