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2019 ParPack

Interest Group Meeting Packaging Science

Mar 21, 2019
Venice, Italy

CCI at Deep Cold Temperatures

  • Interest Group
  • Europe
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Program Highlights

2019 Focus Topic: CCI at Deep Cold Temperatures

Take advantage of the open forum design offered by the small Interest Group meeting approach. Hear presentations from renowned international experts, interact and discuss your experiences with colleagues in round table discussions and forums during the meeting.
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Overview

Dear Colleagues,

Based on feedback from industry and the many open questions, our focus topic for 2019 will be CCI at deep cold temperature.

Please be invited to contribute to this open forum and discuss latest approaches, exchange experience, and share technology updates on primary packaging challenges related to:

  • Cell and Gene Therapy Market
  • CAR-T Therapy
  • Regulatory challenges for CCI at cold temperatures
  • Challenges for different materials at cold temperatures
  • Measurement techniques

We will have experts to the mentioned topics and would like to highlight this topic from many different angles

Join in on the discussion on 21 March 2019. We look forward to welcoming you to Venice!

Best Regards,

Bettine Boltres, PhD WEST
Derek Duncan, PhD LIGHTHOUSE
Roger Asselta, Genesis Packaging

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Agenda

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  • Thursday, 21 March 2019

    10:00
    Welcome: Opening Remarks & Introductions
    Bettine Boltres, WEST
    Roger Asselta, Genesis Packaging
    Derek Duncan, LIGHTHOUSE

    10:10 – 10:40
    Cell & Gene Therapy – Production, Storage and Transport: Current Challenges and Solutionss
    Richard Zajicek, GSK

    10:40 – 11:00
    Introduction to the Chemical and Physical Properties of Different Packaging Materials
    Bettine Boltres, WEST
    Otto Schubert, Rommelag

    11:10 - 13:30
    Packaging Solutions for Cell & Gene Therapiess
    Moderator: : Derek Duncan, LIGHTHOUSE

    One of the areas in which there is a push for new packaging options is in the area of cell and gene therapies. These products require deep cold storage ranging from -80 ˚C to cryogenict temperatures. Initial studies have shown that these low temperatures pose challenges to the traditional package for injectables—the rubber-stoppered glass vial. This can introduce some risk to container closure integrity. Current solutions and the future outlook will be discussed in this session.

    11:10
    An Introduction of the International Society of Cell and Gene Therapies – A Current Update
    Jean-Sebastien Parisse, Aseptic Technologies

    11:30
    Polymer Container System for Storage of Cell Therapy Products at Cryogenic Temperature
    Nicolas Brandes, WEST

    11:50 – 12:20
    Coffee Break, Poster Session & Exhibition

    12:20
    Packaging solutions, how do materials react in deep cold temperature
    Jean-Sebastien Parisse, Aseptic Technologies
    Robert Sassa, WL Gore

    12:45
    Group Discussion - Challenges in Packaging:

    • What requirements need to be met when packaging and storing cell and gene therapeutics?
    • What solutions are currently available and how do different container react in deep cold temperatures?
    • Which challenges still need to be overcome?

    13:30 – 14:30
    Lunch Break, Poster Session & Exhibition

    14:30 – 17:00
    Materials and their Requirements for Deep Cold Storage
    Moderator: Bettine Boltres, WEST

    In order to understand why and how different materials behave differently under different temperature conditions, the session will start with an in-depth dive into the relevant physical and chemical properties of glass, rubber and plastics. Further on we will get inside information from industry into the challenges that they are facing. We will discuss different approaches and especially identify those areas that still need to be addressed.

    14:30
    Vial Solutions: Challenges for Glass and Stoppers in Deep Cold Temperatures
    Chris Folta, Janssen & Janssen

    14:50
    Container Closure Systems at Deep Cold Storage
    Holger Roehl, Roche

    15:10
    Group Discussion - Current Materials Used in Deep Cold Temperatures, the Challenges and a Future Outlook

    • Interactions of Drug Products and Primary Packaging Materials at Deep Cold Temperatures
    • Available Solutions and Associated Challenges

    15:30 – 16:00
    Coffee Break, Poster Session & Exhibition

    16:00
    Group Discussion – Current Materials Used in Deep Cold Temperatures, the Challenges and a Future Outlook:

    • Interactions of Drug Products and Primary Packaging Materials at Deep Cold Temperatures
    • Available Solutions and Associated Challenges

    16:30
    Discussion on Hot Topics from the Conference

    17:00
    Conclusion and Farewell

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

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  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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Hilton Molino Stucky Venice

Giudecca 810
Venice, Italy
Phone: +39 041 272 3311

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Hilton Molino Stucky Venice
  • Accommodations

    Hilton Molino Stucky Venice
    Giudecca, 810
    30133 Venezia
    Italy
    Tel: +39 041 272 3311
    Hotel Website

    Once a flourishing flourmill, Hilton Molino Stucky Venice has been beautifully restored and offers a different view of the magical city of Venice. Just 30 minutes from the airport, we also offer a shuttle boat service to the city center. With 379 rooms and suites, the largest Congress Center and the second largest spa in Venice, a collection of bars and restaurants and a stunning rooftop pool, our hotel is the perfect location for your stay in Venice.

    The comfort of their guests is a commitment reflected in the quality and finishes of their 379 rooms. Designed to be a place to unwind, all the rooms offer elegant amenities, spacious marble bathrooms and comfortable beds. Treat yourself with an upgrade and enjoy breathtaking views or access to the Executive Lounge.

    Experience a real taste of the Mediterranean in the elegant Aromi restaurant or savor the authentic flavors of Venetian cuisine at Bacaromi. Spoil yourself with Nutella desserts or relax with a coffee at the lounge. Sip a cocktail Skyline Rooftop Bar enjoying outstanding views over Venice.

    PDA Europe has reserved a limited number of rooms until the 19th December 2018.
    Book your room for the PDA Group Rate.

    Single Room € 209 per night*
    Double Room € 239 per night*

    *Rates are per room and night, including the following services and benefits free of charge:
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    • VAT, Taxes and Service Charge will apply
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How to Get Here

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Nearest Airport: Venice Marco Polo Airport – VCE

Airport Phone: +39 041 260 9260

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Distance: 17 km

Airport shuttle service
Hotel Station: Giudecca Stucky

  • Public Boat: approx. €15 per passenger (one way)
  • Public Bus: approx. €8 per passenger (one way)
  • Public Taxi: approx. €35 per passenger(one way)
Linea Blu Timetable-Public Transportation -Water Taxi - Hilton Venice

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