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2022 PfSyringes-WKS-1988x680

2022 PDA Pre-filled Syringes Workshop

Jun 01, 2022
Basel, Switzerland

A New Generation of Syringes: Advanced Technologies and Next Steps

  • Workshop
  • Europe

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Program Highlights

AMENDED AGENDA!
2022 PDA Pre-Filled Syringes Workshop & 2022 PDA Packaging Science Workshop have joined forces to give you the best input on both topics combined into one interactive workshop!

Overview

Dear Colleagues,

On behalf of the IG Lead, the Organizing Team and PDA, we are excited to invite you to join us onsite in Basel/Switzerland on 01 June 2022 for the Pre-filled Syringes Workshop! The one-day workshop will prelude the Parenteral Packaging Conference. An interactive afternoon session will ensure key learnings and substantial take-aways for all attendees.

Complex and sensitive drug products e.g. Monoclonal Antibodies, Oligonucleotides that have the potential to improve or advance existing treatments for patients around the world who rely on them for their health and well-being. To be successful, these companies depend on a continuous flow of new technologies for primary packaging systems, processes, and drug product manufacturing. Innovative solutions must be developed, tested and verified in order to fulfill global regulatory requirements. This means suppliers and pharma companies must work in harmony to implement these new technologies and support drug development and manufacturing.

The goal of this meeting is to examine and discuss in detail the many challenges that must be overcome for drugs administered in pre-filled syringes with a sharp focus on:

  1. New technologies that have the potential to improve drug products shelf-life: Including silicone free/low silicone solutions, particle reduction, etc.
  2. News technologies that support flexibility in drug product manufacturing: Including modularity in fill & finish, automated inspection and packaging solutions
  3. Moving from Vials to PFS – With attention to the many hurdles the industry must overcome in phase 3 studies when moving from vials to PFS for vaccines 
  4. Traceability – An in-depth analysis of this new technology using case studies that shed light on how traceability is helping to ensure the integrity of the product and safety of the patient, reducing manufacturing costs and contributing to regulatory compliance.
The open forum design of the workshop will provide participants the opportunity to hear presentations from leading experts and ample time for discussing your experiences with colleagues in an information sharing atmosphere. Expand on your existing knowledge while freely exchanging opinions in an interactive format. Acquire the latest information about activities of the Interest Group Pre-Filled Syringes. 
Do not miss out on this important learning opportunity! 

 

We look forward to meeting you in Basel!

Sincerely,

The IG Lead,

Brigitte Reutter-Haerle, Vetter

ORGANIZING TEAM:
  • Brigitte Reutter-Haerle, Vetter, IG Lead
  • Frank Bamberg, CSL Behring
  • Philippe Lauwers, Terumo
  • Gabriele Peron, Stevanato Group
  • Falk Klar, PDA Europe
  • Caroline Lynar, Jr. Manager Programs & Events, PDA Europe

Agenda

  • Wednesday, 01 June 2022

    09:00

    Welcome and Introduction
    Brigitte Reuter - Haerle, Vetter Pharma
    Derek Duncan, Lighthouse Instrument

    09:05 I Container / Closure Development for Covid Vaccine
    Satish Singh, Moderna

    09:30 I Rising to the Challenge of Process Robustness for Primary Packaging -Innovative Strategies
    Michael Edey, Pfizer

    09:55 I Learning from Helium pCCI Testing Using Modular Positive Controls
    Christian Proff, Roche

    10:20 | Coffee Break

    10:35 I Enabling Modular Filling for PFS: Development Path and Technical Challenges
    Matthieu Giletti, Roche
    Simon Lay, Cytiva

    11:00 I New Technologies from Different Suppliers: Overall Comparison Between Silicone Free Solutions
    Jacopo Michieli, CSL Behring

    11:25 I Needle Clogging of Protein Solutions in Pre-filled Syringes – A Two-stage Process with Various Determinants
    Stefan Scheler, Novartis

    11:50 I Q&A, Discussion

    12:20 | Lunch Break

    Track A: Interactive Session
    After parting into 3 groups the participants will enter a structured conversational process regarding Container Closure Integrity for Pre-filled Syringes, Discussing Requirements for Next Generations Syringes, and New Technology Fill & Finish in 3 rounds. Facilitated by a table moderator, each group is introduced to the topic and will have a set amount of time to discuss and gather key points on each topic. As each group will build on the knowledge already gathered each round will be shorter than the prior. Inspired by the method developed by Juanita Brown and David Isaacs this session will result in inconclusive take-home messages on each topic discussed.

