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Adventitious Agent Pdfw

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Ensuring …

Ensuring
Adventitious
Agent Sa fety
in Biologics Agenda

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  • 1. Ensuring Register Pay by 1s & t July AdvEntitious and save up to €450 AgEnt sAfEty in Biologics 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 E: enquire@iqpc.co.uk t: +44 (0)20 7368 9300 f: +44 (0)20 7368 9301
  • 2. Advisory BoArdthanks to our advisory board for lending their expert advice; their feedback and suggestions have been instrumentalin helping to shape our programme!Mark Plavsic, senior director of corporate dayue Chen, Research advisor, Eli lillyBiosafety, genzyme Hans rogl, manager development Recovery &thomas r. Kreil, Ph.d., associate Professor of downstream Processing, roche diagnosticsvirology, senior director, viral vaccines & globalPathogen safety, Baxter Bioscience Barbara Potts, senior consultant, Potts and nelson Consulting, llC, chair, mycoplasma taskJames robertson, Principal scientist, virology, Force, PdAniBsCyour ExPErt sPEAKEr fACultyHans noordergraaf, microbiological specialist, Qc fazal Khan, senior vice President of manufacturing,microbiology, Abbott Biologicals B.v. Merrimack PharmaceuticalsMarc Martin, viral safety assessor, AfssAPs Emiliano toso, molecular Biology lab Head, Merck seronothomas r. Kreil, Ph.d., associate Professor ofvirology, senior director viral vaccines & global rebecca sheets, vaccine scientific and RegulatoryPathogen safety, Baxter Bioscience specialist, niH/niAid (pending official approval)Albrecht gröner, Head of Pathogen safety, Csl Jens-Peter gregersen, sme virology, virusBehring safety, new Projects R&d, novartis vaccines and diagnosticsMarie Murphy, microbiologist, Eli lilly Jürgen Hubert Blusch, Head cell line andsantosh nanda, microbiologist/Primary Reviewer, adventitious agents analytics, novartis AgcBeR, fdA (pending offical approval) Kristin Murray, senior manager gcmc Regulatory,nathan Jones, senior scientist, genzyme PfizerWalter de Matteo, microbiological laboratory steven reich, Risk management Principal, globalmanager, Quality control, iBsA institut Quality, PfizerBiochimique sA Barbara Potts, senior consultant, Potts androsa Anna siciliano, Proteomic and Biomolecular nelson Consulting, llc, chair, mycoplasma taskmass spectrometry center, institute of Food science, Force, PdAitalian national research Council (Cnr) Holger Kavermann, manager Qc, rochetanja opriessnig, associate Professor, departmentof veterinary diagnostic and Production animal sebastien Carayol, manager of scientificmedicine, veterinary diagnostic laboratory - iowa Bioprocess R&d, downstream Process, sanofistate university PasteurJürgen A. richt, director, dHs center of excellence Hans nitschko, doctor of diagnostic virology, maxfor emerging and Zoonotic animal diseases (ceeZad), von Pettenkofer institute, university of MunichKansas state universityw w w. adventitiousagentse vent.comE: enquire@iqpc.co.uk t: +44 (0)20 7368 9300 f: +44 (0)20 7368 9301 2
  • 3. PrE-ConfErEnCE foCus dAy 17 OCTOBER 2011 MyCOplasMa MiTigaTiOn08.30 Coffee and Registration09.00 Chair’s Opening Remarks and Pharma IQ Welcome09.10 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 A10.20 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, PdA12.20 Networking Lunch Break WorKsHoP B13.30 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 serono15.30 Networking Coffee Break16.00 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, roche16.40 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 serono17.20 Chair’s Closing Remarks and End of Focus Dayw w w. adventitiousagentse vent.comE: enquire@iqpc.co.uk t: +44 (0)20 7368 9300 f: +44 (0)20 7368 9301 3
  • 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 E: enquire@iqpc.co.uk t: +44 (0)20 7368 9300 f: +44 (0)20 7368 9301 4
  • 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 youclean up your • Surveying available methods for post-contamination cleanupcontamination 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 E: enquire@iqpc.co.uk t: +44 (0)20 7368 9300 f: +44 (0)20 7368 9301 5
