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CONFERENCE

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3rd Annual Lyophilization

Ensuring optimum formulations for pharmaceuticals and biologicals

24th - 26th February 2010, Boston Harbor Hotel at Rowes Wharf, Boston, USA

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Background Info
Workshop
Day 1
Day 2
Partners
Past Papers

Silver Sponsor

Associate Sponsors

Media Partners

Background Info

Key Speakers
• Nicholas W. Warne, Director, Formulations, Wyeth
• David A. Hamilton, Manager, Pharmaceutical Technology, Global Technical Services, Merck & Co.
• Serguei Tchessalov, Principal Research Scientist , Wyeth Biotech
• Suman Luthra, Senior Scientist, Pfizer
• Willow R. DiLuzio, Senior Engineer, Formulation Sciences, Sterile Products, Millennium: The Takeda Oncology Company
• Alexander M. Klibanov, Novartis Endowed Chair Professor of Chemistry and Bioengineering, Massachusetts Institute of Technology
• Larry Gatlin, Director, PK, LLC
• Charlie Tang, Fellow Scientist, Regeneron Pharmaceuticals
• Dr Paul Stewart, President & CEO, Telstar North America, Inc.
• J. Jeff Schwegmann, Founder & Chief Executive Officer, AB Biotechnologies
• Enric Jo Cardoso, Plant Manager, Reig Jofré Group
• Christophe Wagner, Research & Development Director, SGD Group
• Jaime Cobo, Area Sales Manager, Wilco
• Walt Pebley, Director of Business Development, Oregon Freeze Dry

Without lyophilization, nearly 60% of biopharmaceuticals including plasma, vaccines and antibodies could not be commercially available. With a greater trend to outsource manufacturing and more biologicals requiring freeze-drying, this $1.5bn market is set to maintain its year-on-year double digit growth.

Although the commonest way to ensure longevity and stability for complex molecules, lyophilization remains costly, complex and facility-intensive. Fine-tuning cycle parameters and trial-and-error experimentation also means the procedure remains as much of an art as a science. As reducing development time becomes increasingly important in today’s economic climate, a rational, empirical approach to cycle design can save you time and money, especially when upscaling. More importantly, a robust lyophilization cycle will guarantee a safe and effective product.

Mastering these complex and inter-related requirements is no mean feat and Visiongain’s 3rd Annual Lyophilization conference provides distilled intelligence on formulation and process development for biopharmaceuticals. With a workshop and sessions led by experts, you will gain a thorough understanding to provide the best outcome for your business. Case studies from industry will offer strategic insights to help you optimize key input and output parameters, and troubleshoot challenges with temperature-sensitive molecules or solid proteins. In addition you will also gain the latest insights into:

• Rational approaches to pre-formulation and formulation process
• Designing product-specific freezing and sublimation and desorption protocols
• Improving analytical methodology to characterize frozen systems and freeze-dried solids
• Characterizing the final dried formulation
• Accurately predicting product stability at the intended storage temperature
• Ensuring cGMP, QbD, QC and QA
• Consistently achieving the desired product quality
• Improving process engineering dynamics and scale up
• Troubleshooting manufacturing problems
• PAT in manufacturing and the lab

Who will be there?

Presidents, Chief Executive Officers, Vice Presidents, Chief Scientific Officers, Directors, Business Development Managers, and Principal Scientists of:
• Research and development
• Freeze-drying process
• Process implementation and process engineering
• Compliance
• Sterile production
• Quality assurance and quality control
• Standardisation science
• Drug formulation
• Active pharmaceutical ingredients
• Pharmaceutical production
• Manufacturing and engineering
• Licensing
• Product development
• Outsourcing/contract manufacturing
• Dried technology
• Packaging and labelling
• Vaccine/Cell/Tissue manufacturing
• Pilot plant operations

Venue
Boston Harbor Hotel at Rowes Wharf, 70 Rowes Wharf, Boston, MA 02110
Phone: 617.439.7000, Fax: 617.330.9450, www.bhh.com
Guest Room Reservations: 800.752.7077, Email: reservations@bhh.com

Discounted accommodation is available for Visiongain attendees at the Boston Harbor Hotel at Rowes Wharf for $225 plus taxes per guest room per night. Reservations can be made by calling (800) 752-7077 and referencing the code: Visiongain, for the special group room block. Failure to cancel a reservation 24 hours prior to the arrival date will result in a charge of one night’s room and tax to your credit card. This offer is subject to room availability.

