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CONFERENCE

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7th Lyophilization Americas

Achieving optimum lyophilization processes. Where is the future of lyophilization heading?

15th - 16th October 2013, The Seaport Hotel, Boston, USA

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Background Info
Day 1
Day 2
Partners
Past Papers

Associate Sponsors

Media Partners

Background Info

Key Speakers
• Serguei Tchessalov, Principal Research Scientist, Pfizer
• Mayumi Bowen, Senior Engineer Pharmaceutical Processing Technology Development, Genentech Inc
• Dushyant Varshney, Senior Project Manager, Novartis
• Bingquan (Stuart) Wang, Senior Scientist, Genzyme
• Jeff Blue, Director, Vaccine Drug Product Development, Merck & Co. Inc.
• Anthony Gudinas, Senior Scientist, Pfizer
• Lotte McNamara, Senior Consultant, PAREXEL Consulting
• Andrew Parker, Associate Director, Molecular Profiles
• Renaud Janssen, Global Director of Scientific Affairs, Datwyler Pharma Packaging
• Andrew Birkmire, Process Development Manager, GEA Process Engineering
• Jean-Pierre Amorij, Program Manager Vaccine, Technology, Intravacc
• Larry Ulfik, President, Applewood Scientific
• Mark Shon, Services Director, SP Scientific

Lyophilization and freeze-drying are synonymous terms which are used interchangeably. Lyophilization is a widely applied process utilitized in the preparation of biopharmaceuticals and biologicals.

Lyophilization has in the recent years become a successful commercial process because it allows greater storage stability for otherwise labile biomolecules, provides a convenient storage and shippage format and following reconstitution rapidly delivers the product in its original formulation, ready for use. Examples of products which are commonly preserved by the process of lyophilization include: pharmaceutical and biotechnology drug formulations, nutraceuticals, cosmeceuticals, vaccines, biomaterials, blood plasma, bacteria and other microorganisms.

The lyophilization of drugs presents numerous business advantages:
• Although the principal change in lyophilization is water removal, the aim of freeze-drying pharmaceuticals is to stabilize the product. Lyophilization results in higher stability, greater temperature tolerance and a longer shelf-life for most pharmaceutical formulations which are unstable in aqueous solution.
• Lyophilization has a number of principal advantages over the conventional drying methods (crystallization, filtration, or precipitation) one of which is the preservation of chemical and biological potency, homogeneity in the final product and also allows ease of dispensing/metering before final packaging.
• Greater speed and completeness of rehydration in comparison with dry powder fills (an example of which is injectable penicillin)
• Accurate, sterile dosing into final product containers. For example, pharmaceutical solutions can be dispensed and sterile-filtered with a high degree of accuracy immediately before lyophilization, guaranteeing a precise dose.

The commercial process of lyophilization is fundamental in the biopharmaceutical industry, as it is estimated that over 50 % of biopharmaceuticals products are lyophlized in order for these unstable agents to be applied as therapeutic agents. Advancements in lyophilization technology facilitated by novel freeze-drying equipment designs and have been further advanced by modern computer/instrument control automation has resulted in tremendous growth in the technology and services sector.

In the year 2011, the US was the global leader in the lyophilization market for technology and services, attaining 40 % of the market share to be worth a total of $ 0.89 bn. It is predicted that the US market will continue dominate the lyophilization technology and services market with a growth of 8.7% in CAGR from 2011 to 2022, as in this period a number of injectable drugs and vaccines , currently in clinical trials enter the biopharmaceutical market.

Reasons to register:

• NEW by popular demand! 2 interactive panel discussions with experts!
- Are the product and process approaches similar for biologics and vaccines?
- What strategies are used to select between lyophilisation and spray-drying products?
• Assess opportunities presented by lyophilized therapeutics from development to commercialization
• Benefit from case studies of how to overcome formulation and stability hurdles in vaccines
• Understand how to establish correlations between CQA and CPP for lyophilized products
• Learn about the impact of headspace moisture on different lyophilization closures
• Discover how to design lyo-friendly formulations for biologics
• What are the rational choices to make when using excipients in lyophilized formulations?
• Determine whether the future of drug development lies with lyophilization or spray-drying
• Evaluate spray-dried biopharmaceutical powders for drug substance bulk storage
• Learn about new methodologies and applications for process scale-up
• What are the benefits of controlling nucleation in production freeze-dryers?
• Establish how to minimize the risk migration in the lyophilization process

Who should attend?

