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NIPTE: INSIGHT INTO THE FUNDAMENTALS OF FREEZE-DRYING / LYOPHILIZATION
November 14th, 2018

This workshop is an abbreviated short course intended for those who are new to the area of freeze-drying/lyophilization. Participants will be provided an understanding of the essential aspects of freeze-drying necessary to better understand the more advanced topics to be presented at the subsequent conference.

View workshop programme on the Download Centre

Workshop Leader:
Robin Bogner, Professor, University of Connecticut

Dr. Bogner is Professor of Pharmaceutics in the Department of Pharmaceutical Science at the University of Connecticut where she is also a member of the Institute of Materials Science and has been involved in the NIPTE since its inception. 

NIPTE is a non-profit academic organization with the mission to improve human health through multi-university collaborative research advancing quality, safety, affordability, and speed to market of medicines.

Participants will learn:

  • The variety of products that are manufactured by freeze drying
  • Details of the major steps in the freeze-drying process
  • Formulation of solutions to be freeze-dried
  • How to approach freeze-drying process design using common process analytical technologies

View workshop programme on the Download Centre

 

Workshop LEADER

keynote-img

Robin Bogner

Professor of Pharmaceutics , University Of Connecticut

Dr. Bogner is Professor of Pharmaceutics in the Department of Pharmaceutical Science at the University of Connecticut where she is also a member of the Institute of Materials Science. She received her B.S. in Pharmacy from Rutgers University, M.S. from the University of Iowa, and Ph.D. from Rutgers University after which she joined the faculty of the University of Connecticut. Dr. Bogner’s research interests are focused on the characterization and dissolution of pharmaceutical solids, both freeze-dried parenterals and oral dosage forms. She teaches a course in mass transfer and in a freeze-drying course at the University of Connecticut. Dr. Bogner has served on several editorial boards, a USP committee, an FDA advisory committee and in various leadership roles in the American Association of Pharmaceutical Scientists (AAPS). Dr. Bogner is a faculty member of the National Institute for Pharmaceutical Technology and Education, a group of faculties from 17 universities with the mission of improving the way medicines are designed, developed and manufactured to meet the needs of patients in the 21st century (https://nipte.org/).She has been involved in the NIPTE since its inception. Dr. Bogner is also a Teaching Fellow at the University of Connecticut, and Fellow of the AAPS.

University Of Connecticut

NIPTE is a non-profit academic organization with the mission to improve human health through multi-university collaborative research advancing quality, safety, affordability, and speed to market of medicines. It is comprised of 17 top schools of pharmacy, chemical and pharmaceutical engineering, and a medical school. Current members are Duquesne University, Illinois Institute of Technology, Long Island University, Purdue University, Rutgers University, Texas A&M University, University of Connecticut, University of Iowa, University of Kansas, University of Kentucky, University of Maryland, University of Michigan, University of Minnesota, University of Puerto Rico, University of Rochester Medical Center, University of Texas, and University of Wisconsin. Web: www.nipte.org.

Workshop programme

13:30 Registration and coffee

14:00 Chairman's Opening Remarks

Robin Bogner

Robin Bogner, Professor of Pharmaceutics , University Of Connecticut
View Bio

14:10 Introduction to freeze drying

Robin Bogner

Robin Bogner, Professor of Pharmaceutics , University Of Connecticut
View Bio

  • Why dry?
  • What we dry- drug substance, intermediates, small molecule therapeutics, protein drugs, complex dosage forms, cells and tissues
  • Freeze-drying containers- vials, trays, dual chamber syringes etc.
  • 14:50 Steps in the freeze drying process

    Robin Bogner

    Robin Bogner, Professor of Pharmaceutics , University Of Connecticut
    View Bio

  • Ice nucleation and changes in ice crystals during freezing
  • Heat and mass transfer for sublimation or ice (or other solvents) during primary drying
  • Maintaining the product temperature below Tg’ or a eutectic temperature
  • The difference between primary drying and secondary drying

     

  • 15:30 Afternoon Tea

    16:00 Formulation and fill

    Robin Bogner

    Robin Bogner, Professor of Pharmaceutics , University Of Connecticut
    View Bio

  • When and what quantity to use for formulation components including lyoprotectants, surfactants, buffers, bulking agents
  • Why fill depth matters
  • Understanding and measuring the Tg’ of the formulation
  • Phase changes in the formulation during freezing and drying
  • 16:40 Process design and process analytical technologies

    Robin Bogner

    Robin Bogner, Professor of Pharmaceutics , University Of Connecticut
    View Bio

  • Design space and batch uniformity
  • When is the product dry?
  • Real time measures of sublimation rate
  • Real time measures of product temperature
  • 17:20 Closing Remarks and End of Workshop

    Robin Bogner

    Robin Bogner, Professor of Pharmaceutics , University Of Connecticut
    View Bio

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    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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    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’

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

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    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.

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    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.

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