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SMi Group’s 2nd Annual Lyophilisation USA conference returns to the USA on April 27-28 in 2016.

The thriving biopharmaceutical industry and rise in contract services are driving lyophilization in an exponential rate. In addition, the rise of combination products and innovative drug delivery devices enable innovative drug formulations which can only be stable in solid format. As a result, the global lyophilization market is estimated to grow from a value of US $2.bn in 2013 to US$4.8 bn by 2020.*

While companies are still dedicating research efforts on drying technologies, commerciality of scaling up and homogeneity of product quality remain top concerns amongst pharmaceutical companies.

The SMi 2nd annual Lyophilization USA conference returns to New Jersey in 2016 to go one step further, exploring and assessing how QbD can accelerate drug development and lyophilization programme, industrialization and scale-up for economic cycle, as well as overcoming regulatory uncertainties.

Join us today to gain practical insights for optimal commercialization of your lyophilization program for a replenished drug pipeline!

http://prn.to/1VncY5L

Why You Should Join Us Today:

• Define CQAs and QbD for a smooth lyophilization program – bridging upstream and downstream
• Learn about new technologies to accelerate lyophilization process and stabilize complex biologics products
• Thrive on product quality control and assurance during mass production and tech transfer
• ‘Dry fast and smart’ – develop a commercially viable lyophilization cycle
• Benchmark your strategies against peers’ and industy experts’ to ensure a sustainable drug development program and pipeline
 

Sneak Peek of 2016 Program:

J&J presents why lyophilization is no longer just a downstream process
• Understand protein stability and its changes during freezing and drying
Novo Nordisk assesses aseptic spray drying as an alternative to lyophilization
Genzyme shares their thoughts on commercial competitiveness of lyophilized products
Biogen Idec discusses the optimal approach of lyophilization scale-up
 

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

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

from pharmaceutical, biotech, device and technology providers.

AbbVie Ltd; Arlenda; Baxter AG; Baxter Pharmaceutical Solutions, LLC; BioPharma Technology; BMS; Boehringer Ingelheim; CTG GMP; DSM Pharmaceuticals Inc; Ellab Inc; EnWave Corporation; Explicat Pharma GmbH; Genentech, Inc.; Genocea Biosciences; Idexx Laboratories Inc; IMA Life North America Inc.; ImmuCell Corporation; iQ-Mobil; KBI Biopharma; Labconco Corp; Lyophilization Technology, Inc; Medimmune Inc; Merck; Merck & Co Inc; Merck & Co.; Merck & Co., Inc.; Merck Research Laboratories; Millrock Technology, Inc.; Momenta Pharmaceuticals Inc; NNE Pharmaplan; Novo Nordisk A / S; One 2 One Hospira; Patheon Manufacturing Services; Pfanstiehl, Inc.; Roche; Sandoz GmbH; Sanofi Pasteur; Seahorse Bioscience; Shire Pharmaceuticals; SP Scientific; University Of Geneva; West Pharmaceutical Services; Xstalbio Ltd;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Jim Searles

Jim Searles, Technical Fellow, Global Technical Services, Pfizer Inc.

Sune Andersen

Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S

9:10 Effect of Pressure and Dryer Load upon Secondary Drying Rates

Jim Searles

Jim Searles, Technical Fellow, Global Technical Services, Pfizer Inc.

  • Fundamentals of the secondary drying phase
  • Effects of process parameters such as temperature and pressure
  • In-depth focus upon dryer load and pitfalls of scale-up
  • 9:50 QbD Principles – How Can This Help with Topical Dosage Formula?

    Naveen Kanthamneni

    Naveen Kanthamneni, Formulation Scientist, R&D Development, Endo Pharmaceuticals Inc.
    View Bio

    10:30 Morning Coffee

    11:00 Load Them Properly: Lessons Learnt from the Condenser Coil Temperature Alarms

    Vineet Kumar

    Vineet Kumar, Senior Scientist, Johnson And Johnson

  • Impact of condenser performance on quality
  • Design of lyophilizer, doors and alarm probes
  • Filling time and humidity considerations on loading temperatures
  • 11:40 Protein Stability: Change in the Apparent Acidity During Freezing and Drying

