Mycoplasma Conference Guide 2014 PDA Europe

The Parenteral Drug Association presents...
2014 PDA Europe
Mycoplasma
Current and Emerging Practices
in Industrial Mycoplasmology
Including the new 2014 PDA Technical Report
on Mycoplasma Filtration
1 October 2014 Training Course
Introduction to Mycoplasma Filtration
29-30 September 2014
Hotel Courtyard Berlin Mitte
Berlin | Germany
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Premium Sponsor:
CONFERENCE 29-30 Sept | EXHIBITION 29-30 Sept | TRAINING COURSE 1 Oct
Conference Guide
Welcome from the Chair
With this year's focus on Industrial Mycoplasmology, we warmly welcome you to Berlin!
We are happy to once again offer you a highly informative and educational forum, highlighting current
mycoplasma methods, concepts and regulation.
Mycoplasma contamination in biopharmaceutical products causes significant financial loss, yet information
about these contamination events is rarely shared and little is known about the issue overall. This workshop aims to encourage transparency, to share and discuss the challenges we face, and work together in
identifying appropriate methods and tools that prevent mycoplasma-contaminated products.
Several industry representatives will present how they won approval from the FDA CDER, CBER, and the
EMA for using NAT methods to detect mycoplasmas in biopharmaceutical products, and a regulatory representative of the German Paul-Ehrlich-Institute will outline how the WHO International Standard (IS) for
mycoplasma NAT was developed and approved. A discussion will follow about how the IS can be used in
validation studies using NAT methods.
Specifically, mycoplasma filtration will be discussed in detail, both from a regulatory and vendor perspective. Regulatory speakers from FDA and EDQM will provide information about what is required for
mycoplasma filtration validation or verification, and an update about the EDQM mycoplasma reference
preparations recommended in the EP guidance for mycoplasma testing by the conventional culture
method will be given. A user perspective and other emerging mycoplasma filtration technologies from
multiple filter manufacturers will be preceded by a presentation about a new publication on a consensus
method for mycoplasma filtration, the PDA Mycoplasma Filtration Technical Report.
In addition, raw material manufacturers for peptones and sera will share how they reduce the risk of
mycoplasma contamination in their products.
Finally, mycoplasma experts will address hot topics that include emerging mycoplasma issues relevant
for mycoplasma detection, prevention and control that may also be important in the field of Advanced
Therapy Medicinal Products. New data will be presented about “non-cultivable” mycoplasmas such as
hemoplasmas, phytoplasmas and cultivar α strains, and how to detect them.
The conference will be complemented by a poster session, a vendor exhibition, and a Training Course on
Mycoplasma Filtration, with leading experts in the field sharing their insights, methods and technological
advances.
We have compiled a program that will provide you with the latest information on Mycoplasma, and we
look forward to a fruitful meeting and many exciting discussions on this highly specialized topic.
Welcome!
Barbara J. Potts, Ph.D. Chair, Potts & Nelson Consulting
Information
PDA Contact
Event Registration
Antje Petzholdt
Registration & Membership Management
[email protected]
Membership Management
Interest Group
General Event Information
Call for Papers
Sylvia Becker
Program Coordinator
[email protected]
Presentations
Speaker Biographies
Event Agenda
Committee Information
Creixell Espilla-Gilart
Exhibition & Sponsorship
Management
[email protected]
Exhibition Information
Sponsoring Opportunities
Scientific Planning Committee
Barbara Potts, Chair, Potts and Nelson Consulting
Thomas Hämmerle, Baxter
Gerhard Haake, Sartorius-Stedim Biotech
Micha Nübling, Paul-Ehrlich-Institute
Renate Rosengarten, Mycoplasma Biosafety Services
Georg Roessling, PDA Europe
Sylvia Becker, PDA Europe
Venue
Courtyard Berlin Mitte
Axel-Springer-Straße 55
10117 Berlin
Germany
Tel.: +49 (0) 30 800 928 0
Fax: 49-30-8009281000
www.marriott.de/hotels/travel/bermt-courtyard-berlincity-center/
Keyvisual on Title
Special Thanks to Prof. Renate Rosengarten, DVM, Ph.D.
