It is our mission to provide you with a product that has the highest level of sterility assurance and quality achievable. While we have invested in cutting-edge equipment and in our team, we also focus on our quality system and our approach to solving your complex problems. Our science is guided by the Quality by Design (QbD). This is a systematic approach to development, defined by ICH Q8 guidelines that “begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.”
Before we start, we must define what we need to achieve:
Once we have built our goal posts, we experiment to evaluate potential strategic approaches to achieving our target:
Once we have gathered sufficient evidence, we define a process to achieve QTPP:
Now we have our process developed! After validation, we will continue to monitor and improve the process to assure consistent product quality.
Your product’s Quality Target Product Profile (QTPP) informs us of what we need to achieve. This creates the basis for your drug product formulation and process development. To properly define your QTPP, we will review the following information with you:
For a sterile product, we must also examine:
Download our free guide! This document offers an introductory overview to the fill finish process, which teams are involved, and key differences in filling environments and equipment commonly employed at CDMOs.