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2022 PSci-WKS-1988x680 (1)

2022 PDA Packaging Science Workshop

Jun 01, 2022
Basel, Switzerland

Packaging Needs for Advanced Therapies

  • 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 leads, the organizing team, and PDA, we are excited to invite you to join us onsite in Basel, Switzerland on 01 June 2022 for the Packaging Science Workshop! The one-day workshop will prelude the Parenteral Packaging Conference and provide ample room for group discussions and exchange with the leading experts in the field. An interactive afternoon session will ensure key learnings and substantial take-aways for all attendees. Learn about the activities of the Packaging Science Interest Group and how you can benefit from this strong and very active group within PDA.

There is currently an explosion of activity in the area of Advanced Therapy Medicinal Products. These are medicines for human use that are based on genes, cells, or tissues and offer new approaches for the treatment of disease and injury. In addition, the pandemic has proven to be a trigger for mRNA vaccine products, first for addressing the COVID-19 virus but now being expanded to other diseases. These new therapies often introduce new requirements for the primary packaging driven not just by the formulations themselves but also from processes such as the fill & finish process, and storage and distribution requirements. This meeting will stimulate discussions about the future requirements for primary packaging, in particular for the rapidly growing pipeline of ATMP’s and mRNA therapies. When can traditional packaging solutions be used? If traditional solutions cannot be applied, innovative solutions must be developed, tested and verified to meet requirements of these new therapies and meet global regulatory requirements. This meeting brings together the packaging experts from suppliers and pharma companies to share information and work together to implement new approaches and support drug development and manufacturing..

We look forward to meeting you in Basel!

Sincerely,

The IG Leads,

Susan Dounce, SCHOTT
Derek Duncan, LIGHTHOUSE

Organizing team:

  • Susan Dounce, SCHOTT, IG Lead US
  • Derek Duncan, LIGHTHOUSE, IG Lead EU
  • Roger Asselta, Consultant
  • Bettine Boltres, WEST
  • Roman Mathaes, LONZA
  • Xu Song, AstraZeneca
  • 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

Roger P. Asselta
Roger P. Asselta
Auxilium Packaging Advisors
Bettine Boltres
Bettine Boltres
West Pharmaceutical Services
Susan M. Dounce
Susan M. Dounce
West Pharmaceutical Services, Inc.
Derek I. Duncan
Derek I. Duncan
Lighthouse Instruments
Roman Mathaes
Roman Mathaes
LONZA

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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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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