Ensuring Adventitious Agent Sa fety in Biologics Agenda

1. Ensuring Register
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two-day Conference: 18-19 october 2011
HEAr froM 20 industry
ExPErts inCluding:
thomas r. Kreil, Ph.d.
associate Professor of virology
Pre-Conference focus day: 17 october 2011 senior director viral vaccines
nH München dornach, Munich, germany & global Pathogen safety
Baxter Bioscience
creating effective strategies to mitigate risk Jens-Peter gregersen,
and enable prompt remediation of viral, prion sme virology, virus safety,
new Projects R&d, novartis
and mycoplasma contamination vaccines and diagnostics
Walter de Matteo,
CoME AWAy WitH frEsH idEAs on:
w w w. a d v e n t i t ious a g e n t se v e n t. c o m
microbiological laboratory
manager, Quality control, iBsA
implementing the latest techniques to screen institut Biochimique sA
for mycoplasma and mitigate your risk of Marc Martin, viral safety
contamination with roche assessor, AfssAPs
Marie Murphy,
Performing risk assessments to avoid tse microbiologist, Eli lilly
contamination at your facility with AfssAPs Hans nitschko, doctor of
creating a contingency plan for remediation diagnostic virology, max von
Pettenkofer institute,
in case of contamination at your facility with university of Munich
Eli lilly tanja opriessnig,
associate Professor, department
Best-practice approaches to dealing with actual of veterinary diagnostic and
contaminations from genzyme and Merrimack Production animal medicine,
– apply their lessons to your organisation veterinary diagnostic laboratory -
iowa state university
ensuring the safety of your raw materials with Barbara Potts, senior
Csl Behring – get that vital first step right! consultant, Potts and nelson
Consulting, llC, chair,
mycoplasma task Force, PdA
don’t Miss spotlight on prevention
our in-dEPtH strategies (not just after- fazal Khan, senior vice
MyCoPlAsMA President of manufacturing,
the-fact containment) Contamination
Merrimack
foCus dAy! Conqueror!
speakers include Roche’s Albrecht gröner, Head of
Holger Kavermann Full-length Pathogen safety, Csl Behring
and Merck Serono’s mycoplasma Holger Kavermann,
Emiliano Toso. manager Qc, roche
see page 3 for details.
focus day
Emiliano toso,
molecular Biology lab Head,
Well selected speakers, 2 real-world Merck serono
good overview and case contamination case Contamination nathan Jones, senior
studies on viral safety. Conqueror!
studies scientist, genzyme
virusure gmbH sebastien Carayol,
manager of scientific Bioprocess
good spread of talks- Interactive R&d, downstream Process,
important key speakers. discussions and sanofi Pasteur
networking …And MAny MorE!
sanofi-Aventis
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2. Advisory BoArd
thanks to our advisory board for lending their expert advice; their feedback and suggestions have been instrumental
in helping to shape our programme!
Mark Plavsic, senior director of corporate dayue Chen, Research advisor, Eli lilly
Biosafety, genzyme
Hans rogl, manager development Recovery &
thomas r. Kreil, Ph.d., associate Professor of downstream Processing, roche diagnostics
virology, senior director, viral vaccines & global
Pathogen safety, Baxter Bioscience Barbara Potts, senior consultant, Potts and
nelson Consulting, llC, chair, mycoplasma task
James robertson, Principal scientist, virology, Force, PdA
niBsC
your ExPErt sPEAKEr fACulty
Hans noordergraaf, microbiological specialist, Qc fazal Khan, senior vice President of manufacturing,
microbiology, Abbott Biologicals B.v. Merrimack Pharmaceuticals
Marc Martin, viral safety assessor, AfssAPs Emiliano toso, molecular Biology lab Head, Merck
serono
thomas r. Kreil, Ph.d., associate Professor of
virology, senior director viral vaccines & global rebecca sheets, vaccine scientific and Regulatory
Pathogen safety, Baxter Bioscience specialist, niH/niAid (pending official approval)
Albrecht gröner, Head of Pathogen safety, Csl Jens-Peter gregersen, sme virology, virus
Behring safety, new Projects R&d, novartis vaccines and
diagnostics
Marie Murphy, microbiologist, Eli lilly
Jürgen Hubert Blusch, Head cell line and
santosh nanda, microbiologist/Primary Reviewer, adventitious agents analytics, novartis Ag
cBeR, fdA (pending offical approval)
Kristin Murray, senior manager gcmc Regulatory,
nathan Jones, senior scientist, genzyme Pfizer
Walter de Matteo, microbiological laboratory steven reich, Risk management Principal, global
manager, Quality control, iBsA institut Quality, Pfizer
Biochimique sA
Barbara Potts, senior consultant, Potts and
rosa Anna siciliano, Proteomic and Biomolecular nelson Consulting, llc, chair, mycoplasma task
mass spectrometry center, institute of Food science, Force, PdA
italian national research Council (Cnr)
Holger Kavermann, manager Qc, roche
tanja opriessnig, associate Professor, department
of veterinary diagnostic and Production animal sebastien Carayol, manager of scientific
