This years annual Lyophilization Conference will take place at the OAK BROOK HILLS RESORT in Chicago. IL and events will take place during September 13 - 19, 2003. Because it is truly an International Society, it is committed to hold its conferences in countries in various parts of the world (Beijing, China in 2004; Morocco in April 2005; Rio de Janeiro in September 2005 and Paris, France 2006 ). As a consequence, it may not be until 2007 before the Lyophilization Conference will again return to the United States.
The main events of the Conference are as
follows:
Four Day Conference
Three Day Lyophilization Seminar
One Day Workshops
Sponsors for this Conference
7:00 - 9:00 p.m. Early Registration
Opening of the Exhibits - with refreshments
7:00 - 10:00 a.m. Final registration
8:00 a.m. Opening of the Conference - Armansyah Tambunan, Ph.D.
Welcome by Society President - Thomas A. Jennings, Ph.D.8:10 a.m. Harold Meryman, M.D. (Invited Key Note Speaker)
"The Early Days Were More Fun!!!"
Biomedical Research Institute - USABiotechnology and Pharmaceuticals
Session Chairperson - Professor Louis REY, Ph.D. - Scientific Advisor - Switzerland
9:00 a.m I. Novoa, L. Rey, A. López, A. Gutiérrez, O. Mayo
"Development of a lyophilization process for pharmaceutical products at large scale"
National Center of Bioproducts - Cuba.9:30 a.m. Valeria Greco
"The influence of Glass Properties on Vial Failure During Lyophilization"
Alcan Packaging - USA9:45 a.m. David S. Baker, Ph.D.
"The use of non-aqueous solvents in freeze-drying of pharmaceutcals and biological products, and their effect on the frozen matrix, process development and formulation selection."
Pharmacia - USA10:00 a.m. Morning Coffee break
10:15 a.m. Paul Matejtschuk, Ph.D.
"Application of an Array of Analytical Methods in Support of the Freeze-Drying of Biological Standards"
National Institute for Biological Standards and Control - UK10:45 a.m. Mr. Yang Ting - Invited Speaker
"Lyophilization technology in technetium-99m kits production"
China Institute of Atomic Energy - China11:00 a.m. Charlotte Morgan Ph.D.
"Lyophilization of Precise Numbers of Microorganisms"
BTF-Decisive Microbiology, Australia11:30 a.m. Wilhelm Scigalla, Ph.D.
"Optimization of an Lyo-Cycle during Transfer and Scale Up of an IV Pharmaceutical Product".
Basilea Pharmaceutica Ltd - Switzerland11:45 a.m. B.Y. Shekunov - P. Chattopadhyay - J.S. Seitzinger
"Production of Powders for Respiratory Drug Delivery Using Spray-Freezing with Compressed CO2"
Ferro Corporation - Pharmaceutical Technologies - USA12:00 p.m. Lunch and Exhibits
Product Properties
Session - Chairperson - Joan May, Ph.D.
1:30 p.m. Paul Matejtschuk, Ph.D. Invited Speaker
"Residual Moisture and the Stability of Biological Standards"
Standards Division, National Institute for Biological Standards and Control -
National Institute for Biological Standards and Control - UK2:00 p.m. Dirk L. Teagarden, Ph.D.
"Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Non-aqueous Co-solvent Systems"
Pharmacia Corporation - USA2:30 p.m. D. Q. Wang, Ph.D.
"Impact of Product Properties on Stability of Lyophilized Protein Drugs"
Bayer Biological Products - U.S.A.2:45 p.m. Jos Corver, Ph.D.
"Monitoring Product Quality In-Line"
BOC Edwards - The Netherlands3::00 p.m. Afternoon - Coffee and Refreshment Break
3:15 p.m. Wendell Sun, Ph.D.
"The Dispersivity of Reactions in Freeze-Dried Products: Relevance to Formulation and Shelf-Life Prediction"
LifeCell Corp. -USA3:30 p.m. Joan C. May, Ph.D.
