European Microbiology Conference and pre-Conference Workshop on Bioindicators

10-12 May 2016

Barcelona, Spain

Course No 15194

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Speakers

Authority and Pharmacopoeial Speakers:
Dr Isabelle Bekeredjian-Ding, PEI – German Agency for Vaccines and Biomedicines
Dr Lynne Ensor, FDA, USA
Dr Andreas Kurth, Robert Koch-Institute, Germany
Dr Erika Pfeiler, FDA, USA
Donald C. Singer, Vice Chair of USP Microbiology Expert Committee

Industry and Laboratory Speakers:
Andrea Calda, AM-Instruments, Italy
Dr Jörg Degen, Eurofins BioPharma Product Testing Munich GmbH, Germany
Dr Sven M. Deutschmann, Roche Diagnostics, Germany
Dr Heike Esch, SKAN AG, Switzerland
Dr Marcel Goverde, MGP, Switzerland
Dr Ulf Gurok, Roche Diagnostics, Germany
Prasanna Khot, CRL, USA
Arjan Langen, MSD, The Netherlands
Dr Ingrid Mecklenbräuker, Novartis, Switzerland
Andrea Pranti, GSK Vaccines, Italy
Dr Tim Sandle, BPL, United Kingdom
Matthias Schaar, Novartis Pharma Stein, Switzerland
Robert Schwarz, Baxalta, Austria
Kevin Williams, Lonza, USA

Objectives

This event offers you a unique possibility to become acquainted with ongoing regulatory requirements, the development of microbiological methods for quality and process control as well as with the recent experiences in microbial contamination control.
Speakers from different scopes of pharmaceutical microbiology will give you the chance to get to know the different views on versatile microbiological topics. Also, as a participant you will have ample opportunity to discuss your specific issues with speakers and other participants.
Interdisciplinary Key Note lectures will give you an additional benefit for understanding the current developments in pharmaceutical QC.

Background

The role of pharmaceutical microbiology is getting more and more important. It is also increasingly in the focus of regulators during product submission and inspections. Current challenges are Low Endotoxin Recovery, implementation of alternative microbiological methods and the ongoing issues with contamination control – there were an increasing number of findings in the authority reports.
The challenge is therefore to satisfy regulatory requirements alongside management’s financial expectations.

Target Group

This conference is of interest to professionals in microbiology from pharmaceutical and biopharmaceutical companies
Academic research institutions
Government agencies
Contract service laboratories
who are involved in
Contamination control
Monitoring
Validation
Quality affairs
Regulatory affairs
Research and development

Programme

Pre-Conference Workshop on Bioindicators:

The Various Roles of Biological Indicators in Pharmaceutical Manufacturing –
an FDA Perspective
BIs as load monitors – FDA’s parametric release policy
BIs in validation and qualification – are reduced incubation times and/or reduced spore counts appropriate?
Evolution of the FDA’s Centers perspectives on BI use for drugs and devices
Case studies of BIs in sterility assurance

BI in sterilisation validation – old hat or state of the art with pitfalls?
Comparative D-value study
Time is money – Potential for optimizing analytics
F-value concept vs biological system

Bioindicators – expectations and reality
Expectations from regulatory requirements, customers and manufacturers
H2O2 Biological Indicators (BI): Model behaviour of BI and design of BI components

Biological indicators – helpful tools for process validation
Product types
Test strains
Characteristics
Manufacturer’s and user’s responsibilities
Application
Methods

Pharmacopoeial Requirements in USA
Relevant chapters
Last developments and revisions

Incoming control of bioindicators for steam sterilization – practical example
Requirements
Spore count determination
D-value determination

European Microbiology Conference:

FDA‘s reorganisation – a brief overview
Current status
Structure and responsibilities
Impacts for industry

Current Pharmacopoeial Developments in USA
Current Revisions and adopted monographs
Effects for Microbiology

Key points for the verification of environmental monitoring methods
Am I using the right culture medium? Should one or two media be used?
How long should I incubate plates for?
How long can settle plates be exposed for under undirectional airflow?
How effective is your air-sampler disinfection?
What is the optimal time and pressure for taking a contact plate?

Recovery rates of different environmental monitoring methods
Comparison of different swabs for their efficacy
Review of study results on recovery rates
Importance of in situ studies

Holding Studies and Microbial Challenge Tests
Review of some challenges in Antimicrobial Effectiveness Testing of preserved
and non-preserved products
Microbial growth promotion test and determination of growth rates for different test strains
Microbial Challenge Test and Bioburden simulation
Case studies and failure investigations

Microbiological Qualification of Process Hold Times during Biotech API Manufacturing
Different approaches to microbiological qualification of process hold times
Examples from Biotech API manufacturing processes
Impact of qualification results

Case Study 1 Concept for the Hold Time Program of Coating Suspensions
Strategy for aqueous intermediates of non-sterile products: Overview and risks
Experimental holding time determination: Challenges and case studies
Qualification and annual monitoring of production related holding times

Key Note: The use of antibiotics in tissue preservation
Mechanisms of action of different antibiotics used in tissue preservation
Detection of microbes in the presence of antibiotics
Antibiotic resistance of persister cells

Implementation of a BSL 4 Laboratory
Ebola epidemic in West Africa
Lessons Learned
The new BSL4 Laboratory in Berlin

An Emerging View of Endotoxin as an IIRMI
Provides a broad biologics-based background from which to understand LER
Review of Bacterial artefacts and mammalian receptors
The key concepts: “IIRMI” , “Detoxification” and “Adjuvant activity”
IIRMI study breakdown and takeaways

Implementation of a new Fogging System
Technical background and mode of operation
Implementation and Validation
Pitfalls and points to consider

Case Studies on Molds
Real life experiences on molds where a bad experience is always an opportunity for
improvement
These case studies are the results of observations made worldwide over the last 2 years
All of them may cause mold contaminations and offer proposals which can be directly applied on daily business

Validation of Gamma Irradiation of Pharmaceutical Products
Principles of gamma irradiation
Regulatory requirements
Dose distribution and dose ratio
Qualification of gamma irradiation processes
Change and risk management

Analysis of species-level resolution with MALDI-TOF Mass Spectrometry and
corresponding performance of 16S rRNA gene sequencing
Evaluation of the relative limits and strengths of MALDI-TOF MS and 16S rRNA gene
sequencing Organisms that cannot be unambiguously resolved to species-level by
routine MALDI-TOF
Corresponding performance of 16S rRNA gene

Detection of P. acnes in Biotech Processes
Problem statement
Development of a growth-based detection assay
Global roll-out

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