Mycoplasma Biosafety Services GmbH
BioTech Center Muthgasse | Muthgasse 11/2
1190 Vienna | Austria
2014 PDA Europe
Parenterals
18-19 February 2014
Berlin | Germany
4-5 November 2014
Munich | Germany
CONFERENCE 4-5 Nov | EXHIBITION 4-5 Nov | TRAINING COURSES 6-7 Nov
europe.pda.org/Parenterals2014
https://europe.pda.org/Myco2014
3
Agenda
Monday, 29 September 2014
9:00
Welcome and Introduction
Session 1: Regulatory Update
Georg Roessling, PDA Europe
Barbara Potts, Conference Chair
Moderator:
Oliver Karo
Regulatory expectations for safety and efficacy of biological medicines include a thorough characterization of laboratory methods applied. The validation of methods for the detection of contaminants is an important prerequisite
for their acceptance. International reference preparations facilitate the comparability of validation exercises. The
new WHO International Standard for Mycoplasma DNA will support the comparative characterization of nucleic acid
amplification techniques of generic design applied for detection of mycoplasma contaminations.
9:15
Method Validation
Vinayak Pawar, FDA
9:45
WHO International Standard
Micha Nübling, Paul-Ehrlich-Institute
10:15
Mycoplasma Testing in the European Pharmacopoeia
Catherine Milne, EDQM
10:45
Q & A, Panel Discussion with Regulators
11:15
Coffee Break & Exhibition
11:45
Anonymous Audience Survey & Discussion:
Industry Practices Regarding Mycoplasma Control
Session 2:
PDA Technical Report on Mycoplasma Filtration
Barbara Potts, Consultant
Christine Wright, EMD Millipore
Moderator:
Thomas Hämmerle
PDA publishes a series of reports covering topics relevant to the pharmaceutical industry and stakeholders. One of
them will be the long awaited PDA Technical Report about Mycoplasma Filtration. There are two presentations giving a
preview, starting with an overview about the report, including the challenges regarding filtration of Mycoplasma.
12:30
Preview of the Upcoming Technical Report on Mycoplasma Filtration
Barbara Potts, Consultant
13:00
Overview of the Paper Published in the PDA Journal
Gerhard Haake, Sartorius-Stedim
13:30
Lunch Break & Exhibition
Session 3:
Raw Materials
Moderator:
Barbara Potts
Mycoplasma contamination in the Biopharmaceutical industry causes significant financial loss and to date most contaminations are caused by large volume raw materials such as serum or peptones. Speakers during this session will address
the controls in place to control mycoplasma contamination and the problems with these controls. Also a speaker will
outline how the control of mycoplasma is integrated into the broader control of all adventitious agents in raw materials.
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14:30
Serum and Safe Use - The Supplier's View
15:00
Panel Discussion
15:30
Coffee Break & Exhibition
https://europe.pda.org/Myco2014
Rosemary Versteegen, International Serum Industry
Association
Agenda
Session 4:
PCR Assays
Moderator:
Thomas Hämmerle
There is quite a lot of information about PCR based Mycoplasma testing in general. However, there is still little information about the implementation of PCR based Mycoplasma testing for lot release, especially regarding potential pitfalls
and issues and means to avoid them. Based on vast knowledge in PCR based Mycoplasma testing regarding technical
and regulatory aspects, this session will feature presentations of methods that received FDA and/or EMA approval.
16:00
Nucleic Acid-Based Rapid Detection of Mycoplasma for
Lot Release Testing
Martina Kopp, Amgen
16:30
Successful mycoTOOL Application to FDA
Sven Deutschmann, Roche
17:00
Q&A, Discussion
17:30
End of Day 1 & Networking Reception in the Exhibition Area
Tuesday, 30 September 2014
Session 5:
Validation of Rapid Mycoplasma Detection Methods
Moderator:
Barbara Potts
A major challenge for Biotechnology companies and for Regulatory Agencies is how to standardize the assays in regard
to colony forming units (CFU), genomic copy and CFU/ml when developing NAT methods to detect mycoplasma. An
International Standard (IS) has been established by the World Health Organization for NAT detection of mycoplasma to
address this significant issue. A representative of the German Paul-Ehrlich-Institute will outline how the WHO IS for mycoplasma NAT was developed and approved. A discussion will follow about how the IS can be used in validation studies
using NAT methods.
