TUESDAY, SEPTEMBER 23 WEDNESDAY - lyo

TUESDAY, SEPTEMBER 23
13:00 -17:30
Fundamentals of Pharmaceutical Freeze-Drying - I
A short course in the basics taught by Michael Pikal
and Steve Nail for those new to the subject
WEDNESDAY, SEPTEMBER 24
08:00 -11:00
Fundamentals of Pharmaceutical Freeze-Drying - II
A short course in the basics taught by Michael Pikal
and Steve Nail for those new to the subject
THURSDAY, SEPTEMBER 25
FRIDAY, SEPTEMBER 26
n BIOTECH FORMULATION AND STABILITY
08:30
Lyophilization-Induced Aggregation of a Therapeutic
Peptide
09:00
Interfacial Concentration of Proteins in Lyophilized
Formulations Determines Stability
n PROCESS UNDERSTANDING AND CONTROL
08:30
Mark Manning, Legacy BioDesign, Johnstown, CO, USA
Davide Fissore, Politecnico di Torino, Torino, Italy
09:00
Ted Randolph, University of Colorado, Boulder, CO, USA
09:30
Non-Invasive Monitoring of a Pharmaceutical
Freeze-Drying Process
Freeze-Drying Modelling: Prediction of Spatial
Distribution of Product Quality and Multi-Criteria
Optimization
Stephanie Passot, AgroParisTech, Thiverval-Grignon,
France
Development of Freeze-Dried Products:
Rational Selection of Excipients?
09:30 -12:30
Registration
11:00
WELCOME SNACK LUNCH
10:00
COFFEE BREAK / POSTER / EXHIBITION
12:30
Introduction
10:30
12:45
Keynote Address
Applied Research and Technology Development
Needs in Pharmaceutical Freeze-Drying
Applications of Microwave Vacuum Drying and
Lyospheres to Freeze-Drying of Vaccines and
Biologics
10:00
COFFEE BREAK
Robert Evans, Merck, West Point, PA
10:30
Pressure Variation in the Drying Chamber:
Measurements, Simulations and Consequences
of Scale-up on Batch Uniformity
Mike Pikal, University of Connecticut, Storrs, CT, USA
(on behalf of the Organization Committee)
Evgenyi Shalaev, Allergan, Irvine, CA, USA
11:00
n MATERIALS CHARACTERIZATION
13:30
Ice cores and climate research
Anders Svensson, The Niels Bohr Institute, Ice and Climate,
Copenhagen
14:15
The Role of Annealing in Controlling the Physical
Form during Freeze-Drying
Raj Suryanarayana, University of Minnesota,
Minneapolis, MN, USA
14:45
15:15
11:30
Understanding the Challenges and Lessons Learned
in the Reconstitution of Highly Concentrated,
Freeze-Dried Proteins
Lyophilized Formulation and Process Development:
Industry Case Studies
Arnab Ganguly, IMA Life, Tonawanda, NY, USA &
Robin Bogner, University of Connecticut, Storrs, CT; USA
11:00
Panel discussion with audience participation
n REGULATORY
Moderator: Alan MacKenzie, Mercer Island, WA, USA
12:30
LUNCH / POSTER / EXHIBITION
13:30
Kinetic and Thermodynamic Aspects of Secondary
Drying
n PROCESS UNDERSTANDING AND CONTROL
COFFEE BREAK / EXHIBITION
11:30
Novel Characterization Approaches for Freeze-Dried
Products
14:00
Holger Grohganz, University of Copenhagen, Denmark
16:45
Novel Dry Powder Inhalation Systems Based on
Lyophilisates
14:30
Sarah Claus, Novartis, Basel, Switzerland
17:15
Panel Discussion with audience participation
Moderator: Alan MacKenzie, Mercer Island, WA, USA
19:30open end
SOCIAL EVENT EVENING at Gasthaus Schatten
Impact of Proposed Revision of Annex 15 on
Validation of Lyophilization
Thomas Peither, Maas&Peither AG, GMP-Verlag,
Schopfheim, Germany
12:00
Aggressive Freeze Drying and Controlled Nucleation
Application of Current FDA Validation Guidance to
Lyophilization – Development, Technology
Transfer and Manufacturing
Gerhard Winter, Ludwig-Maximilians Universität,
Munich, Germany
Edward Trappler, Lyophilization Technology, Ivyland,
PA, USA
Alan MacKenzie, Mercer Island, WA, USA
16:15
Primary Drying Optimization Using a ThreeDimensional Design Space
Lindsay Weigel, Steve Nail, Baxter Medical Products
R&D, Bloomington, IN, USA &
Arnab Ganguly, IMA Life, Tonawanda, NY, USA
Sajal Patel, MedImmune, Gaithersburg, MD, USA
12:00
Energy Transfer during Freeze-Drying in Dual
