1st International Symposium on
Highly Potent Drug Substances and
their Formulations
Join us on February 10-11, 2015!
Overview
Date
February 10-11, 2015
Symposium language
English
Venue
Evonik Industries AG
Kirschenallee 45
64293 Darmstadt
Germany
Evening event
All workshop participants are cordially invited to our
evening event on February 10, 2015.
Participation fee
Free of charge
Accommodation
We have arranged an allotment of rooms at
several nearby hotels. For further information
please see the invitation e-mail.
Registration
Log in to our online platform e-Lab at www.evonik.com/e-lab
and register in our “Workshop Cockpit” in just a few steps.
Questions?
If you have questions on the symposium or need
assistance with your travel planning please do not
hesitate to contact Mr. Dennis Görges
([email protected]).
Agenda day 1
08.30 a.m.
Registration & welcome coffee
12.30 p.m.
Lunch
09.00 a.m.
Welcome & introduction
Dr. Brigitte Skalsky (Evonik Industries AG, Germany)
Dr. Matthias Rischer (Losan Pharma GmbH, Germany)
02.00 p.m.
The challenges of low dose, high potency, low solubility APIs with
respect to cleaning validation and cross-contamination control strategies
NN (Evonik Corporation, USA)
09.30 a.m.
High potency drugs - definition, production, formulation, packaging
Prof. Dr. Axel Kleemann (University of Frankfurt, Germany)
02.45 p.m.
10.10 a.m.
Hazard evaluation and containment standards for handling HPAPIs
Kenny McCleary (Evonik Corporation, USA)
Dr. Kai Blumbach (Evonik Industries AG, Germany)
Design, qualification and points to consider for an OEL class 3B area
Dr. Friederike Mayenfels (Losan Pharma GmbH, Germany)
Martin Hagedorn (Losan Pharma GmbH, Germany)
03.30 p.m.
Coffee break
04.00 p.m.
Analytical methodologies for HPAPIs in development and QC
NN (AQura GmbH, Germany)
10.45 a.m.
Coffee break
11.15 a.m.
Case study: HPAPI process development and lab scale implementation
Dr. Alexandru Gheorghe (Evonik Industries AG, Germany)
Dr. Jochen Becker (Evonik Industries AG, Germany)
04.45 p.m.
SHE Monitoring in highly potent production environment - needs and
how to fulfill them
Konstantin Blümel (SHE Consultant, Germany)
11.50 a.m.
Case study: commercial scale HPAPI production
NN (Evonik Corporation, USA)
05.15 p.m.
End of day 1
07.00 p.m.
Evening event
Agenda day 2
08.30 a.m.
Recap day 1
09.00 a.m.
Practical lab demonstrations with Evonik and industry experts
• Containment concepts used in Evonik‘s oral formulation
development labs
03.00 p.m.
Formulation challenges in the lab - special considerations when
developing a HPAPI as a controlled release dosage form
Dr. Kevin Burton (Evonik Corporation, USA)
03.40 p.m.
Case study lyophilization: Special considerations for
manufacturing and QC when handling a HPAPI as a parenteral
controlled release dosage form
Dr. Kevin Burton (Evonik Corporation, USA)
Kenny McCleary (Evonik Corporation, USA)
04.10 p.m.
Evonik services in HPAPI drug substances and dosage forms
Dr. Klaus Stingl (Evonik Industries AG, Germany)
Dr. Kevin Burton (Evonik Corporation, USA)
04.30 p.m.
Conclusion
05.00 p.m.
End of workshop
Room for individual expert discussions
• Containment approaches for hot melt extrusion
• Exposure monitoring methods
• Fluorescent materials as training tools
12.00 p.m.
Lunch
01.00 p.m.
The importance of API potency in controlled release dosage forms
Dr. Tom Tice (Evonik Corporation, USA)
01.45 p.m.
Nanocarriers for cancer therapy - rational formulation design
Dr. Matthias Wacker (University of Frankfurt)
02.30 p.m.
Coffee break