9:00
WHO IS in Validations
Micha Nübling, Paul-Ehrlich-Institute
9:20
User’s Perspective on the WHO IS in Validations
Sven Deutschmann, Roche
9:50
Efficient Mycoplasma Concentration Technique for
Increasing Real-Time PCR Sensitivity in Large Sample Volumes
Dirk Vollenbroich, Minerva Analytix
10:20
Validation Strategies for
Real Time qPCR-based Mycoplasma Detection Assays
Michael Brewer, Thermo Fisher Scientific
10:50
Q & A, Discussion
11:15
Coffee Break & Exhibition
Session 6:
Filtration
Moderator:
Gerhard Haake
Mycoplasma contamination in biopharmaceutical products causes significant costs. In the biopharmaceutical industry,
an effective filtration of Mycoplasma is needed for large scale mammalian and bacterial cell culture media. In this
session, the importance of direct flow filters to reduce the risk of a Mycoplasma contamination will be demonstrated.
Important aspects for process qualification of 0.1 µm rated filters will be presented, and a poster session will provide a
solid base for discussion and exchange of these topics.
11:45
Cell Culture Media Sterility:
Key Considerations when Selecting Direct Flow Mycoplasma Filters
Tom Watson, Pall Life Sciences
12:15
Mycoplasma Retentive Filtration:
Important Aspects for Process Qualification of 0.1 µm Rated Filters
Volkmar Thom, Sartorius-Stedim
12:45
Barrier and Beyond:
What Does it Take to Protect the Bioreactor from Virus?
Damon R. Asher, EMD Millipore
13:15
Q & A, Discussion
13:45
Lunch Break & Exhibition
https://europe.pda.org/Myco2014
5
Agenda
Session 7:
Hot Topics in Industrial Mycoplasmology
Moderator:
Renate Rosengarten
This Session will review the newest developments in the field of Industrial Mycoplasmology. The two presentations
given by mycoplasma experts will particularly address recent advances in the detection, prevention and control of
mycoplasmas that are considered “non-cultivable”: the highly fastidious cell culture-adapted cultivar α strains, the
haemoplasmas - a novel group of mycoplasmas within the genus Mycoplasma that are found on and in red blood
cells - and finally, the phytoplasmas that infect plants and are also found in insects.
14:45
Emerging Issues in Industrial Mycoplasmology – An Overview
Renate Rosengarten, Mycoplasma Biosafety Services
15:15
“Non-Cultivable” Mycoplasmas and Their Detection:
Haemoplasmas, Phytoplasmas and Cultivar α Strains
Helena Windsor, Mycoplasma Experience
Session 8:
Advanced Therapy Medicinal Products (ATMPs)
15:45
Mycoplasma Control of Advanced Therapy Medicinal Products –
A Regulator´s View
16:15
Panel Discussion with Regulators of Sessions 1 and 8
17:00
Closing Comments & Farewell Coffee
Moderator:
Jill Mariano
Oliver Karo, Paul-Ehrlich-Institute
Georg Roessling, PDA Europe
The Parenteral Drug Association presents...
2014 PDA Europe
Outsourcing/
Contract Manufacturing
4 December 2014
One-Day Training Course
Managing Outsourced Operations
2-3 December 2014
Hilton Hotel
Berlin | Germany
CONFERENCE 2-3 Dec | E XHIBI T ION 2-3 Dec | T R AINING COUR SE 4 Dec
https://europe.pda.org/Outcon2014
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https://europe.pda.org/Myco2014
Scientific Planning Committee Members
Conference Chair
Barbara Potts, Ph.D., Potts & Nelson Consulting
Dr. Potts specializes in the control of adventitious agents (viruses, mycoplasma and prions) from
a compliance, science and business focus. Her previous experience includes directing scientific and
compliance activities for microbiology, raw materials, virology, mycoplasma, potency, environmental monitoring, cell bank testing for adventitious agents, TSE control in raw materials, nucleic acid
method development and strategic planning for new technologies for the detection of mycoplasma and viruses. She
has work experience with the USDA, ARS, the NIH (NIAID and NINCDS), the University of MN School of Veterinary
Medicine and three biotechnology companies. Her Ph.D. research was focused on the characterization of a new virus
that caused congenital defects in the CNS of fetal lambs as a model for virus infections in humans.
