Lyo Summit 2012 - Agenda

LYO SUMMIT 2012 - Programme
  Day 1 - Moday, October 1st, 2012
Venue Hotel Eibsee, Grainau
01:00 - 02:00 pm

Registration/Conference Folder Handout

Christina Scherlin, iQ-mobil solutions GmbH

01:00 - 02:15 pm

Welcome

Dr. Andrea Weiland, Explicat Pharma GmbH
Anton Mangold, iQ-mobil solutions GmbH

02:15 - 02.30 pm

Introduction into TEMPRIS® LYO-SUMMIT – Agenda

Dr. Andrea Weiland, Explicat Pharma GmbH

02:30 - 03:00 pm

Fundamental Principles of Lyophilization Scale Up

PD Dr. Henning Gieseler, Gilyos GmbH

03:00 - 03:30 pm Understanding and Optimizing the Freeze Drying Cycle Utilizing SMART™ & ControLyo™ Nucleation on demand technology

Ake Karlsson, SP Scientific
03:30 - 04:00 Coffee Break
04:00 - 04:45 pm
 
TEMPRIS® - Components and Operation Principle

Requirements on the Quality Management System
of a PAT measurement device used for lyophilization


Geri Richter, Gericon Unternehmensberatung 
Anton Mangold, iQ-mobil solutions GmbH
04:45 - 05:15 pm

Experiences with the application of TEMPRIS® during the transfer from development scale to production scale

Dr. Andrea Weiland, Explicat Pharma GmbH

05:15 - 06:00 pm

TEMPRIS GMP Environment, Commercial Production Experiences of a contract manufacturer (Part 1)

Christoph Graf, Recipharm (Wasserburger Arzneimittelwerk)

06:00 - 06:30 pm

Question & Answer Session

Moderator: Manfred Baumeister, iQ-mobil solutions GmbH

Venue Eibsee-Alm
07:30 pm

LYO SUMMIT Dinner “Bayerische Almhüttn” with traditional food, beer, and music

  Day 2 - Tuesday, October 2nd, 2012
Venue  Hotel Eibsee, Grainau
09:00 - 10:00 am

TEMPRIS GMP Environment, Commercial Production Experiences (Part 2)

Miha Andrejasic, LEK Pharmaceuticals / Sandoz

10:00 - 10:15 am Coffee Break
10:15 - 10:45 am

Value and Limitations of Temperature Measurement in Lyophilization

Dr. Ingo Presser, Boehringer Ingelheim

10:45 - 11:15 am

Case Study: Wireless Temperature Measurement to Support Process Transfer in Different Freeze Dryers at Production Scale

Dr. Ingo Presser, Boehringer Ingelheim

11:15 - 12:00 am

Discussion - Lyo Product Transfer

Moderation: Dr. Andrea Weiland, Explicat Pharma GmbH

12:00 - 13:30 pm LYO SUMMIT Lunch
13:30 - 14:00 pm

TEMPRIS System: Integration into freeze-dryer control system, calibration & qualification in a GMP environment

Dr. Jörg Lümkemann, Hoffmann-La Roche, Basel, Head of Pharmaceutical Engineering Support and New Technologies within the Formulation and Device Development Biologics Europe

14:00 - 16:00 pm

Question* & Answer Session, Trouble Shooting

  • Integration of TEMPRIS in Freeze Dryers, Scada etc.
  • Tp as online parameter to control the Lyo-cycle
  • Return on Investment / Cost Savings

* You are invited to send your questions to us in advance

Moderation: Anton Mangold, iQ-mobil solutions GmbH

16:00 pm

End of Conference LYO SUMMIT 2012 - Farewell

Anton Mangold, iQ-mobil solutions GmbH