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Immunogenicity and aggregation of therapeutic proteins - American ...

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<strong>Immunogenicity</strong> <strong>and</strong> <strong>aggregation</strong> <strong>of</strong><br />

<strong>therapeutic</strong> <strong>proteins</strong><br />

In cooperation with<br />

Keynote Speakers<br />

John Carpenter<br />

University <strong>of</strong> Colorado<br />

Mary Cromwell<br />

Genentech Inc.<br />

Huub Schellekens<br />

Utrecht University<br />

Poster session – Exhibition<br />

4 th to 5 th October 2011<br />

Berlin, Germany<br />

Course No. 6385<br />

International Association for Pharmaceutical Technology


<strong>Immunogenicity</strong> <strong>and</strong> aggregat<br />

Day 1: <strong>Immunogenicity</strong> <strong>of</strong> Protein Formulation<br />

Tuesday, 4 th October 2011<br />

10.00 to 17.30 h<br />

Welcome<br />

Gerrit Borchard<br />

Université de Genève<br />

Geneva, Switzerl<strong>and</strong><br />

Introduction to the course programme<br />

Gerrit Borchard<br />

Université de Genève<br />

Geneva, Switzerl<strong>and</strong><br />

Innate immunity in protein drug<br />

immunogenicity<br />

N. N.<br />

Utrecht University<br />

Utrecht, The Netherl<strong>and</strong>s<br />

Protein drug formulation & immunogenicity<br />

John Carpenter<br />

University <strong>of</strong> Colorado<br />

Denver, United States<br />

Lunch, poster & exhibition<br />

The role <strong>of</strong> protein charge <strong>and</strong> proximity<br />

energies in <strong>aggregation</strong> <strong>and</strong> viscosity<br />

Pr<strong>of</strong>. Thomas M. Laue<br />

University <strong>of</strong> New Hampshire<br />

Durham, United States<br />

<strong>Immunogenicity</strong> in preclinical testing<br />

Anja Langenkamp<br />

Roche AG<br />

Basel, Switzerl<strong>and</strong><br />

C<strong>of</strong>fee break, poster & exhibition<br />

Regulatory requirements for immunogenicity<br />

testing<br />

Brigitte Brake<br />

Bundesinst. f. Arzneimittel u. Medizinprodukte<br />

(BfArM)<br />

Bonn, Germany<br />

Panel discussion, Q & A<br />

City tour <strong>and</strong> networking dinner<br />

Day 2: Protein Aggregation<br />

Wednesday, 5 th October 2011<br />

09.00 to 16.00 h<br />

Welcome<br />

Karoline Bechtold-Peters<br />

Roche AG<br />

Basel, Switzerl<strong>and</strong><br />

Protein <strong>aggregation</strong><br />

Jamie Moore<br />

Genentech Inc.<br />

South San Francisco, United States<br />

Detection <strong>and</strong> characterization <strong>of</strong> particles in<br />

drug products<br />

Hanns-Christian Mahler<br />

Roche AG, Basel, Switzerl<strong>and</strong><br />

C<strong>of</strong>fee break, poster & exhibition<br />

Freeze-drying <strong>and</strong> aggregates<br />

Andrea Wiggenhorn-Hawe<br />

Coriolis Pharma Services GmbH<br />

Martinsried, Germany<br />

Orthogonal methods for aggregate analysis<br />

Kay Vogel<br />

Boehringer Ingelheim Pharma GmbH und Co. KG<br />

Biberach/Riss, Germany<br />

Lunch, poster & exhibition<br />

Influence <strong>of</strong> packaging on protein <strong>aggregation</strong><br />

Linda Narhi<br />

Amgen Inc.<br />

Thous<strong>and</strong> Oaks, United States<br />

Stabilization <strong>of</strong> highly concentrated protein solutions<br />

Tudor Arvinte<br />

Therapeomic Inc.<br />

Basel, Switzerl<strong>and</strong><br />

Panel discussion, Q & A <strong>and</strong> closing<br />

Programme is subject to change


on <strong>of</strong> <strong>therapeutic</strong> <strong>proteins</strong><br />

In cooperation with<br />

Therapeutic protein c<strong>and</strong>idates are increasingly entering the pipelines <strong>of</strong> pharmaceutical companies<br />

<strong>and</strong> the marketplace in spite <strong>of</strong> production, formulation <strong>and</strong> safety challenges encountered. This 2day<br />

conference held under the auspices <strong>of</strong> APV (www.apv-mainz.de) <strong>and</strong> AAPS (www.aaps.org) will<br />

focus on issues in immunogenicity <strong>and</strong> protein <strong>aggregation</strong> by gathering opinion leaders from academia,<br />

industry <strong>and</strong> regulatory authorities for an update on the state-<strong>of</strong>-the-art. The conference will<br />

also <strong>of</strong>fer to students the presentation <strong>of</strong> their latest results in poster format, <strong>and</strong> the display <strong>of</strong><br />

advanced analytical technology to suppliers in an industrial exhibition.<br />

Karoline Bechtold-Peters, Roche AG, Basel, Switzerl<strong>and</strong><br />

Gerrit Borchard, University <strong>of</strong> Geneva, Switzerl<strong>and</strong><br />