Gerhard Haake, Sartorius Stedim Biotech GmbH
Gerhard Haake was born in Lüdenscheid, Germany. He studied at the University of Applied Science
in Münster/ Germany and has a degree in Ecotrophology. After his studies, he started working in
the Quality Assurance section at Sartorius Stedim Biotech GmbH as a Laboratory Manager of the
Microbiological Laboratory. Since 2011, he has been working in the PDA Mycoplasma Filtration Group
for the upcoming Mycoplasma Filtration Technical Report. In addition, he is an ISO delegate for water
microbiology and a member of some national committees for microbiological issues.
Thomas Hämmerle, Ph.D., Baxter
Following basic training in Biology and a postdoctoral fellowship at SUNY Stony Brook, Thomas joined
Immuno AG, which is now part of Baxter, and is currently heading the Department of Molecularbiological Control at the Baxter site in Orth/ Danube, Austria. Thomas’s expertise relates to the fields
of molecular biology, virology, biochemistry and cell biology. Thomas is author and co-author of more
than twenty peer reviewed papers, book chapters and patents. He is a member of the EDQM Mycoplasma and CTP working parties, member of the USP Residual DNA working party and co-chair of the PDA Mycoplasma Task Force Testing Subgroup. In addition, Thomas is speaker at numerous conferences dealing with current
topics relevant for the biopharmaceutical industry.
Micha Nübling, Ph.D., Paul-Ehrlich-Institute
Graduating from Freiburg University, Dr. M. Nübling joined the Paul-Ehrlich-Institute (PEI) as Molecular Biologist in the 90s. He started at PEI with the testing and approval of in-vitro diagnostics (IVD) in
Germany. Later, as head of the “Molecular Virology” department, M. Nübling focused on the evaluation of nucleic acid amplifications techniques (NAT) for the safety testing of biologicals. In this role, he
performed several research projects and also joined the WHO Collaborating Center for IVD, leading
several WHO standardization projects. He was involved in the introduction of NAT testing for blood products in Germany and Europe and is a member of several EMA and EDQM working groups.
Renate Rosengarten, Ph.D., Mycoplasma Biosafety Services
Renate Rosengarten’s academic career has been marked by a continuous interest in the infection
biology of mycoplasmas for more than 35 years. Her passion for mycoplasmas took her to the
School of Veterinary Medicine Hannover, the University of Missouri-Columbia and the Hadassah
Medical School of the Hebrew University in Jerusalem. Since 1996, Renate Rosengarten has been
Professor of Bacteriology and Hygiene at the University of Veterinary Medicine Vienna in Austria.
She was head of the Institute of Bacteriology, Mycology and Hygiene for more than 17 years, was founder and managing director of the former Mycosafe Diagnostics GmbH, and is currently CSO and COO of the newly established
biosafety company Mycoplasma Biosafety Services GmbH which was founded in December 2013 at her initiative and
with her support. Renate Rosengarten is author of over 100 publications on mycoplasmas in peer-reviewed scientific
journals and books.
https://europe.pda.org/Myco2014
7
Speaker / Moderator Biographies
Damon R. Asher, Ph.D., EMD Millipore
Damon Asher is currently engaged in numerous biosafety and process monitoring initiatives, including novel viral and bacterial clearance and detection technologies. He is the lead scientist for EMD
Millipore’s project to develop highly purified virus preparations for use in virus spiking studies, and
has served as an author of PDA technical reports on virus spike preparation and virus filtration. He
is currently focused on the creation of integrated solutions for protection of the bioreactor from viral
and bacterial contamination. Damon holds a Ph.D. in Immunology from Harvard University and a Master’s Degree in
Biomedical Sciences from Harvard Medical School.
