Immunogenicity and aggregation of therapeutic proteins - American ...
Immunogenicity and aggregation of therapeutic proteins - American ...
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.