【活动预告】Are you Lyo-ready? The stability and risk management of your samples

Welcome to visit our booth and talk to our expert team next Friday!

17th November 6

2:30 pm – 4:30 pm 

BSC Communal Lab Coworking Area

Unit 701-707, Building 17W,

Hong Kong Science Park

 

ž   Why does Lyophilization require more sophistication than we previously understood?

ž   How confident are you in the stability of your samples?

ž   What patent technologies, QbD, PAT tools are available for quality Lyophilization?

ž   The essential roles of Lyophilizaiton analytical tools.

ž   How does quality lyophilization benefit product values and risk management, with examples?

ž   Based on almost 100 years’ experience and technology in Lyophilization equipment manufacturing (Virtis and Hull) and presented by over 30 years local specialist company.

 

Introduction:

With advanced discovery and technology, samples are getting smaller and smaller and more complex for groundbreaking functions. At the same time, it also increases the instability of the samples in solution form, making lyophilization a more complex process and no longer optional than before. Examples include mRNA-LNP, oligo molecules, IVD molecules, antibodies, ADCs etc. Some novel discovery molecules require 100% lyophilization according to FDA. Sooner or later, scientists and researchers will find that after a series of extensive design and experiments in discovery and development, lyophilization becomes a necessary step before bringing products to market. 

Lyophilization, employed for over a hundred years, is a process to remove water content from a sample through sublimation to prevent sample denaturation. It transforms solution samples into powder form, enhancing product stability, extending shelf life and eliminating the need of cold storage and transportation. Lyophilization was mistakenly considered a simple drying process to remove water content. Due to increasing product complexity, lyophilization now requires real-time control and monitoring for reproducibility. With the cooperation of almost 100 years Lyophilization process and equipment manufacturers and 30 years Hong Kong established local specialist, Tegent and Lyo Innovation Lab can help you assess whether your samples are Lyo-ready using our advanced analysis tools, as an effective risk assessment before proceeding to the next step. We can also ensure you have a nucleated lyophilization process to achieve the best optimized freeze-drying cycles for the best homogeneity, reconstitution rate, reproducibility or scale-up for the future. 

In this talk, our experienced Lyo expert will share our successful stories from various regions and around the globe, demonstrating how our analytical tools, QbD and PAT tools are essentials for a successful Lyophilization in order to have the best stability of your samples without comprising the functionality and hence reduce risk and cost, and how quality lyophilization significantly increases the value of your products.

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