Michael Brewer, Thermo Fisher Scientific
Michael Brewer is the Head of Pharmaceutical Analytics at Thermo Fisher Scientific, leading the
team responsible for product applications including Microbiology, Analytical Sciences and Quality
control. The products are fully integrated, molecular solutions for Bacterial and Fungal identification,
Mycoplasma and Viral detection and host cell DNA and protein quantitation. Michael has over 30
years’ experience in the Biopharma industry, including, Scios, Synergen and Amgen in a variety of
roles including Discovery Research, Analytical Sciences and Quality Control. Prior to joining Thermo Fisher Scientific,
he lead a group at Amgen that developed qualified, validated and implemented molecular methods for host cell DNA
quantitation, contaminant (Mycoplasma, Virus and Bacteria) detection, contaminant identification, strain typing and
genotypic verification of production cell lines.
Sven Deutschmann, Roche
Sven M. Deutschmann studied biology (major: microbiology, biochemistry and biotechnology) at the
University of Brunswick where he obtained his Ph.D. in cell culture technology. In 1995 he joined
Roche Diagnostics GmbH as Manager QC. In the past years he took over increasing local and global
responsibilities and accountabilities within the Roche / Genentech Biologics QC Network as well as in
the field of External Interaction. Currently, Sven Deutschmann is responsible for the microbiological,
molecular and cell biological analytics of QC- and In-Process-Control-samples in the production of biotechnological
derived commercial and clinical active pharmaceutical ingredients. Beginning of 2012 he was appointed as Global Head
of a Corporate Function called “Method Management and Technology” within the Biologics Operational Unit of Roche
/ Genentech with special focus on PCR- / NAT-based technologies and Rapid Microbiological Methods. In addition, he
is member of the PDA “Mycoplasma Task Force” and chairman of the Advisory Board of the ECA “Rapid Microbiological
Methods Working Group”.
Oliver Karo, Paul-Ehrlich-Institute
Oliver studied Biology at the Technical University in Darmstadt with focus on Microbiology. Since
2009, he has been working at the Paul-Ehrlich-Institute in the Division Microbial Safety. He is a quality assessor and a national expert advisor for the microbial safety of advanced therapy medicinal
products (ATMPs) and member of the “Cell Therapy Products” Working Party of the German Pharmacopoeia Commission.
Martina Kopp, Ph.D., Amgen
Martina Kopp received her Ph.D. in molecular virology from the Friedrich-Löffler-Institut, the Federal
Research Institute for Animal Health in Germany, in 2004. She continued her work in the virology
field by completing a post-doctoral fellowship at the Center of Hepatitis C Research at the Rockefeller University in New York. Martina Kopp joined the Biosafety Development Group at Amgen in
2011 where she focuses on the risk mitigation of adventitious contaminations in manufacturing processes, the detection and identification of such contaminants as well as the viral clearance assessment for products
produced in mammalian cell culture.
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https://europe.pda.org/Myco2014
Speaker / Moderator Biographies
Jill Mariano, MD., Vice President, Bionique Testing Laboratories
Jill Mariano, MD, received her Doctor of Medicine degree from Hahnemann University School of
Medicine in Philadelphia, PA. She joined Bionique in 2008. In the capacity of Vice President, she is in
charge of leading collaborative efforts in the development and implementation of Bionique’s overall
strategic plan. Dr. Mariano is currently a member of the PDA Mycoplasma Task Force and served on
the subcommittee of Alternative Methods for Mycoplasma Testing.
Catherine Milne, Ph.D., EDQM
Catherine Milne received her Ph.D. from the University of Toronto, Department of Molecular and
Medical Genetics in 1994. From 1994 to 1999 she was a post-doctoral fellow at the Medical
Research Council, Laboratory of Molecular Biology in Cambridge, England. In 1999 she joined the
Council of Europe, European Directorate for the Quality of Medicines and HealthCare (EDQM), where
she is the scientific officer responsible for the Networks of Official Medicines Control Laboratories
(OMCLs) involved in Official Control Authority Batch Release (OCABR) of human vaccines, medicinal products derived
from human blood and plasma, and veterinary vaccines respectively. She is also involved in the EDQM Biological
Standardisation Programme (BSP) and has coordinated a number of projects for the standardisation of methods and
reference materials for the evaluation of biologicals in that context. BSP projects have included the establishment
of Ph Eur reference preparations for mycoplasma and method and reference development for various human and
veterinary vaccines and medicinal products derived from human blood and plasma.
