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Conference Documentation: Lyophilisation USA

Conference Documentation: Lyophilisation USA

There’s a growing demand for lyophilised pharmaceutical products that are contributing to an increase in the adoption of lyophilisation equipment and the need for lyophilised biopharmaceuticals and other formulations in the pharmaceutical industry. This is contributing to the projected rise in investment, currently dominated by North America, which is expected to reach $4.80 billion in 2020. This rate of growth is a result of new biologics and biosimilars, enhancing the need for lyophilisation equipment and services.

The requirements governed by the FDA and supported by ISPE focus on improving patient safety and product quality – supporting the adoption of lyophilisation in pharmaceutical manufacturing, with the necessity to lyophilise APIs and various formulations such as antibodies, antiviral drugs, insulin, biosimilars, injections and other therapeutic proteins.


Day 1
8:30
Registration & Coffee
9:00
Chairs Opening Remarks
Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH
9:10
Cycle development basic concepts and optimising the process
Ronald Pate, Lyophilization Development Scientist, Patheon Pharmaceuticals Inc.
9:50
Transfer of Lyophilization Processes
Reingard Schandl, Project Manager, Global Technology Transfer, Baxter BioScience
10:30
Advances in Temperature Mapping inside Lyophilizers
Tim Paymaster, President, Ellab Inc
11:10
Morning Coffee
11:40
Improving Lyophilisation Process Efficiency via Primary Drying Optimisation
Swapnil Pansare, Associate Scientist - I, Formulation Sciences, MedImmune Inc
12:20
New Formulation Technologies for Stabilisation of Therapeutic Proteins and Vaccines
Akhilesh Bhambhani, Principal Scientist, Novel Adjuvants, Formulations and Delivery Technologies, Merck & Co. Inc.
13:00
Networking Lunch
14:00
Case Study: Adapting a lyophilization cycle from pirani to capacitance manometer gauge pressure control
James Searles, Technical Fellow, Global Manufacturing Science and Technology, One 2 One Hospira
14:40
Leveraging Sophisticated Modelling in QbD - Why Bother?
Katherine Giacoletti, Senior Statistician, Arlenda
15:20
KEYNOTE ADDRESS: Applying QbD to Freeze-Drying: Space and Time, Risks and Practicalities
Kevin Ward, Director of R&D , BioPharma Technology
16:00
Afternoon Tea
16:30
Drug Product Development Using a QbD approach for Commercialization
Vikram Sadineni, Senior Research Investigator, BMS
17:10
Primary Drying Optimization Using a Three-Dimensional Design Space
Lindsay Wegiel, Research Associate III, Baxter Pharmaceutical Solutions, LLC
17:50
ROUND TABLE DISCUSSION
Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH
18:30
Chairs Closing Remarks and Close of Day One
Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH
Day 2
8:30
Registration & Coffee
9:00
Chairs Opening Remarks
Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH
9:10
KEYNOTE ADDRESS: Hot and cold spot determination to allow for process control by use of Product Temperature Tp PAT Device
Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH
9:50
Freeze Drying PAT using Heat Flux Measurement
T.N. Thompson, President, Millrock Technology, Inc.
10:30
Morning Coffee
11:00
Controlled Nucleation in Production Lyophilizers: Current State of Technology
Paul Coiteux, Director of Technical Sales, SP Scientific
11:40
Spray drying as an alternatvie to freeze drying
Sune Andersen, Drying Processes and Particle Technology in CMC, Novo Nordisk A / S
12:20
Networking Lunch
13:30
INDUSTRY INSIGHT - An example solution : Application of Controlled Ice Nucleation for Lyophilization of a Low Glass Transition Temperature Solution
Graham Magill, Engineer I, Pharmaceutical Processing and Technology Development, Genentech, Inc.
14:10
Case Study: The role of physical chemistry in freeze-drying from product characteristics to process performance
Tudor Arvinte, Professor University of Geneva, Chairman & CEO, Therapeomic Inc., University Of Geneva
14:50
Afternoon Tea
15:20
Concentrated solid dosage formulations of therapeutic biologics
Barry D Moore, CSO, Xstalbio Ltd
16:00
Concentrated dosage formulations effecting biologics and solid therapeutics
Jamie Tsung, Principal Scientist, Momenta Pharmaceuticals Inc
16:40
Chairs Closing Remarks and Close of Day Two
Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH

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