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Impact of Pre-Filled Syringe Components on Biopharmaceuticals Workshop

Oct 21, 2019
Gothenburg, Sweden

  • Workshop
  • Europe

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Program Highlights

PDA is planning a series of workshops as a kick-off to the Universe of Pre-filled Syringes Meeting. The workshop topics are soon to be published – check the website regularly or to send us an email we will inform you when these go online.

Overview

Biotherapeutics remain the largest growing segment in the pharmaceutical industry, spurred by various technological advancements in many fields and with further progress in understanding diseases. Moreover, advanced therapy medicinal products (ATMPs) offer ground-breaking new opportunities for the treatment of currently untreatable diseases or provide for additional effective and curative treatment options.

These advances in pharmacotherapy are also giving challenges and hurdles, with regulators becoming increasingly stringent. It is critical to consider potential interactions with primary packaging components and direct contact materials. The importance of pre-filled syringes and other pre-filled drug containers, often used in combination with drug delivery devices, cannot be underestimated within this space of parenteral drug delivery.

This workshop will address various aspects regarding potential influences from primary packaging components and materials on drug quality, safety and efficacy, including the influence of sub-visible particles, extractables and leachables, silicone oil, handling and manipulation, e.g. aggregation, protein degradation routes and stability.

This workshop will bring together experts from academia, the pharmaceutical industry and providers of primary packaging components to share their experiences. There will be plenty of time allocated for discussion and interaction with the audience.

Agenda

  • Monday, 21 October 2019

    10:00
    Welcome: Opening Remarks & Introductions
    Philippe Lauwers, Terumo

    Opening - Keynote Presentations

    10:15
    Formulation and Primary Packaging Optimizations for Biopharmaceuticals in Pre-filled Syringes
    Susumu Uchiyama,
    Osaka University

    10:45
    Interactive Group Session – Creating a Mind Map

    Roman Mathaes, LONZA

    11:15
    Coffee Break & Exhibition

    11:45
    Primary Packaging Material: One of Several Suspects Causing Immunogenicity

    Guenter Waxenecker, AGES

    12:15
    Interactive Group Discussion – Creating a Mind Map

    Roman Mathaes, LONZA

    12:45
    Lunch & Exhibition

    13:45 - 15:15
    Interactions between Primary Packaging Components, Drug Product and Functionality

    13:45
    Influence of Surface Treatment on Migrating Components from the Elastomeric Closure 

    Simon Kervyn, Datwyler

    14:15
    Using Drug Container Interaction Screening Methods to Design a Robust Syringe - Autoinjector Functionality

    Robert Hormes, Novartis

    14:45
    Interactive Group Discussion - Creating a Mind Map

    Roman Mathaes, LONZA

    15:15
    Coffee Break & Exhibition

    15:45
    Extractables & Leachables: Chemical Interactions Between Leachables and Biopharmaceuticals 

    Koen Nuyts, Nelson Labs

    16:10
    Polysorbate – a Relevant Excipient for Biopharmaceuticals in Pre-filled Syringes

    Andrea Hawe, Coriolis Pharma

    16:35
    Finalizing the Mind Map & Workshop Summary

    Roman Mathaes, LONZA
    Philippe Lauwers, Terumo

    17:00
    End of Workshop and Farewell

    Philippe Lauwers, Terumo

Highlighted Speakers

Philippe Lauwers
Philippe Lauwers
Terumo Pharmaceutical Solutions

Additional Information

  • Who Should Attend

    Professionals involved in research, development and manufacturing of biopharmaceuticals, primary drug container and parenteral drug device development, quality and regulatory.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

The Swedish Exhibition & Congress Centre Gothia Towers Hotel

Mässans Gata 24
Gothenburg, Sweden

Make a Reservation

The Swedish Exhibition & Congress Centre Gothia Towers Hotel
Mässans Gata 24
41294 Gothenburg, Sweden


Hotel Accommodation

optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2019. We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting an official PDA Europe hotel.

You can book your Hotel Accomodation here!
  • Accommodations

    The Swedish Exhibition & Congress Centre Gothia Towers Hotel
    Mässans Gata 24
    41294 Gothenburg, Sweden


    Hotel Accommodation

    optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2019. We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting the conference hotel.

    You can book your Hotel Accomodation here!

  • Amenities

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €795

All fees given in Euro and excluding VAT (25%)

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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