Vinayak Pawar, Ph.D., FDA
Vinayak is a Senior Regulatory Review Microbiologist with the Office of Pharmaceutical Sciences,
CDER, FDA where he serves as a Regulatory, Scientific and Technical consultant providing guidance
to industry regarding CDER & CBER cGMP issues and performs risk based quality assessment of the
manufacturing and control information submitted in IND, NDA, DMF and post-approval NDA supplements. He serves on FDA Guidance and Technical Committees and trains Pharmaceutical Inspectorate Candidates when required. He received post baccalaureate Medical Technology training and certification at St.
Francis Hospital in Peoria, IL and a Master’s Degree in Food Technology from the University of Missouri, Columbia, MI.
He earned a Ph.D. degree in Microbiology from University of Kentucky, Lexington, KY. Previously, as a Senior Director
at Parkedale Pharmaceuticals & BioReliance Inc. he directed day-to-day QA/QC operations and regulatory affairs
while enforcing company-wide cGMP compliance for aseptic filling operations. Prior to serving in the pharmaceutical industry he was the Chairman of the Clinical Laboratory Sciences Department at University of Nevada and the
Director of Graduate Medical Technology Program at University of Maryland, School of Medicine. While at FDA he
has served on PDA TR 26 Task Force Committee (2008) and currently serves on PDA Mycoplasma Filtration TR Task
Force Committee and the PDA Mycoplasma Task Force Filtration Subcommittee.
Volkmar Thom, Ph.D., Sartorius-Stedim
Volkmar Thom is a Process Engineer by training and received his Ph.D. in Chemical Engineering from
the Technical University of Denmark in the area of Membrane Science. After his Post Doc at the Risǿ
National Laboratory in Denmark, he switched to industry and held several positions as a membrane
scientist at Millipore Corp., since 2003 at Sartorius Stedim Biotech GmbH. Since 2006, he and his
R&D group have been responsible for the development and implementation of all synthetic membranes and their respective surface modification at Sartorius Stedim Biotech.
https://europe.pda.org/Myco2014
9
Speaker / Moderator Biographies
Rosemary Versteegen, Ph.D., International Serum Industry Association
Dr. Versteegen received her B.Sc. and Ph.D. degrees in Biochemistry from Glasgow University, Scotland. She held Postdoctoral scholarships at Cambridge University, England and the National Institutes of Health working in areas of disease research. Following several years in NIH sponsored cancer research programs, she joined Life Technologies and held various key roles, both technical and
business oriented, including Vice President of the GIBCO Manufacturing Facility, Vice President of
Regulatory Affairs, Vice President of New Business Development and Vice President of Strategic Planning. In 2000,
Dr Versteegen became a founding partner of the Lifia Group, a consulting organization focused on helping life
science and biotechnology companies grow through clearly enunciated, actionable strategic plans. Since its inception
in 2006, Dr. Versteegen has been the CEO of the International Serum Industry Association, a global life science notfor-profit association. The mission of the association is to establish, promote and assure compliance with uncompromised standards of excellence and ethics in the business practices of the global animal serum and animal derived
products supply industry. The primary focus is on safety and safe use of serum and animal derived products through
proper origin traceability, truth in labelling, and appropriate standardization and oversight.
Dirk Vollenbroich, Ph.D., Minerva Analytix
Dirk Vollenbroich started his career as an engineer for biotechnology with a research focus on
peptide antibiotic pathways at the University of Applied Sciences (Berlin, Germany) and acquired
a doctorate in biochemistry from the Technical University of Berlin (Germany) for the discovery of
novel antibiotic properties of secondary metabolites. At the German Federal Institute for Health,
he gained invaluable experience within the field of virus safety of blood products, virus inactivation
in biopharmaceutical processes and mycoplasma contamination control of cell-culture-derived materials. Molecular
diagnostics and bacterial genomics were of primary interest during his research work at the Louisiana State University Medical Center (USA). In 1999, he founded Minerva Biolabs GmbH, providing products and services for safety
and pathogen detection to biopharmaceutical companies and research facilities worldwide. In 2013, he supervised
the service department outsourced to Minerva Analytix GmbH and became senior adviser of the company in 2014.