"Developments in the Measurement of Residual Moisture in Freeze- Dried Biological Products"
Center for Biologics Evaluation and Research, US FDA - USA4:00 p.m. Society Annual Meeting
President - Thomas A. Jennings - USA4:30 p.m. Poster Session
7:00 p.m. - 9:00 p.m. Society Reception - with live music
Dress Code: Suits for Gentlemen and Cocktail Dresses for Ladies or Appropriate Country Attire
Thermal Analytical Techniques Session Chairperson - Hanna Willemer
8:00 a.m. Ronald Petombo, Ph.D. (Invited Speaker) and Guilherme A. Mercado Ribeiro Lima
"Studies of molecular mobility and influence of process variables and freeze drying time in the quality of freeze dried Pintado fish."
Universidade de Ed Sao Paulo - Bazil8:15 a.m. Steve Bouffard, Ph.D.
"Optimization of the Lyophilization Process using Differential Scanning Calorimetry (DSC)"
PerkinElmer Life and Analytical Sciences - USA8:30 a.m. Schilder Gerhard
"Freezing of ion and protein solutions observed by electrical resistance measurement."
Steris GmbH - Germany8:45 a.m. Kevin Ward, Ph.D.
"The analysis of Formulations using Freeze-Drying Microscopy and Comparison with Alternative Methodologies - How does this relate to the Lyophilisation in the Real World?"
Biopharma Technology Limited - UKMiscellaneous
Session Chairperson- Armansyah Tambunan, Ph.D.
9:00 a.m. Armansyah H. Tambunan, Ph.D.
"Heating Characteristics During Freeze-Drying Process Of “JAMU” Ingredients"
Department of Agricultural Engineering, Bogor Agricultural University, INDONESIA9:15 a.m. Ms. Marjorie Janssen
"Investigating Floral Freeze Drying and the Steps for Processing"
Crystal Rose - Canada9:30 a.m. Ofero Caparino
"Characteristics And Quality Of Freeze-Dried Mango Powder Pre- Frozen At Different Temperatures"
Bureau of Postharvest Reseach and Extension - Philippines10:00 a.m. Morning Coffee Break
Regulatory Issues
Session Chairperson - Teresa Jimenez
10:15 a.m. Ms. Teresa Jimenez
"Electronic Inspection Reports & FDA-483 (Turbo EIR & Turbo FDA-483)"
Regulatory & Compliance Consultant - Puerto Rico10:45 a.m. Ms. Rebeca Roddriguez Invited Speaker
"FDA INSPECTION OF LYOPHILIZATION PROCESSES"
Food and Drug Administation - USA11:15 a.m. Ms. Anne Johnson Invited Speaker
"FDA Findings in Lyophilization Processes - A Compliance/Enforcement Perspective "
Food and Drug Administation - USA11:45 a.m. Lunch and Exhibits
1:00 p.m. Tour of Chicago
Biotechnology and Pharmaceuticals
Session Chairperson - Professor Louis REY, Ph.D. - Scientific Advisor - Switzerland
9:00 a.m. M-C. Bellissent-Funel - Invited Speaker
"Behavior of water confined in lyophilized biological macromolecules"
Laboratoire Leon Brillouin - FranceEquipment
Session Chairperson - Miquel Galán
9:30 a.m. Yossi Shapira
"Sublimation rate- a key parameter in a successful freeze drying cycle, Freeze Dryer design, easy method for studying it"
Teva Pharm. Industries - Israel10:00 a.m. Morning Coffee Break
10:15 a.m. Charles D. Dern
"Surface roughness measurement methods"
Hull Company - USA10:30 a.m. Michael Larson and Rick Ervin
"A new instrument for rapid moisture analysis of lyophilized products"
Arizona Instrument - US10:45 a.m. Dr. Georg-Wilhelm Oetjen and Gerhard Schilder
"Automatic loading and unloading of freeze-dryers and consequences for the control of the freeze drying process"
Steris GmbH - Germany11:15 a.m. David Couriel
"Historical overview indicating how technical advances have been incorporated into freeze dryers in Mexico"
Benico SA - Mexico11:45 a.m. Ana Bacaoanu, Ph.D.