Presidents, Chief Executive Officers, Vice Presidents, Chief Scientific Officers, Directors, Business Development Managers, and Principal Scientists of:
• Freeze drying technology
• Vaccine/antibody/cell manufacturing
• Bioprocess research and development
• Chemical Engineering
• Process implementation and process engineering
• Stability testing
• 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
• Pilot plant operations

Venue:

The Seaport Hotel
One Seaport Lane
Boston
MA 02210
USA

Day 1

Day One, Tuesday, October 15th 2013

09:00 Registration and refreshments

09:30 Opening address from the Chair

09:40 Assessing the opportunities of lyophilized therapeutics from development to commercialization
• Key insights into formulation
• Analysing lyophilization process development

Bingquan (Stuart) Wang
Senior Scientist
Genzyme

10:20 Vaccine lyophilization: From lab-scale to manufacturing
• Primary drying and impact of freezing
• Evaluating subtle changes in the cabinet designs
• Assessing impact to product quality

Jeff Blue
Director, Vaccine Drug Product Development
Merck & Co. Inc.

11:00 Morning refreshments

11:20 Freeze drying of vaccines- case studies on overcoming the hurdles of formulation and stability
• Evaluating the use of lyophilization in vaccines
• Lyophilization for vaccine delivery with attention to needle free delivery

Jean-Pierre Amorij
Program Manager Vaccine Technology
RIVM Vaccinology

12:00 Transmission of moisture into the headspace of lyophilization vials – A study on different lyophilization closuresIdentifying the economics and cost effectiveness of freeze drying
Learn about the impact on headspace moisture from
• Regular moisture and low moisture lyophilization closures
• Coated and uncoated closures
• Different closure pre-treatment’s
• Different storage conditions of capped vials

Renaud Janssen
Global Director of Scientific Affairs
Datwyler

12:40 Networking lunch

13:40 Methods to enable correlations to be established between CQA and CPP for lyophilized products
• Use of spatially resolved techniques to augment data from in-line techniques
• Optimising the lyophilization cycle
• Novel methods to predict protein stability

Andrew Parker
Associate Director
Molecular Profiles

14.20 Design of lyo-friendly formulations for biologics
• Overview of formulation components recommended for lyophilization
• Rational approach to the stabilization of proteins during freeze-drying
• Design of economical and scalable lyophilization process

Serguei Tchessalov
Principal Research Scientist
Pfizer

15:00 Afternoon refreshments

15:20 The use of excipients in lyophilized formulations- what are the rational choices to make?
• Excipients in lyo-stabilization of diverse biologics & vaccines
• Relevance of physical form to functional role of excipient
• Screening and selection of excipients
• Excipients in development & marketed lyo-products

Dushyant Varshney
Senior Research Investigator
Novartis

16:00 Panel discussion: Are the product & process development approaches similar for lyophilized biologics vs. vaccines?

Panelists: Dushyant Varshney, Senior Research Investigator, Novartis
Serguei Tchessalov, Principal Research Scientist, Pfizer
Andrew Parker, Associate Director, Molecular Profiles

16:40 Closing remarks from the Chair

16:50 Networking drinks

Day 2

Day Two, 16th October, 2013

09:00 Registration and refreshments

09:30 Opening address from the Chair

Dushyant Varshney
Senior Research Investigator
Novartis

09:40 Lyophilization vs. spray-drying - where does the future lie?
• Overview of spray-drying process and history
• Comparison of spray-drying process to lyophilization
• Identifying impact of process parameters on product CQA
• Product quality risk assessment and process scale-up considerations