medicine, veterinary diagnostic laboratory - iowa Bioprocess R&d, downstream Process, sanofi
state university Pasteur
Jürgen A. richt, director, dHs center of excellence Hans nitschko, doctor of diagnostic virology, max
for emerging and Zoonotic animal diseases (ceeZad), von Pettenkofer institute, university of Munich
Kansas state university
w w w. adventitiousagentse vent.com
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3. PrE-ConfErEnCE foCus dAy 17 OCTOBER 2011
MyCOplasMa MiTigaTiOn
08.30 Coffee and Registration
09.00 Chair’s Opening Remarks and Pharma IQ Welcome
09.10 Performing Risk Mitigation on Animal- and Plant-Based Raw Materials to Avoid Mycoplasma Contamination
• sourcing your raw materials from a trusted supplier (and understanding what screenings your supplier uses)
• Subjecting all animal- or plant-based raw materials to testing before proceeding with production
• Determining the detection limits of various mycoplasma screening methods
• Evaluating which detection methods are most appropriate for which material
Hans Noordergraaf, Microbiological Specialist, QC Microbiology, Abbott Biologicals B.v.
09.50 Networking Coffee Break
WorKsHoP A
10.20 Debunking the Myths of Mycoplasmology as Addressed in the Parenteral Drug Association’s Technical Report No. 50
attend this session to:
• Review common assumptions about mycoplasma – find out which are true and which are false
• Assess the International Standard for PCR testing and mycoplasma filtration she helped
• Evaluate new testing methods for applicability develop a key
PCr kit
• Discuss regulatory expectations from the EU and US
Barbara Potts, Senior Consultant, Potts and nelson Consulting, llC, Chair, Mycoplasma Task Force, PdA
12.20 Networking Lunch Break
WorKsHoP B
13.30 Evaluating Alternative Mycoplasma Testing Methods
attend this session to:
• Examine current mycoplasma testing methods, their strengths and limitations
• Learn about mycoplasma control and rapid detection using quasi real-time solutions and animal-free media components
for optimal safety
• Understand the importance of viral inactivation case studies and implementing complementary technologies to ensure viral safety
• Explore a range of potential detection technologies and identify the utility and shortcomings of each
Emiliano Toso, Molecular Biology Lab Head, Merck serono
15.30 Networking Coffee Break
16.00 PCR vs. Classical Culture Testing for Mycoplasma in Pharmaceutical Production
• Comparing the pros and cons of classical and pCR testing methods His lab released the
commercial PCr kitfirst
• Reducing testing time with PCR without losing sensitivity to contaminants mycoplasma detec for
tion
• Enforcing GMP requirements and validation guidelines for PCR testing
Holger Kavermann, Manager QC, roche
16.40 CRISIS CLINIC: MYCOPLASMA CONTAMINATION AND MITIGATION
This interactive session will provide a forum to create a strategy for managing a hypothetical mycoplasma contamination event
• Exploring the implication of a mycoplasma contamination at a manufacturing plant
• Brainstorming the immediate consequences and a rapid response to mitigate the crisis
• Implementing a plan of action to prevent further contamination
• Working around the potential aftermath and putting in place a roadmap for decontamination and recommencement of production
Emiliano Toso, Molecular Biology Lab Head, Merck serono
17.20 Chair’s Closing Remarks and End of Focus Day
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4. dAy onE 18 OCTOBER 2011 www.adventitiousagentsevent.com
08.30 Coffee and Registration 14.00 Mitigating the Risk of Prion Contamination
• Understanding the causes of BSE
He created
09.00 Chair’s Opening Remarks and Pharma IQ Welcome prion-free
• Creating prion-free “knockout cattle” and evaluating
‘knockout
cattle’
PLANNING AND PREVENTION their uses
• Ensuring the purity of your source materials
09.10 Case Study: Applying Holistic Product Protection
• Proactively creating remediation plans in the event of
Strategies to a Mammalian Multiproduct Facility
contamination
CASE STUDY
• Creating design/segregation strategies for a new
Jürgen A. Richt, Director, DHS Center of Excellence for
multiproduct facility to reduce risk of contamination
Emerging and Zoonotic Animal Diseases (CEEZAD),
• Assessing rapid methods for early contamination detection
Kansas state university
• Proactively creating remediation plans for contamination
Marie Murphy, Microbiologist, Eli lilly 14.40 Investigating Best Methods for Ensuring TSE Safety
• Performing risk assessment for TSE
09.50 Ensuring the Safety of Products and Biologics of
• Understanding guidelines and ensuring regulatory
Porcine Origin – A Veterinarian’s Perspective
compliance
• Zoonotic, potentially zoonotic and miscellaneous
• Performing validation to remove TSE
contaminations in pigs: What should be tested and
Marc Martin, Viral Safety Assessor, AfssAPs
surveyed for?
