Formulation and Lyophilization Cycle Development & Optimization
LSNE has been developing and optimizing formulations and freeze drying cycles for more than two decades — over 600 programs and counting. It’s how we got started, it’s the cornerstone of our business and it’s helped us become a global leader. Simply put, we are the lyophilization experts.
- CQA & experiment plan development
- Excipient screening and formulation development
- Lyophilization feasibility
- Accelerated stability
- Freeze-dry microscopy & differential scanning calorimetry (FDM/mDSC)
- Process development and scale-up to cGMP
- Toxicology batches
- Tech transfer
Our broad experience with freeze drying of drug products, intermediates and medical devices sets LSNE apart. It enables us to create custom development plans using statistical Design of Experiments (DoE) that minimizes the amount of your expensive drug substance/API or raw materials required for development. We can also expedite development time and reduce cycle times, thereby lowering future manufacturing costs.
LSNE utilizes Quality by Design (QbD) to perform multiple experiments in parallel, or accelerate one project in your program by using several of our 8 dedicated lyophilizers in tandem. Our dedicated R&D lyophilizers offer internal and external condensers as well as a sample thief to gather real-time data to support cycle development. We can efficiently transfer commercially robust cycles from small scale development to our large-scale cGMP lyophilizer, and optimize processes that were developed elsewhere to provide a commercially desirable process.
We have the know-how. We have the facilities. We have the people and processes to deliver what you need. We can optimize your formulations and freeze drying cycles, avoid missteps, and make the most of your precious resources and time.