From the start of our partnership, we focus on laying a foundation for your product’s future success. Take a closer look at how we develop efficient, reproducible and scalable manufacturing processes that are fully optimized for your compound characteristics, target patients, and life cycle strategy.
Your target product profil is our touchstone at every step. Our initial design approach is based on a combination of non-GMP development studies for processability, holistic risk assessment and non-GMP analytics for physical and chemical characteristics.
The data generated by these steps inform our proposed operating ranges, and also help our team identify any critical process parameters that must be controlled to meet your product’s critical quality attributes (CQAs).
After our initial process design workflows, we then perform technical and machinability batches that help us zero in on the most suitable and effective processes for your injectable product.
These early engineering runs factor in all core process steps and are thoroughly monitored throughout their execution. They generate valuable data of process abilities and process robustness that we then incorporate into our evolving, holistic development of your production process.
The knowledge and data we gain during process design, scale-at and scale-up activities provide valuable guidance. Throughout product development, we always keep a close eye on our goal: a validated manufacturing process that delivers robust performance and consistent quality for your product.
As we get closer to the first commercial batch filling, we stay focused on carefully supervising every process performance qualification (PPQ) batch, assessing all batch records against pre-defined acceptance criteria, and carefully coordinating change controls.
Technology transfers are a recurring hurdle for injectable drug products. They’ll take place at numerous points in your product’s life cycle, both between you and your CDMO and within your CDMO’s facilities.
At Vetter, we have the experience and processes needed to streamline and de-risk your transfers. Our fully integrated sites and teams allow optimized transition of drug products and their specific processes, between and within our development and production environments.
Filling your clinical trial material is an essential step for us as we prepare your specific processes. These early aseptic filling run provide crucial insights for further batches and helps us identify and define product-specific handling your molecule may need.
Our technical and analytic experts are here to provide critical insights and guidance at key points in the development cycle and during complex technology transfers. From lab to market, we design your processes to evolve with your product needs and program goals.