Tom Watson, Pall Life Sciences
Tom joined Pall in 2003, having graduated from the University of Sheffield, UK with a degree in Biotechnology and Microbiology. Following several years as an Account Manager, in 2010 he joined the
Global Product Marketing team to take up his current position as Global Product Manager, Sterilizing-grade Filters. Working closely with Pall R&D, Tom’s key focus is the development and introduction of sterilizing-grade filter products designed for use in biopharmaceutical manufacturing.
Helena Windsor, Mycoplasma Experience
Helena joined the Wellcome Research laboratories in Beckenham UK from school in 1972 and gained
a degree in Applied Biology in 1979. From 1974 to 1985 she worked in the Mycoplasma Section at
Wellcome, testing vaccines and cell cultures and assisting in the development of media to grow fastidious strains and species, including the cultivar alpha strains of M.hyorhinis. Mycoplasma Experience was established in 1988 by David and Helena to offer a range of services in mycoplasmology.
Helena has taken over the running of the company from David and continues to promote mollicute culture. Research
at Mycoplasma Experience focuses on the continuing effort to culture the “unculturable”.
Christine Wright, Ph.D., EMD Millipore
Christine Wright received her Ph.D. in Microbiology from the University of New Hampshire. She is
currently a Research Scientist with EMD Millipore focused on sterilizing filtration validation, single
use systems validation and integrity testing for sterile filtration, single-use systems and sterile connectors.
10 https://europe.pda.org/Myco2014
One-Day Training Course
Introduction to
Mycoplasma Filtration
Moderator: Martha Folmsbee, Pall Life Sciences
Course Objectives
The objectives of the training are to educate filter users about how filters are evaluated,
what their risks are with regards to mycoplasma contamination and what filtration
can do for them as a mycoplasma control step.
Attendees will learn about sterile filtration, how sterile filters are rated and evaluated,
and how to apply that knowledge to mycoplasma and mycoplasma filtration as a part
of the contamination control routine.
Wednesday, 1 October 2014
9:00 -17:00
9:00
Welcome and Introduction
Georg Roessling, PDA Europe
9:15
General Filtration Introduction
With a focus on sterilizing grade filtration
Martha Folmsbee, Pall Life Sciences
10:15
Coffee Break
10:30
Integrity Testing
Randy Wilkins, EMD Millipore
Magnus Stering, Sartorius-Stedim
11:30
Regulations around Sterile Filtration
Vinayak Pawar, FDA
12:00
Lunch Break
13:00
A Basic Microbiological Introduction to Mycoplasma and
Bacteria, and How They Differ
Barbara Potts, Potts & Nelson Consulting
14:00
Common Sources of Mycoplasma Contamination
Helena Windsor, Mycoplasma Experience
14:30
Lessons Learned from an Acholeplasma Laidlawii
Contamination in a Biotech Cell Culture Facility
Hans Noordergraaf, Abbott
15:00
Coffee Break
15:30
Mycoplasma Filtration
Martha Folmsbee, Pall Life Sciences
16:30
Q&A, Panel Discussion with Moderators
Martha Folmsbee, Pall Life Sciences
Gerhard Haake, Sartorius-Stedim
Barbara Potts, Potts & Nelson Consulting
17:00
End of the Course
https://europe.pda.org/Myco2014
11
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https://europe.pda.org/Myco2014
13
Exhibitor Abstracts
Greiner Bio-One GmbH
Maybachstr. 2
72636 Frickenhausen
Germany
Phone: +49 7022 94 80
Fax: +49 7022 94 85 14
[email protected]
www.gbo.com
Minerva Analytix GmbH
Köpenicker Str. 325
12555 Berlin
Germany
Tel: +49 30 20 00 43 75 0
Fax: +49 30 20 00 43 75 1
[email protected]
www.minerva-analytix.com
Greiner Bio-One Diagnostics is a business unit of Greiner
Bio-One. Our business focus is the molecular diagnostics of
infectious diseases. Our products are distributed worldwide
through a specialised sales force and our international dealer
network. Our key products are in the fields of a) sexually
transmitted infectious diseases (STDs), b) healthcare associated infections (HAIs) and c) products for vaccine safety. We
offer our customers complete solutions, from sample withdraw to digital result administration. With our technologies,
we cover the high-throughput screening diagnostic market
as well as bedside, individualised and easy to use rapid
diagnostics for hospitals and medical practices.
