Without lyophilization, nearly 60% of biopharmaceuticals including plasma, vaccines and antibodies could not be commercially available. With a greater trend to outsource manufacturing and more biologicals requiring freeze-drying, this $1.5bn market is set to maintain its year-on-year double digit growth.
Although the commonest way to ensure longevity and stability for complex molecules, lyophilization remains costly, complex and facility-intensive. Fine-tuning cycle parameters and trial-and-error experimentation, also means the procedure remains as much of an art as a science. As reducing development time becomes increasingly important in today s economic climate, a rational, empirical approach to cycle design can save you time and money, especially when upscaling. More importantly, a robust lyophilization cycle will guarantee a safe and effective product.
Mastering these complex and inter-related requirements is no mean feat and Visiongain s 3rd Annual Lyophilization conference provides distilled intelligence on formulation and process development for biopharmaceuticals. With a workshop and sessions led by experts, you will gain a thorough understanding to provide the best outcome for your business. Case studies from industry will offer strategic insights to help you optimize key input and output parameters, and troubleshoot challenges with temperature-sensitive molecules or solid proteins. In addition you will also gain the latest insights into:
- Rational approaches to pre-formulation and formulation process
- Designing product-specific freezing and sublimation and desorption protocols
- Improving analytical methodology to characterize frozen systems and freeze-dried solids
- Characterizing the final dried formulation
- Accurately predicting product stability at the intended storage temperature
- Ensuring cGMP, QbD, QC and QA
- Consistently achieving the desired product quality
- Improving process engineering dynamics and scale up
- Troubleshooting manufacturing problems
- PAT in manufacturing and the lab