Workshop

Pre-conference Interactive Workshop, Wednesday 24th February, 2010

Using thermal characterization data to troubleshoot problematic formulations and or lyophilization cycles

Led by: J. Jeff Schwegmann
Founder & Chief Executive Officer
AB BioTechnologies

Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 15:00 Workshop
Timing includes lunch and refreshment breaks

The purpose of the workshop is to allow you to engage in knowledge sharing with your peers in a smaller, less formal environment than the main conference. As such, the audience size will typically be no more than 20 participants in order to enable maximum interaction between the workshop leader and the delegates. The format is also more interactive, with less emphasis on ‘lecture-style’ presentations and more emphasis on group discussions, exercises and Q&A sessions.

Workshop Format

It is not unusual for lyophilized products to occasionally fail during manufacturing at the commercial level due either to poor physical characteristics or to degradation. By understanding the thermal characteristics of the formulated product, it is possible to specifically identify the problem, troubleshoot, and correct problems with either the formulation or the lyophilization cycle itself.

This workshop will be an open, lecture style format that will allow interaction and open discussion between the workshop leader and participants in a round table format. The workshop will include lectures and group discussion on the physical properties of materials, thermal characterization techniques, formulation design for lyophilized products, followed by case studies of failed products. The group will work through the case studies in an attempt to identify the problems, suggest the reasons for failure, and determine a plan of action for fixing the problems to prevent future failures.

Lessons Learned
• Understanding the difference between crystalline and amorphous systems and the associated critical temperatures
• Analytical techniques used for thermal characterization
• Understanding proper formulation development of freeze-dried products
• Applying thermal characterization data to identify physical defects in products
• Taking an empirical approach to fixing problematic formulations and lyophilization cycles

About your workshop leader:
J. Jeff Schwegman, Ph.D. is currently the founder and chief executive officer of AB BioTechnologies where he specializes in speaking and consulting in parenteral pre-formulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules. He also holds patents and develops new technologies within the lyophilization field. Dr. Schwegman received his BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington Indiana, where he gained experience in analytical, formulation and process development. In 1999 he began graduate study in the Department of Industrial and Physical Pharmacy at Purdue University under the direction of Dr. Steve Nail, where his focus of research involved studying changes in the physical structure of biological molecules during lyophilization. Dr. Schwegman received his PhD from Purdue University in 2003, and returned to Bloomington where he worked at Baxter Pharmaceutical Solutions as a Research Scientist in the Pharmaceutical Development group. In November 2005, he left Baxter and formed BioConvergence LLC with 3 other founders which specialized in developing new formulations and manufacturing processes for parenteral products. In February 2008, he left BioConvergence, which has become a successful company, to form AB BioTechnologies. He is currently the course Director for a 3-day course called Lyophilization Technology which he teaches through the Center for Professional Advancement. He routinely lectures around the world on formulation, stabilization and process development of lyophilized products. He has also been an active member of AAPS since 2001.

AB BioTechnologies
AB Biotechnologies is a small life sciences company located in Bloomington Indiana. The company offers consulting and teaching services in the development of parenteral products including solutions, suspensions, emulsions, and lyophilized products. Additionally, AB Biotechnologies offers in-house, hands on courses in formulation and process development of freeze-dried products. AB Biotechnologies has recently partnered with a local contract manufacturing company, and can now offer complete preformulation, formulation, and process development of new drug products. Additionally, Pre-Clinical, Clinical, and commercial manufacturing are available through the contract manufacturing partner.

Day 1

Day One, Thursday, 25th February, 2010

09:00 Registration and refreshments

09:30 Opening address from the Chair

Nicholas W. Warne
Director, Formulations
Wyeth

09:40 Lyophilization of biologicals- an introduction
• Essential concepts
• Equipment required
• Sequence of Operations

David A. Hamilton
Manager, Pharmaceutical Technology, Global Technical Services
Merck & Co.

10:20 Main manufacturing challenges in lyophilisation processes
• Main failures with lyophilised production: the real world
• Integration of quality challenges into cost challenges
• From basic product knowledge to product release

Enric Jo Cardoso
Plant Manager
Reig Jofré Group

10:50 Morning refreshments

11:10 Lyophilization and its denaturation stresses
• Denaturation stresses during lyophilization
• Monitoring protein denaturation upon lyophilization
• Reversibility of freezing or lyophilisation-induced protein denaturation

Charlie Tang
Fellow Scientist
Regeneron Pharmaceuticals

11:50 Rational choice of excipients for use in lyophilized products
• Practical Sources for identifying acceptable excipients, route of administration, and concentrations
• Understanding and characterizing the thermal properties of different excipients
• Blending excipients to improve the thermal characteristics of a formulated product

J. Jeff Schwegmann
Founder & Chief Executive Officer
AB BioTechnologies

12:30 Networking lunch

13:30 Impact of sub-Tg thermal annealing on stabilization of amorphous pharmaceuticals
• How does structural relaxation affect molecular mobility in amorphous systems?
• Is it possible and practical to stabilize the drugs by promoting structural relaxation through annealing?
• Case studies with pharmaceutical examples of stabilization of amorphous drug products using annealing

