Only 4 Weeks Remain Until SMi’s 3rd Annual Lyophilization USA Conference

Iselin, NJ, October 20, 2017 --( SMi’s Lyopihlization USA will gather leading experts to discuss the latest cutting-edge developments in freeze drying, as well as solutions to on-going industry challenges. A value-packed brochure with top pharma companies joining, including GSK, Tempris, Shire, Takeda Vaccines, Johnson & Johnson and more, who will be presenting a vast range of topics and issues within freeze-drying.

Here is a summary of a few key sessions which cannot be missed:

[Opening Address] Hydrogen Deuterium Exchange Mass Spectrometry for formulation/Process Optimization in Lyophilized Solids

- Basics of hydrogen deuterium exchange Mass Spectrometry (HDX-MS), for formulation and process optimization, will be briefly discussed.
- Impact of formulation parameters, i.e., protein: sucrose ratio, type of stabilizer etc. will be discussed.
- Impact of processing parameters, including controlled ice nucleation and annealing, on stress stability will be discussed.
- Correlation of HDX-MS data with stress stability would be performed to evaluate rank ordering of the impact of processing conditions.
Lokesh Kumar, Associate Scientist, Genentech

Stability of Sugar-Protein Lyophilized Formulations: Evaluation of Phase Separation and Mobility

- Basics of solid-state NMR spectroscopy as a technique for evaluating phase separation and mobility in sugar-protein formulations.
- Impact of sugar crystallization, relaxation times, and phase separation on protein stability will be discussed.
- Comparison of micro-environmental protonation states using solid-state NMR spectroscopy and visible probes will be shown.
Eric Munson, Professor, Pharmaceutical Sciences, University of Kentucky

Holistic Approach to Packaging and Innovative Design

- Case study on innovation in packaging of pharmaceuticals.
- Challenges designing packaging that ensures patient safety and meets regulatory requirements.
- Relating consumer- friendly packaging to lyophilized products.
Guido Schmitz, Head of Packaging & Technology Innovation, Bayer Consumer Care

[Keynote Address] The development and scale up of a freeze drying cycle for biotherapeutics

- Freezing, primary drying and secondary drying design space.
- Scale up and effect of load configuration – secondary drying focus.
- Stability considerations and physical characterization on stability.
- Container closure selection and characterization.
Stuart Wang, Principal Scientist, Shire

Hear from Top Industry Experts:

- Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH
- Charlie Tang, Associate Director, Formulation Development, Regeneron Pharmaceuticals
- Guido Schmitz, Global Head of Packaging & Technology Innovation, Bayer Consumer Care
- Jean- Francois Michiels, Senior Statistician, Arlenda
- Eric Munson, Professor, Pharmaceutical Sciences, University of Kentucky
- Kelly Forney Stevens, Drug Product Development, GSK Vaccines
- Melissa Lash, Scientist, Large Molecule Drug Development, Johnson & Johnson

Why Not Attend The Pre-Conference Workshop?

[Nov. 15th] Implementation of Quality by Design Principles into Lyophilization Processes

Why Attend?

- Learn about quality built into the process in the context of lyo
- Understand the interrelationship of formulation and process
- Learn how to determine the CFT
- What PAT techniques are available?
- Lyocycle robustness testings to evaluate the process boundaries, how to transfer this into commercial scale lyophilization.
Workshop Leader: Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH

These are just some of the unmissable program highlights for 2017. Visit the website to see a full speaker line-up and detailed conference agenda.

For those looking to attend, check out the booking options online.

SMi Presents the 3rd Annual Conference on
Lyophilization USA
Date: November 16th – 17th 2017
Location: Iselin, New Jersey

Sponsored by: Ellab | Schott | Tempris | W.L. Gore & Associates, Inc.

Contact Information:

For all media inquiries contact Pav Solanki on Tel: +44 (0)20 7827 6048 / Email:

About SMi Group:

Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world's most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at
SMi Group
Pav Solanki
+44 (0) 20 7827 6048