Getting formulation right from the start of early development can help save time and money as you advance through each phase and on to commercialization. Our early development formulation experts and scientists are here to support every step of your project. Gain access to an integrated drug formulation program that is tailored to your large molecule and your process can help you overcome many formulation challenges in the following areas:
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:
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.
Contact us to discuss your project.