  • 6. sPonsorsHiP & ExHiBition www.adventitiousagentsevent.comMaximise your involvement: sponsorship and Exhibition opportunitiesThe 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 companys 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 requirementsFor more information and to discuss the right opportunity, contact Yaw Asamani on+44 (0)207 368 9300 or yaw.asamani@iqpc.co.uk partner associations: Media partners: Who you Will Meet: About Pharma iQ • Directors of QA/QC • Heads of Biosafety and Viral Safety • Virologists • Heads of Process Development Web: www.pharma-iq.com • Scientific Managers Become a member of Pharma IQ and receive • Microbiologists complimentary access to resources that will keep • Heads of Regulatory Affairs you at the forefront of industry change. you will • Directors of Manufacturing receive access to our growing library of multimedia • Senior Scientists presentations from industry leaders, an email • Risk Management Analysts newsletter updating you on new content that has been added, free aggregated news feed from over From biotech, pharmaceutical, biopharma 1000 global news sources tracking your industry and and regulatory organisations special member only discounts on events. Become a member here: www.pharma-iq.com share your knowledge follow us on on our facebook page, Join us on linkedin ADVENTITIOUS AGENT SAFETY twitter @Adventsafe IN BIOLOGICS Adventitious Agents safety Attendees by Job function Attendees by Country scientist germany Laboratory Specialist United Kingdon Organisation & France Development Manager Switzerland Development Chemist italy Regulatory Affairs Director The netherlands Executive/Senior Manager Denmark Team leader/Coach austria Director Business Development Director/Manager Specialist/Expert Advertising/Account Executive/ Director/Manager Marketing Director/Manager Quality Head/Director ManagerE: enquire@iqpc.co.uk t: +44 (0)20 7368 9300 f: +44 (0)20 7368 9301 6
  • 7. Ensuring AdvEntitious two-day Conference: 18-19 october 2011 5 Ways to Register Pre-Conference focus day: AgEnt sAfEty 17 october 2011 0800 652 2363 or in Biologics nH München dornach, FREEPHONE: Munich, germany +44 (0)20 7368 9300 to speed registration, please provide the priority code located on the mailing label or in the box below. FAx: +44 (0)20 7368 9301 my registration code PDFW Please contact our database manager on +44(0) 207 368 9300 or database@iqpc.co.uk quoting the pOsT: your booking form to registration code above to inform us of any changes or to remove your details. IQPC, 129 Wilton Road, Victoria, London, only €899 for pharma and biotech! SW1 V1JZ Register Register Register and PHARMA AND Standard and pay by and pay by pay by 16th enquire@iqpc.co.uk ✔ BIOTECH PRICING* Price EMail: 1st July** 29th July** September** ¤699+VAT ¤749+VAT ¤799+VAT Conference only ¤899+VAT SAVE ¤200 SAVE ¤150 SAVE ¤100 ¤1948+VAT ¤1998+VAT ¤2098+VAT www.adventitiousagentsevent.com Conference + Focus Day*** ¤2348+VAT SAVE ¤400 SAVE ¤350 SAVE ¤250 Conference + Workshop*** ¤1748+VAT ¤1798+VAT ¤1898+VAT ¤2098+VAT (choose Workshop A or B) SAVE ¤350 SAVE ¤300 SAVE ¤200 Conference only + Full Access ¤1199+VAT ¤1249+VAT ¤1349+VAT ADVENTITIOUS to Conference Recordings SAVE ¤250 SAVE ¤200 SAVE ¤100 ¤1449+VAT AGENT SAFETY IN BIOLOGICS Join our LinkedIn group! Register Register Register and Standard SERVICE PROVIDERS* ✔ and pay by and pay by pay by 16th Price 1st July** ¤2948+VAT 29th July** ¤2998+VAT September** ¤3098+VAT TEAM DISCOUNTS* Conference + Focus Day*** ¤3348+VAT SAVE ¤400 SAVE ¤350 SAVE ¤250 IQPC recognises the value of learning in teams. Groups of 3 or more booking at the Conference + Workshop*** ¤2748+VAT ¤2798+VAT ¤2898+VAT ¤3098+VAT same time from the same company receive a 10% discount, 5 or more receive a (choose Workshop A or B) SAVE ¤350 SAVE ¤300 SAVE ¤200 15% discount, 7 receive a 20% discount. Only one discount available per person. Conference only + Full Access ¤2199+VAT ¤2249+VAT ¤2349+VAT ¤2449+VAT to Conference Recordings SAVE ¤250 ¤1699+VAT SAVE ¤200 ¤1749+VAT SAVE ¤100 ¤1799+VAT VENUE & ACCOMMODATION Conference only ¤1899+VAT SAVE ¤200 SAVE ¤150 SAVE ¤100 VENUE: NH München Dornach, Einsteinring 20, D-85609, München, Germany, * Please note pharma and biotech pricing does not apply to service providers, including CMOs, CTOs, etc. ** To qualify for discounts, payment must be received with booking by the discount deadline. Tel: +49.89.9400960, Email: nhmuenchendornach@nh-hotels.com Early booking discounts are not valid in conjunction with any other offer. 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