Andrew Birkmire
Process Development Manager
GEA Process Engineering

10:20 Spray-dried biopharmaceutical powders for drug substance bulk storage
• Applying powder-based biologics drug substances as an alternative storage solution overcomes technical and economic challenges
• Addressing the preparation of powder-based biologics drug substances based on spray-drying technology
• Evaluating the impact of spray-dryer design and sample formulation on spray-drying process
• Comparing drug quality between spray-drying and lyophilization processes

Mayumi Bowen
Senior Engineer Pharmaceutical Processing Technology Development
Genentech

11:00 Morning refreshments

11:20 Evolution in characterization of freeze-dryers: new methodology and application for process scale up
• Freeze dryer characterization: why and how.
• Challenges of characterization and the development of new methodologies.
• Application of characterization data from lab to commercial manufacture

Anthony Gudinas
Senior Scientist
Pfizer

12:00 ControLyo nucleation on-demand technology in production freeze dryers: retrofit strategy and results
• The demonstrated benefits of controlling nucleation
• The engineering requirements and strategy for retrofitting a production freeze dryer for ControLyo technology
• Results of scale-up studies done on retrofitted production dryers

Mark Shon
Services Director
SP Scientific

12:40 Networking lunch

13:40 Panel discussion: What are the industry models/strategies/stages for selection of ready-to-use vs. lyophilization vs. spray-dried products?

Panelists: Andrew Birkmire, Process Development Manager, GEA Process Engineering
Mayumi Bowen, Senior Engineer Pharmaceutical Processing Technology Development, Genentech
Jean-Pierre Amorij, Program Manager Vaccine Technology, Intravacc

14:20 Minimizing the risk migration in the lyophilization process- from the basics of product development to technology transfer
• Examining the implications of failing to reduce the risk migration in the lyophilization process
• How to eliminate risk early and avoid migration of risks into the lyophilization and development process and tech transfer programs
• Eliminating risk is a key endeavor from a regulatory and practical perspective
• Consider developing workable SOP's which can be done quickly and effectively:
- To uncover risks quickly before execution of key cycles in development
- To determine if all systems are "go" when transferring technology
• Challenge the system, check for errors using fault- finding analysis

Larry Ulfik
President
Applewood Scientific

15:00 Afternoon refreshments

15:20 Regulatory guidelines for lyophilization of biotherapeutics
Presentation points to be announced

Lotte McNamara
Senior Consultant
Parexel

16:00 Evaluating the use of reference materials in lyophilization

16:40 Chair’s closing remarks

16:50 End of Conference

Partners

Associate Sponsors

Datwyler
Datwyler's Sealing Solutions Division is a focused leading supplier of bespoke sealing solutions to global market segments, such as the automotive, pharmaceutical and civil engineering industries etc. Within the pharmaceutical industry, our main focus is on delivering innovative solutions for vaccines, diabetic care and biotechnology. With a global manufacturing footprint, sales in over 100 countries and more than 5,000 employees, the company generates an annual revenue in excess of 500 million Euro. For further information, please visit www.datwyler.com

SP Scientific
SP Scientific's VirTis + FTS + Hull = Freeze Dryer Innovation and Excellence. Our freeze dryer group is one of the most technically innovative and superior freeze drying manufacturers today. The company is focused on understanding the freeze drying needs of researchers everywhere and dedicated to providing top-quality equipment with superior application and technical support.For further information, please visit www.spscientific.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.InPharm.com

Sponsorship and exhibition opportunities

This event offers a unique opportunity to meet and do business with some of the key players in the pharmaceutical and biotech industries. If you have a service or product to promote, you can do so at this event by:
• H osting a networking drinks reception
• T aking an exhibition space at the conference
• Advertising in the delegate documentation pack
• Providing branded bags, pens, gifts, etc.

If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 7th Lyophilization Americas Conference, please contact us.
Damian Gorman, +44 (0) 20 7549 9934
damian.gorman@visiongainglobal.com

Past Papers

Speaker presentations are free to paying 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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