    13:15 I Introduction
    Frank Bamberg, CSL Behring

    Group 1 - Container Closure Integrity for Pre-filled Syringes
    Frank Bamberg, CSL Behring

    Group 2 - Discussing Requirements for Next Generations Syringes
    Brigitte Reutter-Haerle, Vetter Pharma

    Group 3 - New Technology Fill & Finish
    Vincenza Pironti, Thermofisher & Gabriele Peron, Stevanato Group

    13:25 I Round 1

    13:45 I Round 2

    14:05 I Round 3

    14:25 I Summary of the World Café

    14:40 | Coffee Break

    15:10 I Moving from Vials to PFS – Hurdles the Industry Faces in Phase 3 Studies when Moving from Vials to PFS for Vaccines
    Vincenza Pironti, Thermofisher

    15:35 I Q&A, Discussion

    Track B: Site Visit Novartis Campus 
    Departure: 12:45

    Participants have the opportunity to visit the campus of Novartis

     

    15:45 I Traceability: Using Data-driven Process Optimization to Deliver Increased Output from Existing Investments
    Tod Urquhart, Eagas SLU

    16:10 I Pre-filled Syringes in Early Drug Development States
    Flora Felsovalyi, Roche

    16:40 I Q&A, Discussion

    16:50 I Farewell and Current Activities of the IG Meeting Pre-Filled Syringes & IG Meeting Packaging Science

    Brigitte Reutter-Haerle, Vetter Pharma
    Frank Bamberg, CSL Behring
    Derek Duncan, LIGHTHOUSE Instruments
    Bettine Boltres, WEST

    17:00 | End of Workshop

Highlighted Speakers

Frank Bamberg
Frank Bamberg
CSL Behring
Philippe Lauwers
Philippe Lauwers
Terumo
Gabriele Peron
Gabriele Peron
Stevanato Group
Brigitte Reutter-Haerle
Brigitte Reutter-Haerle
Vetter Pharma International GmbH

Additional Information

  • Who Should Attend

    More information coming soon.

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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.

Congress Center Basel

Messeplatz 21
Basel, Switzerland

Congress Center Basel
  • Accommodations
    Hotels Nearby

    PDA Europe recommends the reservation at one of the following hotels.
    The general terms of business are valid at the event hotels.


    Pullman Basel Europe
    Clarastrasse 43
    4058 Basel
    Switzerland
    Tel: +41616908080

    The Pullman Basel Europe is a vibrant and outstanding upscale hotel within walking distance of the old town, the Rhine river and only 200 m from the Congress Center Basel (Messe). Apart from the fashionable and luxuriously appointed rooms, the modern Fit Lounge and a charming bistro with regional cuisine, it also boasts a green inner courtyard to relax.

    The Basel SBB Train Station is 2 km away and there is parking space available for free for guests. Guests benefit from free access to public transport in Basel with the complimentary Basel Card. 


    Hyperion Hotel Basel
    Messeplatz 12
    4058 Basel
    Switzerland
    Tel: +41 61 5604000

    The Swissôtel Basel (4**** superior) offers elegant guest rooms and real Swiss hospitality for an authentic Alpine experience. The rooms boast hand-picked, unique furnishings and calming tones with splashes of vibrant yellow. In-room technology, WiFi, workspaces and entertainment centres are complemented with Italian coffee machines and quality en-suite amenities to help you get the most out of your stay.

    It is centrally located directly connected with the Congress Center Basel (Messe) and within walking distance of the old town, the Rhine River and numerous sight-seeing spots.

    The Basel SBB Train Station is 2 km away and there is parking space available for free for guests. Guests benefit from free access to public transport in Basel with the complimentary Basel Card.

  • Amenities

How to Get Here

By Air

Congress Center Basel:

Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 8km from the venue. A direct bus (Line Nr. 50) runs every 20 minutes A direct bus (Line Nr. 50) runs every 20 minutes taking you to the SBB train Station. A taxi takes approximately 10-20 minutes to the venue.

By Car

Congress Center Basel

The exhibition and congress site has its own direct link to the A2 motorway. The “Messe” exit will take you straight to the Messe Basel car park with its 1,200 parking spaces.

Other Options

Congress Center Basel

  • From the SBB/SNCF railway station, it’s a ten-minute journey on the No. 1 or 2 Tram to the “Messeplatz/Exhibition Square” stop where Messe Basel and the Congress Center are located. From Badischer Bahnhof railway station, “Messeplatz/Exhibition Square” is the second stop on the No. 2 or 6 tram.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €450

* For this member type or discount, online registration is not available, please contact [email protected].

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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