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Conference Documentation: Lyophilization USA

Conference Documentation: Lyophilization USA

SMi Group’s 2nd Annual Lyophilisation USA conference returns to the USA on April 27-28 in 2016.

The thriving biopharmaceutical industry and rise in contract services are driving lyophilization in an exponential rate. In addition, the rise of combination products and innovative drug delivery devices enable innovative drug formulations which can only be stable in solid format. As a result, the global lyophilization market is estimated to grow from a value of US $2.bn in 2013 to US$4.8 bn by 2020.*

While companies are still dedicating research efforts on drying technologies, commerciality of scaling up and homogeneity of product quality remain top concerns amongst pharmaceutical companies.

The SMi 2nd annual Lyophilization USA conference returns to New Jersey in 2016 to go one step further, exploring and assessing how QbD can accelerate drug development and lyophilization programme, industrialization and scale-up for economic cycle, as well as overcoming regulatory uncertainties.

Join us today to gain practical insights for optimal commercialization of your lyophilization program for a replenished drug pipeline!


Day 1
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
9:10
QbD Principles – How Can This Help with Topical Dosage Formula?
Naveen Kanthamneni, Formulation Scientist, R&D Development, Endo Pharmaceuticals Inc.
9:50
Effect of Pressure and Dryer Load upon Secondary Drying Rates
Jim Searles, Technical Fellow, Global Technical Services, Pfizer
10:30
Morning Coffee
11:00
Load Them Properly: Lessons Learnt from the Condenser Coil Temperature Alarms
Vineet Kumar, Senior Scientist, Johnson And Johnson
12:20
Protein Stability: Change in the Apparent Acidity During Freezing and Drying
Ke Wu, Senior Scientist, Allergan
12:20
Networking Lunch
13:20
ControLyoTM Nucleation on Demand: The Impact of Controlling Nucleation on Finished Material Attributes and Processing Characteristics for Bulk Material and Vialed Product
Dr. Karen Bossert, Vice President, Scientific Affairs, Lyophilization Technology, Inc
14:00
Residual Water Content in a Lyophilized Drug Product – Optimizing Secondary Drying
Lisa Harwick, Research Scientist, Baxter BioPharma Solutions
14:40
Afternoon Tea & Networking Break
15:10
Phase-Appropriate Regulatory Strategies: A Focus on QbD Elements
Lotte McNamara, Principal Consultant, PAREXEL
15:50
Aseptic Spray Drying as an Alternative to Lyophilization?
Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S
16:30
Panel Discussion: Is Lyophilization the Way to Go Forward?
Padam Sharma, Sterile Drug Products, Injectables, External Contract Manufacturing, Aseptic Processing, Allergan Inc
16:30
Panel Discussion: Is Lyophilization the Way to Go Forward?
Salman Muzammil, Drug Product Development, Janssen
17:10
Chairman’s Closing Remarks and Close of Day One
Day 2
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
9:10
Commercial Competitiveness of Lyophilized Products
Mark Yang, Director, Genzyme
9:50
Clearing the Fog: Characterization of the Fogged Layer in Lyophilized Products and Studies with Hydrophobic-Coated Vials
Chris Heynes, Senior Engineer, Genentech
10:30
Morning Coffee
11:00
Validation of Filling Operations
11:00
Accurate and Reliable Determination of Collapse Temperature by Optical Coherence Tomography-Freeze Drying Microscope (OCT-FDM)
Vamsi Mudhivarthi, Postdoctoral Fellow, University Of Connecticut
11:40
Freeze Dried Medical Device Products
Mrinal Shah, Senior Engineer, Process Development, LifeCell Corporation
12:20
Networking Lunch
13:20
Looking at Lyophilization from ICH Q8(R2) Perspective
Ravi S. Harapanhalli, Principal, FDAPharma Consulting
14:00
Freeze Thaw for Protein Stabilization
Jamie Tsung, Principal Scientist, Momenta Pharmaceuticals Inc
14:40
Afternoon Tea & Networking Break
15:10
Comparability Studies for Tech Transfer in Lyophilization
15:50
Looking Beyond – Is Drying the Only Way to Go?
Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S
15:50
Looking Beyond – Is Drying the Only Way to Go?
Padam Sharma, Sterile Drug Products, Injectables, External Contract Manufacturing, Aseptic Processing, Allergan Inc
16:30
Chairman’s Closing Remarks and Close of Day Two

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