    Ke Wu

    Ke Wu, Senior Scientist, Allergan

  • Stability concerns over lyophilized-products
  • Excipients to enhance stability and shelf-life
  • Interaction with APIs
  • Search for the optimal pH for lyopilization

     

  • 12:20 Networking Lunch

    13:20 ControLyoTM Nucleation on Demand: The Impact of Controlling Nucleation on Finished Material Attributes and Processing Characteristics for Bulk Material and Vialed Product

    Dr. Karen Bossert

    Dr. Karen Bossert, Vice President, Scientific Affairs, Lyophilization Technology, Inc

  • ControLyoTM technology offers improvement in uniformity of ice nucleation within a batch
  • Are improvements truly seen in processing characteristics and finished product attributes?
  • Data presented include bulk systems and model drug products, encompassing model crystalline and amorphous materials
  • 14:00 Residual Water Content in a Lyophilized Drug Product – Optimizing Secondary Drying

    Lisa Hardwick

    Lisa Hardwick, Research Scientist, Baxter BioPharma Solutions

  • How dry should it be? Determining ideal water content for drug products
  • How to customize your drying process?
  • Analytical methods to best analyze effect of residual water on stability
  • 14:40 Afternoon Tea & Networking Break

    15:50 Aseptic Spray Drying as an Alternative to Lyophilization?

    Sune Andersen

    Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S

  • Recent breakthroughs in aseptic spray drying technologies for commercial production
  • Approaches for aseptic powder filling
  • Comparison of aseptic drying processes
  • 16:30 Panel Discussion: Is Lyophilization the Way to Go Forward?

    Padam Sharma

    Padam Sharma, Sterile Drug Products, Injectables, External Contract Manufacturing, Aseptic Processing, Allergan Inc

  • Exploring current market trends for pharmaceutical products and needs for lyophilization
  • Marrying sciences with commerciality – scalability and product quality
  • Exploring the alternatives to lyophilization
  • 17:10 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Jim Searles

    Jim Searles, Technical Fellow, Global Technical Services, Pfizer Inc.

    Sune Andersen

    Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S

    9:10 Commercial Competitiveness of Lyophilized Products

    Mark Yang

    Mark Yang, Director, Genzyme

  • Lyophilization is often unavoidable for biologics and is a growing market
  • Strategies to reduce lyophilization cycle and cost for commercial manufacturing
  • New technologies that can shorten lyophilization development time and improve its efficiency
  • Dried but not lyophilized? Technologies beyond lyophilization
  • 9:50 Clearing the Fog: Characterization of the Fogged Layer in Lyophilized Products and Studies with Hydrophobic-Coated Vials

    Chris Heynes

    Chris Heynes, Senior Engineer, Genentech

  • Characterization of 'fog' product layer observed in vials and benefits of a hydrophobic coating
  • Processing studies supporting implementation of hydrophobic-coated vials in manufacturing
  • Product stability studies with hydrophobic-coated vials
  • 10:30 Morning Coffee

    11:00 Accurate and Reliable Determination of Collapse Temperature by Optical Coherence Tomography-Freeze Drying Microscope (OCT-FDM)

    Vamsi Mudhivarthi

    Vamsi Mudhivarthi, Postdoctoral Fellow, University Of Connecticut

  • Accurate and reliable determination of maximum allowed product temperature during primary drying
  • Higher collapse temperature determined by OCT-FDM, which is representative of the collapse temperature for product drying in commercial containers
  • Design of efficient primary drying process  
  • 11:40 Freeze Dried Medical Device Products

    Mrinal Shah

    Mrinal Shah, Senior Engineer, Process Development, LifeCell Corporation

  • Biologics in the medical device world
  • Human and animal derived tissue extracellular matrix scaffold products
  • Features, properties and characterizing the same
  • 12:20 Networking Lunch

    13:20 Looking at Lyophilization from ICH Q8(R2) Perspective

    Ravi S. Harapanhalli

    Ravi S. Harapanhalli, Principal, FDAPharma Consulting

    ICH Q8 (R2) emphasizes a systematic approach to the design of a drug product and the corresponding process that can consistently deliver a drug product of pre-defined quality target product profile. This presentation focuses on how ICH Q8 (R2) can be applied in the development and optimization of lyophilization processes and what kind of information may be included in a pharmaceutical development section of an NDA or BLA.