• “Acceptable” contamination level – does it exist? 15.20 Networking Coffee Break
• Determining presence versus viability or infectivity:
DETECTION AND VALIDATION
What alternatives are there?
• Removal from the product versus removal from the pig: 15.50 Break-Out Roundtable Discussions
Which is the better/safer/more cost-effective choice? Participants will be able to choose one of two roundtables
Tanja Opriessnig, Associate Professor, Department of and discuss the points outlined below
Veterinary Diagnostic and Production Animal Medicine,
Roundtable A: Assessing Novel Analytical Techniques
Veterinary Diagnostic Laboratory, iowa state university
This discussion will survey new analytical methodologies
10.30 Networking Coffee Break such as mathematically parallel/next-generation
sequencing; how do you determine when these intensive,
11.00 Ensuring the Safety of Plasma-Derived Material
expensive technologies are necessary versus when they’re
• Running risk assessment on plasma-derived material
excessive (and will they become routine)?
• Controlling source material from collection through
Moderator: Jürgen Hubert Blusch, Head Cell Line and
manufacturing
Adventitious Agents Analytics, novartis Ag
• Performing virus validation studies to determine the
efficacy of removal methods Roundtable B: Emerging Detection Technologies
• Ascertaining best methods for inactivating viral and Their Applications
contaminants This discussion will focus on available tools as applied in the
Albrecht Gröner, Head of Pathogen Safety, Csl Behring biotech industries for the accurate sensing of viral
ROUNDTABLE
contaminants, and how they can be applied to ultimately
11.40 Speed Networking
virus-proof your bioprocesses
Like Speed Dating, But Without the Pressure to Commit
Moderator: Thomas R. Kreil, Ph.D., Associate Professor
You’ve seen each other across the room…now meet face-to
of Virology, Senior Director Viral Vaccines & Global Pathogen
face. Bring plenty of business cards to exchange in a series
Safety, Baxter Bioscience
of 2-3 minute one-on-one meetings with your fellow
speakers, attendees and vendors. Your mission - learn one of 16.30 How to Maximise the Potential and Avoid the
the following things about each person you meet: Deficiencies of Nucleic Acid Testing (NAT)
• What do you hope to learn from this conference? • identifying when to use naT as opposed to direct
• Which company/speaker are you most interested in microbiological culture testing
hearing from? • Comparing direct NAT and NAT combined with an
• What is your biggest challenge in the adventitious agent enrichment step
safety arena? • Analysing the deficiencies of NAT versus its benefits
• Taking a closer look at sensitivity, specificity and
12.10 Case Study: Learning From Genzyme’s Vesivirus
reproducibility of NAT/PCR testing for optimal virus
Contamination and Instituting New Prevention
safety screening
He helped Strategies
genzyme
recover from Hans Nitschko, Doctor of Diagnostic Virology, Max von
contamination • Helping to understand the offending agent: unraveling the
Pettenkofer Institute, university of Munich
specifics of vesivirus biology
• Elaborating on the advantages and disadvantages of 17.10 Validation of Viral Testing Method for Human-Derived
current in vitro virus testing methods Raw Materials
CASE STUDY
• Outlining the crucial mitigation steps involved in virus • Performing viral analysis on raw materials derived from
proofing your processes human urine
• Highlighting the types of virus clearance methods required • Understanding the need for validation
to ensure maximal defense from contamination • Testing raw materials for HIV, HCV, and HBV
Nathan Jones, Senior Scientist, genzyme • Selecting a validation method and validating in accordance
with ICH guidelines
12.50 Networking Lunch Break
Walter De Matteo, Microbiological Laboratory Manager,
Quality Control, iBsA institut Biochimique sA
17.50 Chair’s Closing Remarks and End of Day One
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5. dAy tWo 19 OCTOBER 2011 www.adventitiousagentsevent.com
08.30 Coffee and Registration • Assessing the risks of the cell-based development process
