Pre-Conference-Workshop Impact of Pre-filled Syringe Packaging Components on Biopharmaceuticals

Vienna, Austria
Ask a Question Exhibitor Standard Contract Clause

Parenteral drug delivery using pre-filled syringes and cartridges in combination with devices is of great importance, especially for the application of biopharmaceutical products.

The development of such delivery systems is complex and therefore it is important to consider critical aspects early on in development. This workshop considers the potential influences of primary packaging components on the quality, in particular for biopharmaceuticals. The most relevant aspects are the quality and the chemical and physical interactions of the packaging material with the product. Special considerations are given to the influence of particles, extractables and leachables, silicon oil and handling on the product quality, e.g. aggregation, degradation routes and stability. Experts from academia, the pharmaceutical industry and suppliers of packaging components will share their experiences. There will be plenty of time for discussion, interaction and questions you may have.

More information coming soon.


WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Monday, 6 November 2017

William Dierick,
Director, Technology Development – Pharmaceutical Solutions, Co-Chair, TERUMO
John Carpenter, Professor of Pharmaceutical Sciences, Co-Chair,University of Colorado


Aggregates, Particles and Patient Immunogenicity with Biopharmaceuticals
John Carpenter, University of Colorado

Factors Affecting Stabilities of Biopharmaceuticals in Pre-filled Syringes
Susumu Uchiyama, Osaka University

Packaging Components and Biopharmaceuticals: Quality Aspects from Industry Perspective
Hanns-Christian Mahler, Lonza

Q&A - Discussion

Coffee Break

Session 1 Aggregation Phenomena

Protein – Device Compatibility
Flora Felsovalyi, Roche

Characterization of Particles and Practical Implications
Linda O. Narhi, Amgen

Ex-Vivo Risk Assessment of Immunogenicity
Mark Fogg, Abzena

Q&A - Discussion

Coffee Break

Session 2 Particles

Particulates in Sterile Drug Products: Testing, Contributions and Mitigation from Packaging Components
Fran DeGrazio, West

Particles in Packaging Components: Numbers and Chemical Composition
Markus Lankers , Rap.ID

Q&A - Discussion

Session 3 Extractables & Leachables>

Extractables and Leachables: Impact of Packaging Components on Biopharmaceuticals
Piet Christiaens, Toxikon

Session 4 Functionality

Needle Clogging of Staked-In-Needle PFS with High Concentration Protein Therapeutics
Monica De Bardi, Roche

Q&A - Discussion

Closing Remarks by Co-Chairs

End of Workshop

Agenda is subject to change.

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.

Austria Center Vienna
Internationales Amtssitz- und Konferenzzentrum Wien, AG
Bruno-Kreisky-Platz 1
A-1220 Vienna

Hotel Accommodation

optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2017 . 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.