"Steam sterilization of the stationary large-scale freeze- dryers"
Gh. Asachi Technical University of Iasi - Romania12:00 p.m. Lunch and Exhibits
Equipment
Session Chairperson - Miquel Galán
1:30 p.m. Cyril LEENHARDT
“Freeze-dryer Loading and Unloading systems”
USIFROID - FranceBiologicals
Session - Chairperson - Irina Bakaltcheva, Ph.D.
2:00 p.m. Ingo Heshel, Ph.D. Invited Speaker
"Freeze-Drying of Red Blood Cells: A Review of Research Results from a Technical Perspective"
Matricel GmbH, Germany2:30 p.m. Irina Bakaltcheva, Ph.D.
"Developing Matrices for Red Blood Cells Lyophilization"
Walter Reed Army Institute of Research - USA3:00 p.m. Afternoon Coffee Break
3:30 p.m. Caballero I, Tilquin B, Prieto E, Pérez N, Castillo A, Miralles Y and Altanés S
"Radiosensibility study of freeze-dried antibody to gamma irradiation."
Center of Molecular Immunology - Cuba4:00 p.m. Wendell Q. Sun*, Chris Wagner and Jerome Connor
"Kinetic Stabilization of Frozen Human Red Blood Cells for Freeze-Drying"
LifeCell Corporation, Branchburg, New Jersey - USA4:30 p.m. End of Session
7:00 p.m. - 12:00 p.m. Annual Banquet - with special live entertainment - music and dancing.
Dress Code: Suits for Gentlemen and Cocktail Dresses for Ladies or Appropriate Country Attire
Biologicals
Session Chairperson - Irina Bakaltcheva, Ph.D.
9:00 a.m. Rachanee O'Charoen, M.D. - Invited Speaker
"Lyophilized Plasma and Cryoprecipitate"
National Blood Center, Thai Red Cross Society (sponsored by Henry Jackson Foundation for Advancement of Military Medicine)9:30 a.m. Victor Bronstein, Ph.D.
"Preservation by foam formation as an alternative to freeze-drying"
Universal Stabilization Technologies, Inc. - USA10:00 a.m. Morning Coffee Break
10:30 a.m. Ingo Heshel, Ph.D. - Invited Speaker
"Directional Solidification as the first process step during freeze-drying: What are the advantages in comparison to classical freezing?"
Matricel GmbH, Germany11:00 a.m. Vladimir Guilmanov, Ph.D.
"Development of a Flexible Container (Bag) for Lyophilization of Blood Products"
Foster-Miller, Inc., USA11:15 a.m. Tatiana Samuylova
"Protective Medium for Dehydration and Preservation of Biologicals"
Auburn University, USA11:30 a.m. Dr. Lou Zhifu and Ms. Hung Wei
"Invitation to Attend the Third Annual Lyophilization Conference 2004 in Beijing"
China Institute of Atomic Energy - Beijing11:45 a.m. Closing of Conference - Armansyah Tambunan, Ph.D.