09.00 Chair’s Opening Remarks and Pharma IQ Welcome (for example, which plant virus can be transmitted to humans)
• Creating safety protocols for this new production method
CONTAINMENT AND REMEDIATION
• Investigating the challenges and benefits of utilising cell
9.10 Case Study: How Merrimack Suffered - and Recovered based vaccine development and developing regulatory
From - an MVM Contamination guidance to govern the process
• Detecting the root cause of the MVM (Minute Virus of Santosh Nanda, Microbiologist/Primary Reviewer, CBER,
Mice) contamination official (pending FDA approval)
• Effectively containing the contamination to avoid spread
HIGHLIGHTING NEW TECHNOLOGIES
throughout the facility and into product
CASE STUDY
• Utilising appropriate remediation technologies 14.40 A Risk Assessment Model to Predict the Likelihood
• Formulating prevention strategies to circumvent of Influenza Vaccine Contamination
future contaminations • Creating an effective model to assess the risk of viral
Fazal Khan, Senior Vice President of Manufacturing, contamination of the influenza vaccine
Merrimack Pharmaceuticals • Comparing the likelihood of contamination of egg-based
flu vaccine production with that of cell-based
09.50 Evaluating the Efficacy and Applicability of
vaccine production
Cleanup Methods
His studies • Gauging the basic growth characteristics of each virus,
can help you
clean up your • Surveying available methods for post-contamination cleanup
contamination its ability to grow in different cell substrates and resistance
• Determining which technologies are most effective at
to processing steps during vaccine manufacture
remediating varying types of contamination (e.g., viral,
Jens-Peter Gregersen, SME Virology, Virus Safety, New
mycoplasma, bacterial)
Projects R&D, novartis vaccines and diagnostics
• Optimising facility and process decontamination using
cleaning agents with known virucidal efficacy 15.20 Networking Coffee Break
Jens-Peter Gregersen, SME Virology, Virus Safety, New 15.50 Implementing Nanofiltration for Pathogen Reduction
Projects R&D, novartis vaccines and diagnostics
He’s exploring • Analysing current nanofilters and assessing their potential
the potential of
10.30 Networking Coffee Break
nanofiltration to remove viral contaminants
• Finding the right filtration system for your needs:
11.00 Developing an Effective Viral Clearance Strategy
nanofiltration versus traditional filtration steps
for Vaccines
• Ensuring regulatory compliance in the validation of virus
• Determining an effective purification process for
filters and filtration
virus removal
• Hypothesising future developments in nanofiltration
• Creating a viral clearance strategy and validation
Thomas R. Kreil, Ph.D., Associate Professor of Virology
methodology
Senior Director Viral Vaccines & Global Pathogen Safety,
• Achieving viral vaccine inactivation through standard
Baxter Bioscience
inactivation methods
• Utilising recombinant proteins in viral inactivation 16.30 Utilising MALDI-TOF Mass Spectrometry for Rapid
Sebastien Carayol, Manager of Scientific Bioprocess R&D, Bacterial Identification
Downstream Process, sanofi Pasteur • Understanding the basic principles of MALDI-TOF
mass spectrometry
11.40 Speed Networking
• Creating an analytical strategy based on MALDI-TOF-MS
Like Speed Dating, But Without the Pressure to Commit
for rapid bacterial identification: recent developments in
You’ve seen each other across the room…now meet face-to
protocols, instrumentation and bioinformatic tools.
face. Bring plenty of business cards to exchange in a series
• Using MALDI-TOF-MS in routine microbiological laboratories:
of 2-3 minute one-on-one meetings with your fellow
an overview of recent publications on the topic
speakers, attendees and vendors. Your mission - learn one of
• Evaluation of strengths and weakness of the methodology
the following things about each person you meet:
Rosa Anna Siciliano, proteomic and Biomolecular Mass
• Which contaminant is your greatest bugbear? Prions,
Spectrometry Center, Institute of Food Science, italian
mycoplasma, bacteria – pick your poison!
national research Council (Cnr)
• Which are your preferred testing methods?