Chamber Cartridges
Christoph Korpus, Ludwig-Maximilians Universität,
Munich, Germany
Bakul Bhatnagar, Pfizer, Andover, MA, USA
Influence of Residual Water on Dynamics of FreezeDried Proteins: Insights from Simulations
Frederic Affouard, University of Lille, France
09:30
Controlled Nucleation: Benefits and Limitations for
Proteins and Cartridges
12:30
Ingo Presser, Boehringer Ingelheim, Biberach, Germany
15:00
COFFEE BREAK / EXHIBITION
EXHIBITOR SHORT PRESENTATIONS
18:30
BAVARIAN BUFFET AND BEVERAGES / EXHIBITION
Panel discussion with audience participation /
Conference Wrap-Up
Moderator: Alan MacKenzie, Mercer Island, WA, USA
13:00
Farewell
FREEZE DRYING OF PHARMACEUTICALS
& BIOLOGICALS
FREEZE DRYING OF PHARMACEUTICALS
& BIOLOGICALS
n CONFERENCE DESCRIPTION
n VENDORS / EXHIBITORS
Researchers from all areas of freeze-drying of pharmaceuticals
and biologicals converge to discuss critical aspects and new
developments in the field. Topics include material cheracterization, biotech formulation, process understanding and regulatory.
Networking and information exchange are enhanced by the
relaxed setting and focused fellowship.
Vendors/Exhibitors are welcome, please contact directly W. Friess or
G. Winter. We offer packages including space at the exhibition, a slot
for a company presentation, and one or more participants in the conference/short course.
Tuesday, September 23 & Wednesday, September 24
Short Course: Fundamentals of Pharmaceutical Freeze-Drying
Michael Pikal and Steve Nail, distinguished researchers in the
science of freeze drying, present a short course for those new to
the subject, giving insight into basic physics, process engineering, formulations aspects and more, spiced with personal
anecdotes from more than sixty years of practical experience.
Thomas Anchordoquy · University of Colorado Denver
[email protected]
Wolfgang Friess · Ludwig-Maximilians-Universität Munich
[email protected]
Alan MacKenzie · Mercer Island
[email protected]
Steven L. Nail · Baxter
[email protected]
Michael J. Pikal · University of Connecticut
[email protected]
Edward Trappler · Lyophilization Technology, Inc.
trappler@lyo_t.com
Gerhard Winter · Ludwig-Maximilians-Universität Munich
[email protected]
Wednesday, September 24
Social event evening at Gasthaus Schatten
7:30 p.m. – open end.
n HOTEL REGISTRATION
A limited contingent of hotel rooms is reserved at a special rate
at the Dorint Sporthotel (were the conference and the short
course take place) and the nearby Mercure Hotel in GarmischPartenkirchen. The reserved block of rooms for the Conference
will only be held until July 29, 2014. Requests for accommodations after this date will be subject to availability. Please make
reservations directly at the hotel and refer to our reservation
contingents.
Dorint Resort
Mittenwalder Str. 59 | 82467 Garmisch-Partenkirchen, Germany
Phone +49 8821 706 603 | www.dorintresorts.com
Keyword: Ludwig-Maximilians-Universität MUC
Mercure Hotel Garmisch-Partenkirchen
Mittenwalder Str. 2 | 82467 Garmisch-Partenkirchen, Germany
Phone +49 8821 756 0 | www.mercure.com
Keyword: LMU München
n CALL FOR PAPERS
Contributions for our poster Session on September 25 are very
welcome. Please send your abstract to
[email protected] until August 1st, 2014.
n ORGANIZING COMMITTEE
www.lyo-garmisch.de
FREEZE
DRYING OF
PHARMACEUTICALS
& BIOLOGICALS
SHORT COURSE AND CONFERENCE
September 23.–26., 2014
Dorint Hotel
Garmisch-Partenkirchen, Germany
n CONFERENCE REGISTRATION
KelCon GmbH · Ana Robinette
Tal 26 · 80331 München · Germany
Phone: +49 (0)89 2 03 55 01 72
Fax: +49 (0)89 2 03 55 01 77
E-Mail: [email protected]
For online registration please visit www.lyo-garmisch.de.
Presented by the Dane O. Kildsig Center
for Pharmaceutical Processing Research (CPPR),
a National Science Foundation Industry/University
Cooperative Research Center