Events

BioM Seminar: Impurities in Biologics - Pyrogens & Endotoxins

This seminar will give an overview of the current issues for endotoxin testing and highlight the future trends improving Quality Control of drug product manufacturing.

Time and Place
Thursday, December 13, 2018, 13:00 – 17:00
BioM Biotech Cluster Development GmbH
Am Klopferspitz 19 a (IZB West II, 3. OG)
82152 Martinsried

Content
and Goal
Endotoxin, a cell wall component of Gram-negative bacteria, can cause varying levels of immune responses when introduced to the blood system. As a result, the onus is on the manufacturers of all parenteral drugs to control possible endotoxin contamination throughout the manufacturing process.

As new technologies develop, test methods like the Recombinant Bacterial Endotoxin Test (rBET) or Monocyte Activation Test (MAT) are available and ready for application in the quality control landscape of drug manufacturers.

In this seminar the regulatory status well as expectations by users of such new methods are highlighted. Furthermore, the phenomenon of Low Endotoxin Recovery (LER) is discussed. Taken together this will give an overview of the current issues for endotoxin testing and highlight the future trends improving Quality Control of drug product manufacturing.

Main topics

  • Standard and alternative methods
  • Low Endotoxin Recovery
  • Regulatory aspects
  • Trends in Quality Control

The presentations will be held in English.

Target group
•    Scientific staff from the area Endotoxin testing
•    Laboratory management and staff of pharmaceutical microbiology
•    Researchers from pharmaceutical development of biologics, gene therapy and cell therapy

Speakers
Anders Thorn
M.Sc. Pharm., Specialist, Microbial Competence Centre, Novo Nordisk A/S

Dr. Ingo Spreitzer
Section 1/3 Microbial safety, Deputy, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines

Dr. Johannes Reich
Microcoat Biotechnology GmbH

Agenda
13.00-13.15        Welcome & Introduction
13.15-14.15        Test methods and Pharmacopoeial developments (Paul-Ehrlich-Institut, Ingo Spreitzer)
14.15-15.15        Low Endotoxin Recovery - Considerations for early drug development and regulatory (FDA) expectations (Dr. Johannes Reich, Microcoat)
15.15-15.45        Coffee Break
15.45-16.45        Case Study - Low Endotoxin Recovery (Novo Nordisk, Anders Thorn)
16.45-16.30        Q&A
16.30-18.00        Closing and Networking

Organisation
Gabriele Klingner and Dr. Andreas Berghammer
BioM Biotech Cluster Development GmbH
Email: klingner@remove-this.bio-m.org 
Phone: +49 (0) 89-899679-15
Email: berghammer@remove-this.bio-m.org 
Phone.: +49 (0) 89-899679-17

Registration
Registration fee: 80 Euro (+ VAT) for Academia, 130 Euro (+ VAT) for Industry