• Are there any developments in testing/purification 17.10 Utilising Quality Risk Management (QRM) to Ensure
techniques that you think hold particular promise? Pathogen Safety in Biopharma Manufacturing
• Optimising viral cross-contamination risk management
UNDERSTANDING REGULATIONS AND
in contemporary multi-product and multi-host
ACHIEVING COMPLIANCE
manufacturing facilities
12.10 Systematically Characterising Adventitious Agent • Using QRM to evaluate and mitigate potential viral
Tests for Biologics carryover in equipment shared between different host
• Assessing the breadth and sensitivity of routine cell processes
adventitious agent tests • Use of exploratory risk assessment tools such as Fault Tree
• Harmonising test methods (both existing and emerging) Analysis to comprehensively identify and scope viral
• Discussing the policy perspective on adapting new contamination risks
testing methodologies • Demonstrating viral inactivation capabilities of equipment
Rebecca Sheets, Vaccine Scientific and Regulatory and facility cleaning procedures via Hazards Analysis and
Specialist, niH/niAid (pending official approval) Critical Control Points (HACCP)
12.50 Networking Lunch Break Steven Reich, Risk Management Principal, Global Quality,
14.00 Evaluating the Safety of New Flu Vaccine Development Pfizer
Methods—A Regulatory Perspective Kristin Murray, Senior Manager GCMC Regulatory, Pfizer
• Moving away from egg-based flu vaccine production and 18.00 Close of conference and Chair’s closing remarks
toward faster, cell-based vaccine production
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6. sPonsorsHiP & ExHiBition www.adventitiousagentsevent.com
Maximise your involvement: sponsorship and Exhibition opportunities
The Ensuring Adventitious Agent Safety in Biologics conference will be attended by senior officials and decision-makers
from the biotech, pharma and biopharma industries, bringing buyers and suppliers together in one place.
Focused and high-level, the event will be an excellent platform to initiate new business relationships. With tailored
networking, sponsors can achieve the face-to-face contact that overcrowded trade shows cannot deliver.
Exhibiting and Sponsorship options are extensive and packages can be tailor-made to suit your company's needs.
Packages include complimentary entry passes, targeted marketing to industry officials and executives and bespoke
networking opportunities.
Other features of sponsorship include:
• Prominent exhibition space in the main conference networking area
• Participation in comprehensive pre-event marketing campaigns
• Tailored marketing strategies to suit your organisation’s size, capabilities and individual requirements
For more information and to discuss the right opportunity, contact Yaw Asamani on
+44 (0)207 368 9300 or yaw.asamani@iqpc.co.uk
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Exp. Date: 6 6 6 6 Sec: 6 6 6 6
rescheduled date, you will receive a credit for 100% of the contract fee paid. You may use this credit
for another IQPC event to be mutually agreed with IQPC, which must occur within one year from the
date of postponement. Except as specified above, no credits will be issued for cancellations. There
Name On Card: Signature: are no refunds given under any circumstances. IQPC is not responsible for any loss or damage as
a result of a substitution, alteration or cancellation/postponement of an event. IQPC shall assume
no liability whatsoever in the event this conference is cancelled, rescheduled or postponed due to a
Billing Address (if different from below): fortuitous event, Act of God, unforeseen occurrence or any other event that renders performance of
this conference impracticable, illegal or impossible. For purposes of this clause, a fortuitous event
shall include, but not be limited to: war, fire, labour strike, extreme weather or other emergency.
City/County/Postcode Cheque enclosed for: € (Made payable to IQPC Ltd.) Please note that while speakers and topics were confirmed at the time of publishing, circumstances
beyond the control of the organizers may necessitate substitutions, alterations or cancellations of the
speakers and/or topics. As such, IQPC reserves the right to alter or modify the advertised speakers
(Please quote 19170.002 with remittance advice) and/or topics if necessary without any liability to you whatsoever. Any substitutions or alterations
IQPC Bank details: HSBC Bank Plc, 67 George Street, Richmond, Surrey, TW9 1HG, United Kingdom will be updated on our web page as soon as possible. Discounts: All ‘Early Bird’ Discounts
require payment at time of registration and before the cut-off date in order to receive any discount.
Sort Code: 40 05 15 Account No: 59090618 IBAN Code: GB98 MIDL 4005 1559 0906 18 Any discounts offered by IQPC (including team discounts) also require payment at the time of
Swift Code: MIDLGB22 Account name: International Quality & Productivity Centre Ltd registration. Discount offers cannot be combined with any other offer.
PAYMENT MUST BE RECEIVED PRIOR TO THE CONFERENCE