Avoid rework and costly delays by getting formulation right from the start.
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:
- Small and large molecules—whether it’s a liquid and lyophilized formulation
- Lyophilization cycle optimization
- Temperature and shear-sensitive compounds
- Poorly soluble compounds
- Highly potent compounds
- Container closure system selection
- Product contact part compatibility studies
- Holding time studies
- Freeze-thaw studies
Simplify your process and produce stability within your drug product
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:
- Quality by Design (QbD) and Proven Acceptable Ranges (PAR)
- Validation of analytical assays
- Release testing
- ICH stability studies
- Container shipment studies
- CMC documentation in CTD format
- Continuous Process Validation
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.
