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:

Formulation development
Lyo-cycle process development and optimization
Manufacturing process development
Mixing and pump-shearing studies
Holding time studies
Freeze-thaw studies
Cleaning validation
Product contact part compatibility studies
Sterilization cycle development and validation
Scalability studies

Need help optimizing your process design? »

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:

Process validation is in accordance with regulatory and cGMP guidelines
Project remains on track and product supply is preserved
Seamless execution for right-the-first-time delivery
Access to a robust system to manage the product lifecycle
Insight to all stage gates required for each phase
Access to stability studies, analytical data, release testing, and other regulatory documentation

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: