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SAE Media Group announces the return of its 3rd annual Lyophilization USA Conference to New Jersey on November the 16th- 17th November 2017

As biopharmaceuticals continue to dominate the market the need for greater shelf life and protein stability has increased. For many biological products lyophilization is a necessity and the technology is constantly advancing. As manufacturing demands increase the global lyophilization market for pharmaceutical and biotechnology products is expected to reach $2.66 billion by 2019* and this a trend that is likely to continue as we push the boundaries of biopharmaceutical formulation and transport. (Source: *http://bit.ly/2fkSDos)

One of the main challenges in pharmaceutical lyophilization continues to be the scale- up and the implementation of QbD protocols for the optimization of cycles. Several companies are researching and developing ways to facilitate commercial bulk lyophilisation of vaccines, protein and cells while also reducing costs.

Join us as we look at advances in lyophilizing technology, PAT tools, QbD and design space, strategies to enhance lyophilization formulation and innovative alternative to Lyophilization

We Are One of A Kind...

Networking: We keep networking at the forefront when it comes to our attendees. Expand your community with every part of the industry and with the right people to benefit your company and develop your career.

The Agenda: Be sure to have your pen and pad ready at all times! A valuable time is spent to discover the latest trends and hottest topics in the industry to provide the best possible agenda for our attendees.

Location/Venue: Being held in beautiful New Jersey, The Renaissance Woodbridge Hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for business travelers alike. Explore New Jersey by visiting iconic places, why not take a stroll on Atlantic City and The Boardwalk - one of the most popular coastal resort towns of the US. Or even see some history such as the Old Victorian Cape May and Thomas Edison National Historical Park.

Onsite: Our knowledgeable events team will provide you with an exceptional service onsite. They will answer any questions you may have and inform you about any changes to the agenda.

The Conference:

  • Real life case studies and developments in scale up and technology transfer.
  • New approaches to process understanding of using novel PAT approaches and QbD principles.
  • Tackle challenges in freeze-drying high concentration biologics.
  • Explore strategies in technology transfer and scale up for lyophilized products.
  • Discuss vapour pressure monitoring and controlled nucleation.
  • Gain an exciting insight into bulk lyophilization and automation.

Key Job Titles:

VPs, Directors, Chiefs, Heads, Principals, Managers and Analysts of:

  • Freeze-drying/ Lyophilisation
  • Formulation Scientist
  • Bioprocessing
  • Process Development
  • Sterile/ Fill-Finish
  • Production
  • PAT
  • CMC
  • Chemistry
  • Manufacturing
  • Quality Assurance/QA

Global Presence:

Attendees from all over the world attend our events, gain hands on insight from representatives from USA, UK and Europe.

Companies Include:

AbbVie | Allergan | Arlenda | Baxter BioPharma Solutions | Bristol-Myers Squibb | Cerulean Pharma | Emergent BioSolutions | Endo Pharmaceuticals | FDAPharma Consulting | Fresenius Kabi Austria GmbH | Fresenius Medical Care North America (FMCNA) | Genentech | Genzyme | GSK | IDT Biologika | ImmuCell Corporation | Jamjoom Pharma | Johnson And Johnson | Kamat Pharmatech | Kashiv Pharma |  KBI Biopharma | LifeCell Corporation | Lyophilization Technology | Merck & Co. | Millrock Technology | Momenta Pharmaceuticals | Novo Nordisk | OPTIMA Pharma GmbH | Patheon Manufacturing Services | Pfizer | SP Scientific | Steritech Solutions | SurModics | W.L. Gore & Associates

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Andrea  Weiland-Waibel

Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH

9:10 Hydrogen Deuterium Exchange Mass Spectrometry for formulation/process optimization in lyophilized solids

Lokesh  Kumar

Lokesh Kumar, Associate Scientist, Genentech

  •  Basics of hydrogen deuterium exchange Mass Spectrometry (HDX-MS), for formulation and process optimization, will be briefly discussed
  • Impact of formulation parameters, i.e., protein: sucrose ratio, type of stabilizer etc. will be discussed
  • Impact of processing parameters, including controlled ice nucleation and annealing, on stress stability will be discussed. Correlation of HDX-MS data with stress stability would be performed to evaluate rank ordering of the impact of processing conditions
  • 9:50 Lyophilization process development, scale-up and technology transfer strategies

    Charlie Tang

    Charlie Tang, Director, Formulation Development, Regeneron Pharmaceuticals

  • Traditional approaches for process design, scale-up, and tech transfer
  • Impact of lyophilizer design on lyophilization process transfer and scale up
  • Challenges that can occur when implementing plans for large scale lyophilization
  • 10:30 Morning Coffee

    11:00 Holistic approach to packaging and innovative design

    Guido  Schmitz

    Guido Schmitz, Head of Packaging & Technology Innovation, Bayer Consumer Care

  • Case study on innovation in packaging of pharmaceuticals
  • challenges designing packaging that ensures patient safety and meets regulatory requirements
  • Relating consumer- friendly packaging to lyophilized products
  • 11:40 Tempris – how wireless product temperature monitoring is used in commercial lyophilization today

    Anton Mangold

    Anton Mangold, Managing Director, iQ-Mobil

  • Characterization and qualification of FDs
  • Determination of critical positions
  • Temperature data to evaluate the robustness of Lyo processes
  • 12:20 Networking Lunch

    13:30 Mathematical and experimental modelling for development and scale-up of lyophilisation cycles

    Pavol  Rajniak

    Pavol Rajniak, Principal Consultant, PROCESS SYSTEMS ENTERPRISE LIMITED

  • Inhomogeneous lyophilisation as a key challenge for development and scale-up of lyophilisation cycles
  • Development and calibration of mathematical models of different complexity by fitting to freeze-drying experimental data
  • Case Study 1 – a workflow for development and scale-up using a single vial approach
  • Case Study 2 – experimental and theoretical study of lyophilisation from a packing of vials
  • 14:10 Assessing phase separation in lyophilized protein formulation

    Kelly  Forney Stevens

    Kelly Forney Stevens, Drug Product Development , GSK

  • Understanding how and when phase separation occurs
  • Methods utilized to detect phase separation
  • Impact of formulation components and process parameters on phase separation
  • Significance of phase separation in lyophilized formulations
  • 14:50 Afternoon Tea

    15:20 Formulation strategies during clinical development

    Katherine  Bowers

    Katherine Bowers, Scientist II, Fujifilm Diosynth Biotechnologies

  • The biophysical tools required to understand a protein biopharmaceutical
  • Formulation design with uncertain dosage/delivery formats
  • Transitioning from frozen or liquid to lyophilized formulations
  • 16:00 Impact of controlled nucleation on physico-chemical properties and stability of lyophilized biologics

    Stefan  Heindl

    Stefan Heindl, Business Development Manager, Coriolis Pharma

  • Overview and comparison of different approaches for controlled nucleation
  • Application of controlled nucleation for low and high concentration protein formulations
  • Impact of controlled nucleation on physico-chemical properties of lyophilized biologics
  • Impact of controlled nucleation on protein stability
  • 16:40 Chair’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Andrea  Weiland-Waibel

    Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH

    9:10 Process validation for lyophilized drug products: Developing a program for continued process verification

    Karen  Bossert

    Karen Bossert, President, KB Consulting

  • Explore a series of classical approaches to data treatment to apply throughout all parts of the lyophilization process
  • What are the techniques used to evaluate product and process data from multiple batches of lyophilized drug product?
  • Presentation of data sets and case studies, of multi-batch monitoring
  • Understanding the Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPS) for lyophilized drug products
  • 9:50 Tech transfer & scale-up challenges and considerations for lyophilized products

    Adam   Viverette

    Adam Viverette, Associate Director, Manufacturing, Science and Technology, Melinta Therapeutics Inc

  • Common challenges faced when executing a tech transfer & scale-up project
  • Considerations for a successful tech transfer & scale-up project
  • Integrating process, product & lyophilizer equipment
  • Case studies

     Session reserved

  • 10:30 Morning Coffee

    11:00 Optimization of primary drying cycles using mathematical modelling

    Melissa  Lash

    Melissa Lash, Scientist, Drug Product Development, Johnson And Johnson

  • Influence of annealing on resistance and primary drying for IGG molecules
  • Assessing the variables depending on product properties
  • Modelling Lyophilization processes to develop optimized cycles and scale-up strategies
  • 11:40 Lyocycle development and PAT based optimization

    Andrea  Weiland-Waibel

    Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH

    A case study including modern lyo cycle process performance qualification leading to a PAT real time feedback system controlled lyo cycle for continued process verification

  • Analysis of critical quality attributes of a freeze-dried product
  • Related critical process and product parameters – The product temperature
  • Lyo robustness testing to establish process boundaries and the lyo cycle design space
  • Modern lyo process validation and the implementation into regulatory Lyophilization


  • 12:20 Networking Lunch

    13:30 Stability of sugar-protein lyophilized formulations: Evaluation of phase separation and mobility

    Eric Munson

    Eric Munson, Patrick Deluca Endowed Professor of Pharmaceutical Technology, University of Kentucky

  • Basics of solid-state NMR spectroscopy as a technique for evaluating phase separation and mobility in sugar-protein formulations
  • Impact of sugar crystallization, relaxation times, and phase separation on protein stability will be discussed
  • Comparison of micro-environmental protonation states using solid-state NMR spectroscopy and visible probes will be shown
  • 14:10 Combined empirical and statistical approach to screen lead excipient combinations for lyophilisation of live attenuated tetravalent dengue vaccine

    Sushma Kommareddy

    Sushma Kommareddy, Associate Director Formulation Development, Takeda

  • The talk will focus on a combination experimental approaches utilizing semi-empirical excipient screening
  • Statistical modeling using design of experiments (DOE)
  • Identify stabilizing candidate formulations for a lyophilized live attenuated Flavivirus vaccine candidate
  • 14:50 Afternoon Tea

    15:20 PANEL DISCUSSION: Batch process vs Continuous Process

  • What are the challenges with continuous freeze drying and how to overcome these
  • Methodology to reduce the processing time of the fundamental steps
  • Areas in need of innovation with regards to lyophilization
  • Eric Munson

    Eric Munson, Patrick Deluca Endowed Professor of Pharmaceutical Technology, University of Kentucky

    Jean-Francois Michiels

    Jean-Francois Michiels, Senior statistician, Arlenda

    16:00 Design of Experiment to optimize freeze drying process with a small budget

    Jean-Francois Michiels

    Jean-Francois Michiels, Senior statistician, Arlenda

  • Introduction/Context of lyophilization optimization
  • Screening design
  • Augmented design
  • Process optimization
  • 16:40 Chair’s Closing Remarks and Close of Day Two



    Anton Mangold

    Anton Mangold

    Managing Director, iQ-Mobil
    Charlie Tang

    Charlie Tang

    Director, Formulation Development, Regeneron Pharmaceuticals
    Eric Munson

    Eric Munson

    Patrick Deluca Endowed Professor of Pharmaceutical Technology, University of Kentucky
    Kelly  Forney Stevens

    Kelly Forney Stevens

    Drug Product Development , GSK
    Lokesh  Kumar

    Lokesh Kumar

    Associate Scientist, Genentech

    Adam Viverette

    Associate Director, Manufacturing, Science and Technology, Melinta Therapeutics Inc
    Adam   Viverette

    Andrea Weiland-Waibel

    Managing Director, Explicat Pharma GmbH
    Andrea  Weiland-Waibel

    Anton Mangold

    Managing Director, iQ-Mobil
    Anton Mangold

    Charlie Tang

    Director, Formulation Development, Regeneron Pharmaceuticals
    Charlie Tang

    Eric Munson

    Patrick Deluca Endowed Professor of Pharmaceutical Technology, University of Kentucky
    Eric Munson

    Guido Schmitz

    Head of Packaging & Technology Innovation, Bayer Consumer Care
    Guido  Schmitz

    Jean-Francois Michiels

    Senior statistician, Arlenda
    Jean-Francois Michiels

    Karen Bossert

    President, KB Consulting
    Karen  Bossert

    Katherine Bowers

    Scientist II, Fujifilm Diosynth Biotechnologies
    Katherine  Bowers

    Kelly Forney Stevens

    Drug Product Development , GSK
    Kelly  Forney Stevens

    Lokesh Kumar

    Associate Scientist, Genentech
    Lokesh  Kumar

    Melissa Lash

    Scientist, Drug Product Development, Johnson And Johnson
    Melissa  Lash

    Pavol Rajniak

    Pavol  Rajniak

    Stefan Heindl

    Business Development Manager, Coriolis Pharma
    Stefan  Heindl

    Sushma Kommareddy

    Associate Director Formulation Development, Takeda
    Sushma Kommareddy

    Sponsors and Exhibitors

    Official Media Partner

    Official Online Media Partners



    Introduction to Design of Experiments

    Introduction to Design of Experiments

    Renaissance Woodbridge Hotel
    15th November 2017
    Iselin, USA



    [SPONSOR CONTENT] - SCHOTT_iQPlatformCPhI2017_US_final


    Lyophilization USA 2016 Attendee List


    [SPEAKER INTERVIEW] Kelly Forney Stevens, Drug Product Development, GSK Vaccines


    Sponsors and Exhibitors


    Sponsors and Exhibitors

    Ellab is an industry leading manufacturer of wireless dataloggers and wired thermocouple validation systems used in the pharmaceutical industry. Outside of temperature sensors Ellab offers vacuum, pressure, CO2, and RH sensors. Specifically, for the lyophilization process, Ellab specializes in analyzing shelf and product temperatures within a full lyophilization cycle.

    Process Systems Enterprise

    Sponsors and Exhibitors

    PSE’s mechanistic modelling solutions result in more efficient R&D and more effective experiments, more rapid formulation screening, improved process and product designs, reduced scale-up and tech transfer risk, better capture and transfer of knowledge across the organisation. In addition to lyophilisation, PSE has solutions for synthesis, crystallization, milling, spray drying, granulation, in-vitro dissolution and in-vivo absorption. PSE is pioneering the emerging science of Systems-based Pharmaceutics with Eli Lilly, Pfizer, GSK and Roche, and is the leader of the £20.4m digital design ADDoPT project.

    SCHOTT North America, Inc. – Pharmaceutical Packaging

    Sponsors and Exhibitors

    SCHOTT is a world leading supplier of parenteral packaging servicing the pharmaceutical, biotech, biopharmaceutical, diagnostic, analytical, dental & ophthalmic markets. Products include glass and polymer prefillable syringes (bulk and sterile), cartridges, ampoules, vials, and innovative coated containers. Ready-to-use solutions are available to meet existing and new fill & finish equipment.


    Sponsors and Exhibitors

    iQ-mobil is the developer and manufacturer of the wireless and battery-free temperature measurement system Tempris. Tempris is used for real-time product temperature monitoring and controlling during lyophilization in order to optimize processes and make pharmaceutical production more cost-efficient. Tempris is a PAT-tool and available for all types of freeze dryers according to cGMP guidelines.

    W.L. Gore & Associates, Inc

    Sponsors and Exhibitors

    Gore & Associates: Almost twenty years ago, Gore introduced what would be the first in the line of exciting innovations for pharmaceutical and biopharmaceutical customers—the GORE® LYOGUARD® Freeze-Drying Tray. Since then, we’ve developed many single- and multi-use products and process components—all with the express focus on improving the customer experience by applying our materials technology and engineering know-how to deliver step-change performance.

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    ONdrugDelivery Magazine

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    American Pharmaceutical Review

    Official Media Partner

    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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    As champions for life science in our state, Colorado BioScience Association leads expansion policies to advance the industry and accelerate growth. We support a thriving bioscience sector by connecting innovators to funding, infrastructure, research and talent. CBSA fosters bioscience workforce and leadership development through opportunities for networking and professional education.

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    Official Media Partner

    Drug Development & Delivery is a print/online content provider that presents the latest scientific methods in drug development for professionals.

    Media Partners


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    The dedicated Audio Visual file sharing platform for the Pharmaceutical, Life Sciences and The Animal Health Industry. Use the power of Audio and Visual to give a clearer information to your clients. www.pharmaworld.tv

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    Drug Discovery Today


    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.



    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.

    Inderscience Publishers


    Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.



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    Medicaldevice-network.com is your one stop for information on the medical device industry, covering everything along the supply chain from biomaterials and materials solutions to electronics, packaging, motors and motion control, outsourcing and more. Through our international team of journalists, we cover diagnosis, prevention, monitoring, standards, treatment and technology – all you need as a professional in the medical industry to stay abreast of the latest developments in your field.



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    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.

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    American Laboratory


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    Journal for Clinical Studies – Your Resource for Multisite Studies & Emerging Markets


    Published bi-monthly.JCS is a unique journal, dedicated to providing information to the global pharmaceutical, biotechnology, medical devices and contract research organisations. JCS details practical and theoretical operational procedures, challenges, validatory and regulatory guidelines when conducting trials on a multisite basis and particularly within the emerging markets, naïve patient population, and remote access areas. JCS provides country by country objectives and uniquely brings you experiences in therapeutic areas of Liver diseases, kidney diseases, insect borne diseases, malnutrition and under nutrition. JCS is led by a strong editorial advisory board sourced out for their experiences; you will get the most practical insight for your global studies. JCS invites you to join us, write for us, feature your experiences with us, advertise your capabilities with us, and ask our advisory board for suggestions and guidelines. Let us make health care available to all.



    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.



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    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830

    Renaissance Woodbridge Hotel

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.



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    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.


    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.


    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.


    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.

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    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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