Suman Luthra
Senior Scientist
Pfizer

14:10 Cryo- and lyo-protection of proteins by stabilizers
• Stabilizers for cry- and lyo-protection
• Mechanisms of protein stabilizers during lyophilization
• Cold denaturation of proteins

Willow R. DiLuzio
Senior Engineer, Formulation Sciences, Sterile Products
Millennium: The Takeda Oncology Company

14:50 Near infrared technology for residual moisture measurement in the cake, and laser absorption for oxygen measurement in the headspace. PAT on freeze dried vials.
• New developments in automated inspection technology
• Technologies overview and discussion
• Real test data from a freeze drying environment

Jaime Cobo
Area Sales Manager
Wilco

15:10 Meet the exhibitors and afternoon refreshments

15:30 Alternatives to freeze-drying
• Lyophilization is a long, complicated batch process with multiple opportunities for product failure
• Other processes have now evolved to the point that they can be seriously considered as alternatives to lyophilization
• Spray drying processes are most competitive with lyophilization- they are now amenable to sterile and even cytotoxic products

James Searles
Director of Process and Product Development
Aktiv-Dry

16:10 Panel discussion- complementary and alternative methods for drying biopharmaceuticals
Topics will include foam drying, spray-drying, percolatiove vacuum-drying, inert spray-drying and spray freeze-drying. Please email any questions you have for the panel to: john.shah@visiongainglobal.com.

Panelists: Andrew Birkmire, Process Development Manager, GEA Pharma Systems , A division of GEA Process Engineering
Maik Guttzeit, Team Leader, Validation, GEA Lyophil
James Searles, Director of Process and Product Development, Aktiv-Dry
Igor I. Katkov, Chief Scientific Officer and Owner, CELLTRONIX, Head of Cryobiology and Biopreservation, Burnham Institute for Medical Research

16:50 Closing remarks from the chair

17:00 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2

Day Two, Friday, 26th February, 2010

09:00 Registration and refreshments

09:30 Opening address from the Chair

Nicholas W. Warne
Director, Formulations
Wyeth

09:40 Effect of solute, concentration and solution fill height on incidence of vial breakage during freezing and freeze drying: A vial parameter study
• Insight into factors related to vial breakage
• Aspects of product design leading to vial breakage
• Contributing factors of processing parameters
• Variables to consider to prevent vial breakage

Christophe Wagner
Research & Development Director
SGD Group

10:10 Structure and degradation of lyophilized proteins
• Reversible vs. irreversible protein denaturation upon lyophilization
• Deterioration of lyophilized proteins
• Structure of lyophilized proteins

Alexander M. Klibanov
Novartis Endowed Chair Professor of Chemistry and Bioengineering
Massachusetts Institute of Technology

10:50 Morning refreshments

11:10 Case study: Preservation of form and functionality in the use of lyophilization

Walt Pebley
Director of Business Development
Oregon Freeze Dry

11:30 Fill and finish of lyophilized drug products: issues, trends and innovation
• Lyophilized products: Specific fill & finish issues
• Compliance management: trends
• LyoSeals as a quality, compliance and process optimization tool

Philippe LeGall
Director, Sales and Marketing
Biocorp

11:50 Process capability in lyophilization
• Moisture mapping
• Vacuum leak rate
• Visual inspection defects

David A. Hamilton
Manager, Pharmaceutical Technology, Global Technical Services
Merck & Co.

12:30 Networking lunch

13:30 A broadly applicable technology for the stabilization of vaccines and biopharmaceuticals
• Thermal stabilization of both whole and sub-unit viral vaccines and other biopharmaceuticals; case studies
• Ease of integration into existing cGMP lyophilization manufacturing processes
• Benefits of Stabilitech technology

Stephen Ward
Director of Development
Stabilitech

13:50 Ensuring quality by design (QbD) in manufacturing using advanced PAT techniques
• Designing an optimal and robust process using design of experiment (DoE)
• Megavariate monitoring for process control
• Predicting final quality in real time

Nirav Shah
Senior Application Specialist
Umetrics

14:10 Lyophilization model: Status, use, and the future
• The current status
• Use in process development
• The future of lyophilization modeling

Larry Gatlin
Director
PK, LLC

14:50 Afternoon refreshments

15:10 Design-related aspects of lyophilizer scale-up
• Determination of critical scale up aspects
• Influence of parameters and dimensions
• Manufacturer involvement in scale up process
• Strategic design of lab and pilot lyophilizer

Maik Guttzeit
Team Leader, Validation
GEA Lyophil

15:30 Lyophilization cycle scale-up: development to commercial manufacturing
• Characterization of freeze-dryers: temperature heterogeneity within the chamber, the sublimation tests and vial heat transfer coefficient measurements
• Application of modeling to lyo process development and scale up. Robustness study as a tool for identification of the design space boundaries.
• Examples of process scale up and tech transfer

Serguei Tchessalov
Principal Research Scientist
Wyeth Biotech

16:10 Case study: CFD lyophilization plant modelling
• Accounting for variables in the transport processes present in the lyophilization cycle
• Simulating the impact of different process conditions in the cycle operation
• Process and hardware optimization from initial design

Dr Paul Stewart
President & CEO
Telstar North America, Inc.

