Achieving Controlled Nucleation During Aseptic Lyophilization

Controlled nucleation is essential for obtaining high-quality lyophilized products with intra-and inter-batch consistency. Two approaches to achieving controlled nucleation have been investigated recently: creating a pressure differential and using an ice fog to insert seed crystals into the vials within the lyophilization chamber.

Morrisa Jones, Senior Scientist, Vaccine Drug Product Development Merck, will be delivering the opening address on day one where she will be comparing and contrasting two methods of controlled nucleation from an industry perspective.

This year’s event will look towards the future of lyophilization. Network with industry experts, discuss regulatory challenges and unmet needs within lyophilization, gain insights into innovative technologies and strategies to overcomechallenges within freeze-drying, discover new methods of scale-up and technology transfer, and explore alternative processes beyond conventional lyophilization.

The two-day event will explore the ever-growing need of informative and thought-provoking discussion, toaddress key industry issues.Lyophilization USA Conference will offer a jam-packed agenda with presentations from key industry leaders and up-and-coming thinkers, within the field.

This year’s expert speaker line-up includes:

  • Alina Alexeenko, Professor, Purdue University
  • Timothy McCoy, Associate Director, Pharmaceutical Development Biologics, Sanofi
  • Rui Fang, Senior Scientist, Merck
  • Sushma Kommareddy, Associate Director, Formulation Development, Takeda
  • Sampreeti Jena, Postdoctoral Associate, University of Minnesota
  • Tom Robinson, Managing Director, Aerosol Therapeutics
  • Fabrice Schlegel, Senior Engineer, Amgen
  • Colin Campbell, Director, Process Development, Elusys Therapeutics
  • Dena Flamm, Business Development Manager, Optima Machinery Corporation
  • Alex Langford, Senior Assoicate Scientist, Pfizer Inc
  • Pouya Tavousi, Postdoctoral Fellow, University of Connecticut
    Plus many more…

Also on the programme – two interactive pre-conference workshops, on November 14:

* Workshop A, morning session – Current and future freeze-drying technologies and methods.
Hosted by Alexander Tambovzev and Dena Flamm of Optima Pharmaand Tom Robinson of Aerosol Therapeutics

* Workshop B, afternoon session – NIPTE: insight into the fundamentals of freeze-drying / lyophilization.
Hosted by Robin Bogner, University of Connecticut


2018 Event Highlights
:

  • Discover novel techniques and advances within lyophilization
  • Gain insight into the regulatory challenges in lyophilization; and how to overcome these challenges
  • Discuss the current unmet needs with lyophilization; and action points needed to address these needs
  • Receive updates onthe most recent analytical and other technologies in lyophilization
  • Hear from the experts on alternative freeze-drying methods beyond vial lyophilization
  • Explore the future of lyophilization through participation in LyoHub

The latest conference brochure is now available to download on the event website, where you can also register online:www.lyophilization-usa.com/pharmanews. Book by Sept 28 and save $100

Interested in sponsoring, exhibiting or speaking at this event?
Contact Alia Malick, Director, on +44 (0)20 7827 6168 or email amalick@smi-online.co.uk

For media enquiries, contact Jinna Sidhu on +44 (0) 20 7827 0688 or hsidhu@smi-online.co.uk

Conference: November 15 – 16, 2018
Workshops: November 14, 2018
Venue: Renaissance Woodbridge Hotel, New Jersey, USA
Website: http://www.lyophilization-usa.com/pharmanews

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