Minerva Analytix GmbH is a leading analytical, GMP certified service lab for the control of microbial contamination.
The company is based in Berlin. The core competence lies
in the control of mycoplasma, bacteria and viruses in cell
cultures and biopharmaceuticals. The Team of Minerva Analytix includes only high qualifield and trained persons with a
deeply understanding of quality and customer satisfaction.
The Lab provides specialized service for Research & Development, ATMPs, Pharmaceutical Industries and Media Manufacturer and is readily and economically available worldwide.
Life Technologies GmbH
Frankfurter Str. 129b
64293 Darmstadt
Germany
Tel: +49 6151 9670 0
Fax: +49 6151 9670 5259
[email protected]
www.lifetechnologies.com
Life Technologies™ products harness the power of science
to transform lives. As a member of the Thermo Fisher Scientific family of brands, our instruments, everyday tools, and
services offer high-quality, innovative life science solutions
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learn more.
14 https://europe.pda.org/Myco2014
Sartorius Stedim Biotech GmbH
August Spindler-Str. 11
37079 Göttingen
Germany
Tel: +49 551 30 80
Fax: +49 551 30 83 28 9
[email protected]
www.sartorius.de
PREMIUM SPONSOR
Sartorius is one of the world's leading providers of laboratory and process technologies and equipment. The Lab
Products & Services Division is a premium supplier of highquality laboratory instruments, high-grade consumables and
excellent services. Our customers are from the pharmaceutical, chemical and food industries as well as from the academic sector. The product portfolio focuses on high-value
laboratory instruments, such as lab balances, pipettes and
laboratory water purification systems. Moreover, we offer
the widest range of consumables, such as laboratory filters
and pipette tips.
S ONNENHOF
PDA Europe supports the children's hospice „Sonnenhof”
The Sonnenhof Hospice, located near PDA’s office in Berlin, offers support
and assistance to families with children suffering from incurable and/or
debilitating diseases.
At Sonnenhof, children, together with their families, can spend the time they
have left as they wish and find some relief from their suffering.
Instead of purchasing expensive gifts for the conference speakers, PDA has
decided to donate this amount to the Sonnenhof Hospice. You can also conS ONNENHOF
tribute
and help us increase the amount, it is easy: buy a package of chewing
gums at the registration desk. THANK YOU!
To know more about the Sonnenhof Hospice,
please visit www.bjoern-schulz-stiftung.de
MYCOPLASMA AND VIRUS
TESTING SERVICES
FOR BIOLOGICALS
S ONNENHOF
Contamination of cell cultures with mycoplasmas or viruses can occur in manifold ways regardless the safety standards of the lab. It is important to check cultures in research, development
and routine production frequently to minimize the impact of an undetected contamination.
In pharmaceutical industry mycoplasma testing is a strictly regulated aspect in product manufacturing. Minerva Analytix offers an expert and reliable service with a broad range of testing procedures
for cell cultures and other biological materials.
Our testing service for mycoplasmas is based on a European Pharmacopoeia (2.6.7) compliant,
validated Real-Time PCR Test system including a turnaround time (sample to result) of <48h.
The entire service lab is accredited according to DIN EN ISO 17025 and GMP certified. Intensive
audits and long term experiences allow state-of-the-art testing even with complicated sample matrices and for special customer needs. Please contact the Minerva Analytix Team for more detailed
information, or visit our homepage.
Köpenicker Straße 325
D-12555 Berlin
Tel. +49 (0)30 2000 4375-0
Fax +49 (0)30 2000 4375-1
[email protected]
www.minerva-analytix.com
Connecting People,
Science and Regulation®
The Parenteral Drug Association presents:
2015 PDA Europe Conference
Pharmaceutical Microbiology
Current State & Future Focus
18-19 February Conference | Exhibition
https://europe.pda.org/Microbio2015
Mark
Your
Calendar
18-19 February 2015
Hilton Hotel
Berlin | Germany