  • Basic QbD information needed in regulatory submissions
  • Enhanced QbD information including design space that may be submitted
  • Application of ICH Q9 - quality risk assessment to lyophilization processes
  • Lyophilization process understanding
  • 14:00 Freeze Thaw for Protein Stabilization

    Jamie Tsung

    Jamie Tsung, Principal Scientist, Momenta Pharmaceuticals Inc

  • How to store and what temperature range is optimal?
  • Freeze thaw process – will this impact on drug quality and efficacy?
  • Product stability during storage – eliminating crystallization and extending shelf-life
  • 14:40 Afternoon Tea & Networking Break

    15:10 Application of Statistics across the Lyo Product Lifecycle

    Perceval Sondag

    Perceval Sondag, Senior Statistician, Arlenda

  • Statistics for Quality-by-Design (QbD)
  • Optimal sampling and capability prediction for process performance qualification (PPQ)
  • Predicting performance from the bioreactor to the patient
  • 15:50 Panel Discussion: Quality Assessment for Lyophilized Products

  • Quality is key - developing stable and GMP-compliant lyophilized products

  • From formulation to manufacturing - what are the key concerns and risks?

  • Tech transfer: How to implement across various plants?

  • Sune Andersen

    Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S

    Padam Sharma

    Padam Sharma, Sterile Drug Products, Injectables, External Contract Manufacturing, Aseptic Processing, Allergan Inc

    16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Dr. Karen Bossert

    Dr. Karen Bossert

    Vice President, Scientific Affairs, Lyophilization Technology, Inc
    Jim Searles

    Jim Searles

    Technical Fellow, Global Technical Services, Pfizer Inc.
    Ke Wu

    Ke Wu

    Senior Scientist, Allergan
    Mark Yang

    Mark Yang

    Director, Genzyme
    Padam Sharma

    Padam Sharma

    Sterile Drug Products, Injectables, External Contract Manufacturing, Aseptic Processing, Allergan Inc

    Chris Heynes

    Senior Engineer, Genentech
    Chris Heynes

    Dr. Karen Bossert

    Vice President, Scientific Affairs, Lyophilization Technology, Inc
    Dr. Karen Bossert

    Jamie Tsung

    Principal Scientist, Momenta Pharmaceuticals Inc
    Jamie Tsung

    Jeff Schwegman

    Founder & CEO, AB BioTechnologies
    Jeff Schwegman

    Jim Searles

    Technical Fellow, Global Technical Services, Pfizer Inc.
    Jim Searles

    Ke Wu

    Senior Scientist, Allergan
    Ke Wu

    Lisa Hardwick

    Research Scientist, Baxter BioPharma Solutions
    Lisa Hardwick

    Mark Yang

    Director, Genzyme
    Mark Yang

    Mrinal Shah

    Senior Engineer, Process Development, LifeCell Corporation
    Mrinal Shah

    Naveen Kanthamneni

    Formulation Scientist, R&D Development, Endo Pharmaceuticals Inc.
    Naveen Kanthamneni

    Dr. Naveen Kanthamneni is currently working as a Formulation Scientist at Par Pharmaceuticals - An Endo International Company. He was honored with a PhD in Pharmaceutical Sciences from The Ohio State University and MS from Western University of Health Sciences. His areas of expertise are formulation of different dosage forms varying from solids (IR/MR) to semi solids (creams, ointments, gels). He is also currently serving as an editorial member for acclaimed journals. Dr. Naveen has published several research articles in peer reviewed journals and presented at various international conferences like AAPS, CRS, AACR, etc.