Dr. Michael Wiggenhorn, Coriolis Pharma Services GmbH, Martinsried, Germany<br />

AAPS<br />

The <strong>American</strong> Association <strong>of</strong> Pharmaceutical Scientists<br />

is a pr<strong>of</strong>essional, scientific society <strong>of</strong> more than<br />

12,000 members employed in academia, industry,<br />

government <strong>and</strong> other research institutes worldwide.<br />

Founded in 1986, AAPS provides a dynamic international<br />

forum for the exchange <strong>of</strong> knowledge among<br />

scientists to enhance their contributions to public<br />

health. AAPS <strong>of</strong>fers timely scientific programs, ongoing<br />

education, information resources, opportunities<br />

for networking, <strong>and</strong> pr<strong>of</strong>essional development.<br />

APV – Making Science Work<br />

APV is the pharmaceutical non-for-pr<strong>of</strong>it<br />

association in German-speaking countries <strong>and</strong> in<br />

Europe for everyone involved in the field <strong>of</strong> pharmaceuticals.<br />

We support pharmaceutical sciences <strong>and</strong><br />

technology as well as all related disciplines, circulate<br />

knowledge <strong>and</strong> knowhow from these fields <strong>and</strong><br />

represent the scientific interests in these areas in academia,<br />

the industry <strong>and</strong> regulatory authorities. Our<br />

society promotes research <strong>and</strong> development in academia<br />

<strong>and</strong> in the industry <strong>and</strong> a platform for sharing<br />

<strong>and</strong> spreading scientific information related to<br />

pharmaceuticals. We enhance pr<strong>of</strong>essional skills by<br />

conducting high-quality training seminars.<br />

As experts, we contribute to opinion making<br />

in the relevant authorities, associations <strong>and</strong> in the<br />

public press. We publish our own scientific journal<br />

(EJPB – European Journal <strong>of</strong> Pharmaceutics <strong>and</strong><br />

Biopharmaceutics).


Abstract Submission:<br />

You are kindly invited to submit abstracts for poster presentations<br />

during the conference.<br />

Please send all abstracts (2 pages) to mb@apv-mainz.de<br />

Deadlines:<br />

Call for Abstracts – Open 15 th April 2011<br />

Abstract Submission – Deadline 1 st August 2011<br />

Notification <strong>of</strong> Acceptance – 1 st September 2011<br />

Social Programme:<br />

A city tour <strong>and</strong> networking dinner will give the participants the<br />

opportunity to get together.<br />

Exhibition <strong>and</strong> sponsoring:<br />

For exhibition <strong>and</strong> sponsoring opportunities please contact the APV<br />

headquarters<br />

Phone +49 6131 9769-85<br />

e-mail it@apv-mainz.de<br />

Register by Tuesday 31 st May 2011 to take advantage <strong>of</strong> the early bird fee<br />

Course No. 6385<br />

<strong>Immunogenicity</strong> <strong>and</strong> <strong>aggregation</strong> <strong>of</strong> <strong>therapeutic</strong> <strong>proteins</strong><br />

Berlin, Germany, 4 th to 5 th October 2011<br />

Title, First Name, Name<br />

Company/institution name<br />

Company/institution address<br />

Phone Fax<br />

e-mail Order no.<br />

Position in Company/institution Department<br />

APV member Non-member<br />

Date Signature<br />

Date<br />

Course No. 6385<br />

from 04 th Oct. 2011 10:00<br />

to 05 th Oct. 2011 16:00<br />

Location<br />

Holiday Inn Berlin City-West<br />

Rohrdamm 80<br />

13629 Berlin, Germany<br />

Phone: +49 30 38389-0<br />

Fax: +49 30 38389-900<br />

Early bird Full fee<br />

Member <strong>of</strong> APV 1260 EUR 1360 EUR<br />

Non-Member <strong>of</strong> APV 1390 EUR 1490 EUR<br />

Member <strong>of</strong> APV (Academic, Governmental) 630 EUR 680 EUR<br />

Non-Member <strong>of</strong> APV (Academic, Governmental) 695 EUR 745 EUR<br />

Member <strong>of</strong> APV (Students) 120 EUR 150 EUR<br />

Registration<br />

All correspondence regarding the<br />

conference should be addressed<br />

to:<br />

APV-Geschäftsstelle<br />

Kurfürstenstraße 59<br />

55118 Mainz/Germany<br />

Phone: +49 6131 9769-0<br />

Fax: +49 6131 9769-69<br />

e-mail: apv@apv-mainz.de<br />

You will receive a confirma-tion<br />

<strong>of</strong> your registration with the<br />

invoice.

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