12:00 p.m. Lunch and Exhibits
1:30 p.m. Closing of Exhibits
Please note William T. Roedel (Telestar (USA), Inc) will act as the Society's Offical Photographer
All technical papers presented at the Conferences may appear in an issue of the American Pharmaceutical Review or on its web site at www.americanpharmaceuticalreview.com. The American Pharmaceutical Review is serving as the Official Publication for the Society
[Registration by Credit Card - Check or Wire Transfer] [Go To Seminar or Workshops]
The seminar has been revised and up-dated. It will be presented using Microsoft PowerPoint and each attendee to the seminar will receive complete set of the course notes, a copy of the book Lyophilization- Introduction and Basic Principles and their personal copy of the PowerPoint presentation on a CD-ROM disk. Deadline for Seminar registration is August 29, 2003
| Time | Seminar Schedule |
| 08:30-09:00 | Registration + Coffee |
| 09:00-10:15 | Introduction, historical review and product formulation |
| 10:15-10:30 | Morning refreshment break |
| 10:30-12:00 | Role of water, review of phase changes |
| 12:00-13:30 | Lunch break |
| 13:30-15:00 | Thermal analysis, differential thermal analysis (DTA) |
| 15:00-15:15 | Afternoon break |
| 15:15-16:30 | Electrothermal analysis |
| Time | Seminar Schedule |
| 08:30-09:00 | Review of previous sessions |
| 09:00-10:15 | Freezing process |
| 10:15-10:30 | Morning refreshment break |
| 10:30-12:00 | Primary drying process |
| 12:00-13:30 | Lunch break |
| 13:30-15:00 | Secondary Drying |
| 15:00-15:15 | Afternoon break |
| 15:15-16:30 | Product Properties |
| Time | Seminar Schedule |
| 08:30-09:00 | Review of previous sessions |
| 09:00-10:15 | Principles of vacuum technology |
| 10:15-10:30 | Morning refreshment break |
| 10:30-12:00 | Container-Closure system |
| 12:00-13:30 | Lunch break |
| 13:30-15:00 | Vacuum Freeze Dryer - Instrumentation |
| 15:00-15:15 | Afternoon break |
| 15:15-16:30 | Final Review |
For those just entering the field of lyophilization it will provide a broad overview of the entire process and the interrelationship between the formulation, the lyophilization and the drying equipment and instrumentation. For individuals with more experience in the field of lyophilization it will broaden their depth of understanding and grasp of this very complex and often puzzling field of science. The seminar is particularly directed at those individuals responsible for developing lyophilized formulations, QA and QC personnel responsible for the lyophilized products, production personnel and members of the managerial staff.
[Registration by Credit Card - Check or Wire Transfer] [Go To Conference or Workshops]
A lyophilization workshop differs from that of the seminar in that there is no rigid format. The topics and content of the workshop is completely dictated by those attending the session. While those just entering the field of lyophilization will find the workshop to be enlightening and the sometimes heated debate between those attending to be entertaining at times, the workshop is really geared for those knowledgeable in the field of subject but need additional information on a particular topic to round-out their comprehension of the subject. Because of the latter statement, the workshop is best described as an interactive workshop. Since the content of each workshop will differ depending on the experience of those attending, it is not possible to prepare any notes for the session.
Because of the large number of topic areas that can be covered during any one work shop session, the conducting of such a session has to be conducted by an experinced Monitor. The Monitors for these have been carefully chosen because they possess the necessary educational background and broad experience in the science and technology of the subject to conduct such a workshop. While there is no formal format to a workshop, Each Monitor will have ample visual aid materials with him in order to provide information on a topic or a working model to serve as a base for the discussion.
| Time | Program |
| 08:00-08:30 | Registration + Coffee |
| 08:30-10:30 | Overview of the subject by Monitor(s) |
| 10:30-10:45 | Morning refreshment break |
| 10:45-12:00 | Interactive session |
| 12:00 - 1:30 | Lunch (provided by Society) |
| 1:30 - 3:00 | Interactive session |
| 3:00 - 3:15 | Afternoon refreshment break |
| 3:15 - 4:00 | Interactive session |
| 4:00 - 4:30 | Wrap-up of the workshop by Monitor(s) |
Lyophilizers
Commissioning and Validation -
Miquel Galán - Spain
Freeze Dryer
Maintenance - Lawrence A. Ulfik - USA
Sterilization Of Freeze-Dryers - Dr. Kevin Murgatroyd - United Kingdom
Leak Detection - Peter
Leare - United Kingdom
Contract Manufacturing of Lyophilized Products -
Dr. Wilhelm Scigalla - Germany
Dr.
Narlin B. Beaty - USA
[Registration by Credit Card - Check or Wire Transfer] [Go To Conference or Seminar]