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The SAE Media Group is pleased to invite you to the 5th Annual Lyophilization USA Conference arranged to take place on the 23rd and 24th October 2019, in Boston.
The current list of FDA-approved biopharmaceuticals contains up to 50% of injectables and approximately a third of all parenterals being lyophilized, which suggests it is the optimal way of ensuring stability in products that are unstable in aqueous solution. This instability or degradation can result in suboptimal product performance and even toxicity in worst cases indicating the need for lyophilization despite it’s inherently expensive running costs and time-consuming process.
However, despite being a relatively old process, there is much need for improvements to circumvent the high costs and extended process times with much room for innovation. Next year’s projections for the lyophilization equipment market are approximately $5.7 billion, which is 8% CAGR. This surge is fuelled by the urge to perfect lyophilization processes in areas that characterise the product to better inform formulation and process developments while consequently improving efficiency and reducing capital investment.
Join us this year to explore novel and developing technologies that tackle the most pressing challenges and push innovation in world of lyophilization. Benchmark and network with industry leaders and discuss the most up to date and relevant topics that delve into alternative lyophilization approaches, applied statistical modelling, fresh views on scaling up and tech transfer, pre- and post-product characterization. regulation and beyond.
 


 Participating in this year’s SMi Group Lyophilisation USA 2019 conference provides a chance to connect with research and industry leaders with the aim of tackling the most pressing hurdles in multiple areas of interest within lyophilisation:
- Gain valuable insight into the most current challenges and considerations when working with highly concentrated and sensitive formulations
- Explore new and innovative approaches in model-based studies that utilise the power of statistical analysis to improve process development and understanding
- Discuss the future outlook of lyophilization through trends in alternative approaches
- Discover updates on the leading PAT technologies such as controlled nucleation, continuous freeze drying, low-frequency Raman, vacuum-foam drying and more.
- Listen to key opinion leaders and experts from regulatory bodies speak about expectations and the assessment of reliable technologies in the market
 

VPs, Directors, Chiefs, Heads, Principals, Managers and Analysts of:
• Lyophilization/Freeze-drying
• Formulation Scientists
• Principal Scientist
• Process Development/Engineer
• Sterile/Fill-Finish
• Production
• PAT
• CMC
• Chemistry
• Manufacturing
• Quality Assurance/QA

Amatisgroup; Arlenda; Aznil Telstar Technologies, SLU; Abbott Healthcare Products BVá; BioNTech; Baxter SA; Bayer A G; Biofire Diagnostics; Biopharma Group; BioPharma Technology; Boehringer Ingelheim; Boehringer-Ingelheim; Bristol-Myers Squibb; BSP PHARMACEUTICALS Srl; BUCHI UK Ltd ; DeMontford University; DSM; Ferring Pharmaceuticals A/S; Fresnius Kabi Austria GmbH; F. Hoffman-La Roche Ltd.; GEA Process Engineering; Genzyme Ireland Ltd; GlaxoSmithKline; GlaxoSmithKline plc; GSK; GSK Manufacturing S.p.A.; Hosokawa Micron BV; Imperial College London; LFB Technology; INDATECH SAS; Janssen Pharmaceutica NV; MedImmune; MedImmune Inc.; Merck KGaA; Mylan; NIBSC; Novo Nordisk; OPTIMA pharma GmbH; Pacifi Ltd; Pfizer Inc; Pliva Croatia Ltd; RheaVita BV; Roche; Roche Pharmaceuticals; Sandoz GmbH; Syngenta Limited; TEVA Pharmaceuticals; University College Cork (UCC); University Of Central Lancashire; University of Ghent; Vetoquinol SA; Xellia Pharmaceuticals ApS;
 

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Evgenyi Shalaev, Executive Director, Allergan Plc

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9:10

A new model to investigate the growth of ice crystals and dynamics of freeze concentration in bulk protein solutions

Tai Hsi Fan, Associate Professor , University of Connecticut

• Understand the issue of redistribution and segregation of proteins between ice crystals during freezing resulting in a negative impact on protein stability
• Introducing a new phase-field model that examines the morphology, transport mechanisms, and interplay behind solute exclusion from ice crystals, high viscosity of the solution and limited space between crystals
• Interpretation of results, computational method, and further development across spatial and temporal scales
 

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9:50

Mass Spectrometer as process analytical tool and silicon oil detector

Alexander Tambovzev, Project Engineering and Development Leader, OPTIMA pharma GmbH

• Mass spectrometer is powerful and well known technology
• Unfortunately, the usage of it in freeze drying is often limited only by silicon oil leakage detection during system leak test
• Integration the mass spectrometer in entire freeze drying process as additional measurement equipment can extend process understanding and improve process quality control
 

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10:30

Morning Coffee

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11:00

Role of water in (in)stability of freeze-dried products: beyond molecular mobility concept

Evgenyi Shalaev, Executive Director, Allergan Plc

• Water is a major factor which influences stability of lyophilized proteins
• In addition to plasticizing effects, water can cause deterioration of freeze-dried proteins via catalysis of deamidation and other chemical reactions
• Water can also be a protein stabilizer, by preventing dehydration-induced changes in the higher-order structure
 

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11:40

Preventing Cross Contamination during Lyophilization

Richard Denk, Head Sales Containment, Skan

• What are highly potent/toxic Biopharmaceutical Products
• What are the GMP and Occupational Safety Requirements
• How to prevent Product Contamination during loading the Lyo
• Cleaning Requirements and Occupational Safety Requirements
 

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12:20

Networking Lunch

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13:20

Spray freeze-drying – Next Generation Drying Technology

Fawziya Ali, Senior Associate Scientist, Pfizer

• Lyophilization, the gold standard drying technology, has several limitations such as lengthy drying durations and low energy efficiency
• Spray freeze-drying presents a promising alternative drying technology that can be utilized for biologics
• Experiences from lab and large-scale spray freeze-drying experiments will be discussed in this talk
 

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14:00

Vial breakage during Lyophilization – Mechanisms and Case studies

Ekneet Sahni, Senior Process Development Scientist, Pfizer

• Why is it hard to translate same breakage rates on laboratory scale from commercial scale
• Elucidating vial breakage mechanisms during lyophilization cycle optimization using strain gauges
• Discuss breakage stress testing of vials
 

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14:40

Continuous Lyophilization of Unit Doses

Bernhardt Trout, Professor of Chemical Engineering, MIT

• New fully continuous approach to lyophilization in vials
• Bench scale data to inform design in a variety of model products
• Substantial savings in time and resources, plus flexibility
 

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15:20

Afternoon Tea

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15:50

Alternative Drying Technologies to Enable Semi-Continuous Manufacturing

Justin Stanbro, Associate Principal Scientist, Merck & Co.

• Review the current state of lyophilization alternatives
• Introduce microwave vacuum drying: fundamentals and advantages
• Discuss compatibility of microwave vacuum drying to sensitive biologics and vaccines
• Explore opportunities to synergize microwave vacuum drying with other new approaches, such as bulk drying and alternative Drug Product images
 

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16:30

Predictive modeling for lyophilization equipment characterization, process scale-up and technology transfer

Ehab Moussa, Senior Scientist, AbbVie, Inc.

• Experimental and computational approaches to characterize lyophilization equipment
• Approaches to measure the product resistance of the formulation
• Considerations for process scale-up and technology transfer
 

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17:10

Chairman’s Closing Remarks and Close of Day One

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8:30

Registration & Coffee

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9:00

Chair's Opening Remarks

Madhushree Gokhale, Principal Scientist, Bristol Myers Squibb

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9:10

Utilizing Raman Spectral Changes to Predict Lyophilized Protein Stability

Lauren Fontana, Principal Scientist , Sanofi

• Development of a Raman spectroscopic method to detect secondary and tertiary structural changes in proteins in solution or solid state
• Application of the Raman method to screen protein formulations for stability rank order due to structural changes during the lyophilization process or storage
• Evaluation of the method benefits, limitations and potential applications for future use
 

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9:50

Quality by Design Approach to Development of a Lyophilized Multidose Vaccine

Sara Yazdi

Sara Yazdi, Senior Scientist, Takeda Vaccines

• Critical process parameters for lyophilized vaccines
• Excipient Impact
• Development of a multidose format
 

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10:30

Morning Coffee

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11:00

Crystallization and other phase transitions during freeze-drying: why we need to understand, and how to monitor

Evgenyi Shalaev, Executive Director, Allergan Plc

• Crystallization is the most common liquid/solid phase transition, while formation of micelles and crystalline mesophases can also take place during freeze-drying
• Crystallization of excipients and/or active ingredients (e.g., PEG in PEGylated proteins) could have a major impact on the yield and stability of freeze-dried products
• Various laboratory-based and PAT-related methods to monitor phase transitions are discussed
 

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11:40

Lyophilization Process Optimization, Tech transfer and Scale-up Challenges for Drug Product Manufacturing

• Lyophilization Process Optimization is critical for improving process efficiency without impacting drug product quality
• Scale-up of lyophilization process from lab or pilot scale lyophilizer to commercial lyophilizer is a major challenge for successful tech transfer
• Various approaches for improving lyophilization process efficiency will be presented. Also, technical considerations for scale-up of freeze drying process will be discussed in this talk
 

Swapnil Pansare, Principle Scientist, Bristol-Myers Squibb Co

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12:20

Networking Lunch

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13:20

A new approach to lyophilization process development and transfer enabled by equipment characterization and process modeling

Fabrice Schlegel, Senior Engineer, Amgen

• Development: Predict a virtual characterization space representative of all equipment scales.
• Scale-up / tech transfer: Leverage process model to drastically reduce number of runs at full scale.
• Manufacturing: Use first principle model as soft sensor to predict product temperature in real time in commercial manufacturing.
 

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14:00

Controlled Ice Nucleation – Investigating the impact of nucleation technique, formulation, and product properties on process performance

Chakradhar Padala, Director, Amgen

• Impact of controlled nucleation on lyophilization cycle times for varying fill volumes & formulation types
• Case study comparing two different controlled nucleation techniques, and their impact on process performance & quality attributes
• Is annealing an alternative to controlled nucleation for process performance?
• Business considerations for technology selection, and implementation at a manufacturing plant
 

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14:40

Afternoon Tea

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15:10

Continuous monitoring of sublimation rate for individual containers in freeze drying processes

Pouya Tavousi, Postdoctoral Fellow, University Of Connecticut

• Negating the need for conventional gravimetric measurements
• Providing more accurate measurements than TDLAS
• Introducing minimal disturbance to the freeze drying process
• Facilitating data acquisition for recipe design
 

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15:50

Formulation Development Strategy to Stabilize Lyophilized Protein Drug Product

Charlie Tang, Director,áFormulationáDevelopment, Regeneron Pharmaceuticals, Inc.

• Understand the requirement of target drug product profile at different stages of product development
• Develop a stable lyophilized formulation to meet initial clinical requirement
• Implement formulation and lyophilization strategies to maximize product stability
• Develop a lyophilized Drug Product for potential room temperature storage
 

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16:30

Chair’s Closing Remarks and Close of Day Two


Project Engineering and Development Leader
OPTIMA pharma GmbH
Professor of Chemical Engineering
MIT
Director
Amgen
Director,áFormulationáDevelopment
Regeneron Pharmaceuticals, Inc.
Senior Scientist
AbbVie, Inc.
Senior Process Development Scientist
Pfizer
Executive Director
Allergan Plc
Senior Engineer
Amgen
Senior Associate Scientist
Pfizer
Associate Principal Scientist
Merck & Co.
Principal Scientist
Sanofi
Principal Scientist
Bristol Myers Squibb
Postdoctoral Fellow
University Of Connecticut
Head Sales Containment
Skan
Senior Scientist
Takeda Vaccines
Principle Scientist
Bristol-Myers Squibb Co
Associate Professor
University of Connecticut

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Sheraton Boston Hotel

39 Dalton Street, Boston, MA, USA

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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USA Lyophilization Preliminary Attendees

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Lyophilization USA 2019 Attendees

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Interview with Timothy McCoy at Sanofi

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Interview with Fabrice Schlegel, Amgen

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2018 Infographic

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Lyophilization USA Previous Attendee List

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Interview with Lauren Fontana from Sanofi

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Challenges of Lyophilized Products Development

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Another View of the Freeze Dryer Design Space -

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Interview - Richard Denk, SKAN AG

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Speaker Interviews 2019

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Vacuum foam drying of biotherapeutics - Alex Langford, Pfizer

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Speaker list 2019

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Lyophilization 2019 Brochure

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Lyophilization USA 2019 Workshop Programme

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Lyophilization 2019 Programme

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Sponsors


Optima

Sponsors
https://www.optima-packaging.com/en-us/pharma/fields-of-application/freeze-drying-systems

Optima Pharma develops and manufactures filling, sealing and process technology for pharmaceutical products. Freeze drying systems and isolator technology are part of turnkey systems by Optima Pharma. The product range includes machinery for laboratory filling up to high-speed systems. Optima Pharma is a member of the OPTIMA packaging group GmbH.

Media Partners


American Pharmaceutical Review

Key Media Partners
http://www.americanpharmaceuticalreview.com

Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy

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Lyophilization World

Supporting Media Partners
https://www.lyophilizationworld.com/

Lyophilization World is a global platform in the field of lyophilization and freeze drying technology. Follow us to be informed in a unique way about current solutions, future trends and news in lyophilization


International Pharmaceutical Industry (IPI)

Supporting Media Partners
http://ipimediaworld.com/

IPI – International Pharmaceutical Industry IPI – was established to fill in the void for effective marketing and communication between all stakeholders in the Life sciences sector globally. Edited by our carefully selected editorial advisory panel, and extensive research network, IPI provides a proven supportive means of communication to the pharmaceutical, bio pharmaceutical, nutraceutical and medical devices industry the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies which will enable them to be more efficient, bring products to market faster, reduce cost and make healthcare accessible to all.

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CanBiotech

Supporters
http://www.canbiotech.com

CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.

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Sheraton Boston Hotel

39 Dalton Street
Boston 02199
USA

Sheraton Boston Hotel

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

HOTEL BOOKING FORM

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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