    Padam Sharma

    Sterile Drug Products, Injectables, External Contract Manufacturing, Aseptic Processing, Allergan Inc
    Padam Sharma

    Perceval Sondag

    Senior Statistician, Arlenda
    Perceval Sondag

    Ralph Tarantino

    Pharmaceutical Consultant & Principal, Steritech Solutions, LLC
    Ralph Tarantino

    Ravi S. Harapanhalli

    Principal, FDAPharma Consulting
    Ravi S. Harapanhalli

    Sune Andersen

    Principal Scientist Drying Processes, Novo Nordisk A / S
    Sune Andersen

    Vamsi Mudhivarthi

    Postdoctoral Fellow, University Of Connecticut
    Vamsi Mudhivarthi

    Vineet Kumar

    Senior Scientist, Johnson And Johnson
    Vineet Kumar

    Sponsors and Exhibitors

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    Official Publication

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    Workshops

    Lyophilization – Development through Tech Transfer
    Workshop

    Lyophilization – Development through Tech Transfer

    Renaissance Woodbridge Hotel
    29th April 2016
    Iselin, USA

    Arrive Early to Attend Pre-Filled Syringes East Coast

    Download

    Lyophilisation Europe

    Download

    60 Second Quick Fire Q&A with Baxter Healthcare Corporation

    Download

    An Interview with One2One

    Download

    Lyophilization USA List of Previous Attendees

    Download

    Sponsors and Exhibitors


    Emergent BioSolutions

    Sponsors and Exhibitors
    http://www.emergentcontractmanufacturing.com

    Emergent BioSolutions provides contract manufacturing services for both bulk drug substances and finished drug products. Emergent’s Fill/Finish service offering includes vials and syringes, for both liquid and lyophilized products (including lyo cycle development). Emergent’s manufacturing facilities currently produce 20 commercial products and supported over 200 clinical drug products.


    Kamat Pharmatech

    Sponsors and Exhibitors
    http://www.kamatpharma.com

    Kamat Pharmatech provides expertise in the development, manufacture, and regulatory filing of various injectable dosage forms, especially lyophilized products, emulsions, and micro/nano-suspensions. With over 27 years of experience in successfully developing more than 15 commercial lyophilized products, Kamat Pharmatech offer comprehensive and practical assistance in all aspects of development of lyophilized products and processes.


    MILLROCK TECHNOLOGY

    Sponsors and Exhibitors
    http://www.millrocktech.com

    Millrock Technology is a leader in the innovation, design and manufacturing of freeze drying / lyophilization solutions. Since the 1950s, the Millrock team has been solely focused on advancing the science of freeze drying / lyophilization for the pharmaceutical, biotech and related industries, working in partnership with our customers to innovate products that deliver performance and optimize their processes.


    Pfizer CentreOne

    Sponsors and Exhibitors
    http://www.pfizercentreone.com

    Introducing Pfizer CentreOne. We're combining the best of Pfizer CentreSource and Hospira One 2 One to form one global CMO. New name, expanded capabilities, same focus: YOU. Pfizer CentreOne is a global contract manufacturer that focuses on API synthesis and sterile injectables fill-finish. Learn more at www.pfizercentreone.com


    SP Scientific

    Sponsors and Exhibitors
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    SP Scientific, leaders in ControLyo™ Nucleation Technology, is comprised of highly regarded scientific equipment brands —Hull, VirTis, FTS Systems, Genevac and Hotpack — creating one of the largest and most experienced companies in freeze drying/lyophilization, environmental rooms and chambers, centrifugal evaporation and concentration, temperature control, and glassware washers. More than a manufacturer, SP Scientific assists customers in matching equipment to particular application needs.

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    ONdrugDelivery Magazine is the highly regarded, world-leading series of sponsored themed drug delivery publications. Uniquely, each issue focuses tightly on one topic within the field of drug delivery. With a truly global readership already in excess of 40,000, and with contributions and loyal support from many of the most important companies in the drug delivery business - from among the largest to the smallest - ONdrugDelivery Magazine is a must for those in the industry who need to know what's going on in drug delivery.


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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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    IJBET addresses cutting-edge research in the multi-disciplinary area of biomedical engineering and technology. Medical science incorporates scientific/technological advances combining to produce more accurate diagnoses, effective treatments with fewer side effects, and improved ability to prevent disease and provide superior-quality healthcare. A key field here is biomedical engineering/technology, offering a synthesis of physical, chemical, mathematical and computational sciences combined with engineering principles to enhance R&D in biology, medicine, behaviour, and health. IJBET includes the Asia-Pacific Chapter in Biomedical Wireless Technology (APC-BWT).

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    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830
    USA

    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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    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, SMI 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@smi-online.co.uk

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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




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