Lyophilization USA Conference 2019

5th Annual Lyophilization USA Conference is organized by SMi Group Ltd and will be held from Oct 23 - 24, 2019 at Sheraton Boston Hotel, Boston, Massachusetts, United States of America.

Who Should Attend:
VPs, Directors, Chiefs, Heads, Principals, Managers and Analysts of:
• Lyophilization/Freeze-drying
• Formulation Scientists
• Principal Scientist
• Process Development/Engineer
• Sterile/Fill-Finish
• Production
• PAT
• CMC
• Chemistry
• Manufacturing
• Quality Assurance/QA

Benefits of Attending:
Participating in this year’s SMi Group Lyophilisation USA 2019 conference provides a chance to connect with research and industry leaders with the aim of tackling the most pressing hurdles in multiple areas of interest within lyophilization:
• Gain valuable insight into the most current challenges and considerations when working with highly concentrated and sensitive formulations
• Explore new and innovative approaches in model-based studies that utilize the power of statistical analysis to improve process development and understanding
• Discuss the future outlook of lyophilization through trends in alternative approaches
• Discover updates on the leading PAT technologies such as controlled nucleation, continuous freeze drying, low-frequency Raman, vacuum-foam drying and more.
• Listen to key opinion leaders and experts from regulatory bodies speak about expectations and the assessment of reliable technologies in the market

Description:
The current list of FDA-approved biopharmaceuticals contains up to 50% of injectables and approximately a third of all parenterals being lyophilized, which suggests it is the optimal way of ensuring stability in products that are unstable in aqueous solution. This instability or degradation can result in suboptimal product performance and even toxicity in worst cases indicating the need for lyophilization despite it’s inherently expensive running costs and time-consuming process. 

Join us this year to explore novel and developing technologies that tackle the most pressing challenges and push innovation in world of lyophilization. Benchmark and network with industry leaders and discuss the most up to date and relevant topics that delve into alternative lyophilization approaches, applied statistical modelling, fresh views on scaling up and tech transfer, pre- and post-product characterization. regulation and beyond.

WorkShop: 1 (Oct 25, 2019)
Current and Future Freeze-drying Technologies and Methods

Description:
Freeze dried products are well established in the market and there is an increasing trend in aseptically produced lyophilized products, including peptides and proteins. The workshop will give an introduction into the Physics and Thermodynamics of Freeze Drying; including both presentation of topics and an open discussion within the group. The session will support a better understanding of the Freeze Drying process with the different methods available in the market, including technical aspects for consideration. The session will also discuss an alternative Freeze Drying process for consideration.

Benefits of Attending:
This workshop is aimed at individuals from various backgrounds within the pharmaceutical, animal health and diagnostic industry including, but not limited to, Process / Site Engineers, Production, Validation Engineers, Project Managers and Cycle Developers (R&D). The workshop will also be of interest to participants working in areas of manufacturing / final fill process and packaging. Participants will have the opportunity to engage in an in-depth discussion with industry experts from Optima on the latest technological developments in the Lyophilization industry. Participants will gain a better understanding of the most up to date freeze-drying technology which is available on the market, as well as what the future of this field looks like. Enhance your knowledge on controlled nucleation, available PAT’s and the future of flexible PAT processes, and alternative freeze dryer technologies including spray drying, spin freeze-drying and microwave drying.

Workshop:2
Lyophilization Process Design for a Given Formulation. Principles of Process Scale Up and Transfer, Introduction to the Design Space

Description:
Workshop will provide insights in the development of lyo-friendly formulations and lyophilization process design using Excel based primary drying model. Attendees will be also introduced to the process of inputs generation for the primary drying model, while accounting for the differences in scale. Primary drying model and formulation design templates will be provided to the attendees with the demonstration of their functionality.

Who Should Attend:
Formulation and process development scientists who are interested in utilizing modelling for the lyophilization process design, scale up and transfer

Time: 9:00 am to 5:00 pm