16:50 Chair’s closing remarks

17:00 End of conference

Partners

Silver Sponsor:

SGD Group
SGD's Pharmaceutical Glass division is a quality partner and an innovation resource to most pharmaceutical and biotech companies worldwide. SGD's commitment to quality is the foundation of our business strategy; the most recent example: SGD was the first to achieve ISO 15378 at each of its pharmaceutical glass manufacturing facilities.
SGD's latest development, EasyLyo™ vials, is aimed at driving productivity increases during the Lyophilization process. SGD recognized that vial breakage of traditional, small volume vials, was a major problem in many Lyophilization cycles and developed the SGD's EasyLyo™ vial line to be the "survivor vial" in the most demanding processes.
Learn more about SGD at: www.sgd-pharma.com

Associate Sponsors:

Reig Jofré Group
Reig Jofré Group is a leading CMO, providing Freeze Dried products worldwide. Our services include dossier development and licensing out globally, lyophilisation R&D services, process development, cycle optimisation, manufacturing and analytical services to global pharmaceutical, biotechnology and branded pharmaceutical companies.
With three plants in Europe and more than 500 employees, Reig Jofré’s capabilities cover products in different dosage forms, as well as specialised capabilities in aseptic filling, lyophilisation, ß-Lactams and cephalosporins. Reig Jofré has a dedicated client service team working for more than 160 worldwide clients, from large multinationals to small-medium size local firms. For further information, please visit www.reigjofre.com

WILCO AG
WILCO AG of Switzerland supplies both leak detection and laser based headspace analysis systems for both liquid and solid filled products, such as vials, ampoules, syringes, BFS.
Combined with pressure and vacuum decay, force sensor technology for flexible products such as blisters and an activation system for MDI's, WILCO AG provides testing solutions for all types of pharmaceutical products.
An integratable NIR (Near Infrared) sensor allows for a direct moisture measurement in a lyo cake.
The various technologies are implemented into either fully automatic, high speed in-line or off-line machines built by WILCO AG, or are used for laboratory purposes. For further information, please visit www.wilco.com

Biocorp
Biocorp specializes in the development and production of innovative packaging and drug delivery solutions for sterile drug products. Biocorp key product is LyoSeal®.
Lyoseal® is an innovative cap designed to crimp-seal vials in class A, either inside the freeze dryer chamber for lyophilized drug products, or immediately after stoppering for liquid parenterals. By design LyoSeal® offers early container closure integrity, product protection, compliance with new crimping regulation & process optimization. For further information, please visit www.biocorp.fr

Oregon Freeze Dry
For further information, please visit www.ofd.com

Umetrics
Umetrics is a world leader in multivariate technology, providing software for design of experiments (DOE) and multivariate data analysis (MVA). Umetrics offers complete solutions for both off-line and on-line data analysis (continuous and batch processes), all supported by training and consulting services. Umetrics is a subsidiary of MKS Instruments, Inc. (NASDAQ: MKSI), a worldwide provider of monitoring and control technologies.
More information can be found at Umetrics web page www.umetrics.com

Media Partners:

PharmiWeb.com
PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGY EUROPE
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the main goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com

Future Pharmaceuticals
Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries' top issues and the solutions top-tier vendors can provide. For further information, please visit www.futurepharmaus.com

InPharm
InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.In-Pharm.com

Pharma Connections Worldwide
Pharma Connections Worldwide® is the leading professional business networking website focused in the Pharmaceutical, Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for delivery of premiere content coupled with the right clientele in order to facilitate business development opportunities among industry professionals responsible for making key decisions in a global marketplace. For further information please visit www.pharmaconnections.com

Pharmaceutical Manufacturing and Packing Sourcer
Pharmaceutical Manufacturing and Packing Sourcer (PMPS) is a specialist journal designed to provide worldwide coverage of a range of topics relating to the pharmaceutical manufacturing and packaging sector. Web: www.samedanltd.com, Email: lee@samedanltd.com

Enquiries

If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 3rd Annual Lyophilization Conference, please contact:
Ronald Magali, +44 (0)20 7549 9934
ronald.magali@visiongainglobal.com

Past Papers

Speaker presentations are free to delegates. If you are unable to attend the event, the presentations are published two weeks after the event and are available to purchase.

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