Spotlight on Key Sessions at SMi’s 3rd Annual Lyophilization USA

As manufacturing demands increase, the global lyophilization market for pharmaceutical and biotechnology products is expected to reach $2.66 billion by 2019, and this a trend that is likely to continue as we push the boundaries of biopharmaceutical formulation and transport.

Featuring an exceptional line-up of keynote speakers from industry leading organisations, SMi’s 3rd Lyophilization USA conference arrives at the perfect time to discuss the latest approaches and strategies in key areas such as holistic packaging and innovative design, formulation during clinical development, the stability of sugar-protein and the impact of controlled nucleation.


– Lyocycle Development and PAT Based Optimization. This case study will analyse the lyo cycle process performance qualification, leading to a PAT real time feedback system controlled lyo cycle for continued process verification. This will involve the critical quality attributes of a freeze-dried product, product temprature, the lyo cycle design space to establish process boundaries.

– Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH

– Hear more from Andrea as she hosts a Half-Day Pre-Conference Workshop on: Implementation of Quality by Design Principles into Lyophilization Processes (Nov 15th).

– Lyophilization Process Development, Scale-up and Technology Transfer Strategies. While selection of excipients is primarily focused on improving product stability, for a freeze-dried product an additional consideration is the compatibility of the formulation with the freeze-drying process. This session will discover the traditional approaches for process design, scale-up, and technology transfer and examine the challenges that can occur when implementing plans for large scale lyophilization.
– Charlie Tang, Director, Formulation Development, Regeneron Pharmaceuticals

– Combined Empirical and Statistical Approach to Screen Lead Excipient Combinations for Lyophilization of Live Attenuated Tetravalent Dengue Vaccine. This talk will focus on a combination experimental approaches utilizing semi-empirical excipient screening. This involves statistical modeling using design of experiments (DOE) and identifying stable candidate formulations for a lyophilized live attenuated Flavivirus vaccine candidate.
– Sushma Kommareddy, Associate Director Formulation Development, Takeda

– Assessing Phase Separation in Lyophilized Protein Formulation. This session will focus on phase separation in lyophilized protein formulations. Specifically, on amorphouse -amorphous phase separation and the pharmaceutical significance. This talk will also describe the process and formulation conditions which promote phase separation and the various methods used for detection. Additionally, case studies will be presented to demonstrate the impact of process parameters and formulation components on phase separation.
– Kelly Forney Stevens, Drug Product Development , GSK

“I enjoyed the conference and would love to come again…a better opportunity for networking”
– Baxter BioPharma Solutions

Further information is available at:

For those looking to attend there is currently a $100 early-bird saving ending this Friday 29th September.

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



Contact Information:

For all media inquiries contact Pavan 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