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www.a3p.orgA3P Services22, Rue Aristide Briand - 45220 Château-Renard - France
Tél. +33 (0)2 38 071 071 - Fax +33 (0)2 38 071 072E-mail : [email protected]
CONGRESS
June 3rd & 4th, 2014Espace Tête d’Or, LYON - France
SIMULTANEOUS TRANSLATION FRENCH/ENGLISH
Lectures - Workshops - Exhibition
Visit of BioProduction Sites, Genzyme & Sanofi Pasteur
Upstream, Downstream & Formulation
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Introduction
RationaL to LaUnch it & REasons to attEnD itWhy should i attend the a3P Bioproduction while there is already a large & well established Biotechnology events offering?Behind that basic, but challenging question raised by some of you during the preparation phase, we should understand all the concerns related to our increasing individual workload, our overbooked agenda, our company travel cost restrictions and ultimately, the value added to attend such a new event.
so, WhY LaUnchinG a nEW BiotEchnoLoGY EVEnt?Over the last 2 decades, biotechnologies exploded in many industry sectors calling for the definition of 5 sub-categories (white, red, green, yellow, blue biotechnologies). Considering only red biotechnology focusing on health & medical sectors, the diversity & complexity of the technics have led to the creation of a variety of specific events where eminent academic, public & private scientists & experts share their knowledge on topics such as medical biotechnology, stem cells, gene therapy, tissue engineering, bio-pharmaceutical manufacturing, cell based therapy, cell cultivation, diagnostics, imaging, pharmacogenomics, microarray technology, biomarkers, pharmaceutical biotechnology, vaccines, Cancer, antibodies, protein engineering, clinical reserved/clinical trials, bioethics and Nano biotechnology.Despite the increasing space that has been given to some biotechnology topics in your recent A3P events, the industry leaders considered it was not enough to justify any active participation or any investment into them. But in order to fill a gap, they strongly encouraged us to create a similar event, obviously international, focusing on all the bioproduction aspects and keeping the philosophy which drove the A3P success in aseptic processing over the last 26 years, I mean: innovation, Pragmatism & networking.
toP 5 REasons to attEnD it?
1. The congress will cover the hottest bioproduction topics applied to vaccines, rec. proteins, biosimilars & blood derived products from the development phases up to manufacturing scale. The targeted audience includes mid and senior level professionals from the biopharmaceutical industry, suppliers and regulators, process development scientists, technology transfer managers, manufacturing managers, engineers, quality assurance professionals, quality control professionals, risk assessment professionals.
2. The event will be truly international with speakers coming from global & local biotechnology companies. The A3P organizing committee is pan-European and has already planned to rotate the congress location between Belgium, Switzerland & France every 3 years. The official congress language will be English.
3. The agenda has been drafted to present case studies & testimonies from users with a solid industrial experience and who can provide a valuable feedback about the gains and the pains they encountered during some recent projects execution. Topics will address current challenges to optimize and implement an Upstream (USP), Downstream (DSP) & formulation platform with a strong emphasize on risk assessment concept, quality by design (QbD) perspective & process monitoring.
4. The 2 days program has been designed to provide a good balance between plenary lectures delivered by key opinion leaders, interactive workshops co-animated by a tandem of biotech users & trusted suppliers, direct interactions at the supplier’s booths and the choice between 2 plant visits.
5. The multidisciplinary nature of the congress as well as the unique interactive atmosphere of all the A3P events, are creating thE real differentiating factors among other existing forum. Indeed, each congress section has been though to generate fruitful exchanges between speakers, animators, users, suppliers, experts, facilitators through panel’s discussions, interactive workshops, coffee breaks & lunch cocktails at the supplier booths.
Ultimately, the 1st A3P International Bioproduction Congress will offer the opportunity to develop your industry network with leaders sharing the same concerns as yours & to gain visibility for you and your company within that small industry galaxy.
… Did i answer your initial question?
Alain RACHON - Merck Millipore
Press Partners
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Program - June 3rd & 4th, 2014
tUEsDaY, JUnE 3, 20148h Welcome of the participants
8h30 introduction Lecture Benoit DUBUIS - Eclosion (Switzerland)
9h intergrated Design to cost approach in a newly built UsP Platform Marc VOUILLAMOZ - LFB Biomanufacturing (France)
9h25 the impact of the Up-stream Design on the Product Quality Jens POHL- Glycotope Biotechnology (Germany)
9h50 Quality by Design at Merck serono: Lessons learned from the FDa pilot program Pascal VALAX- Merck Biodevelopment (France)
10h15 Questions & answers
10h30 Break and Exhibition Visit
11h30 technical steps linked to the production of Biopharmaceutical Franck PAVAN - Pierre Fabre Médicament Production (France)
11h55 Process Excellence in Biopharmaceutical Production - From troubleshooting to continuous improvement Christoph HOH - Sanofi (Germany)
12h20 how to increase your protein concentration with single-pass tFF (tangential Flow Filtration) Christophe CARNEWAL - Baxter (Belgium)
12h45 Questions & answers
13h Lunch on the Exhibition
15h VisitofBioproductionsites(Genzyme&SanofiPasteur)
19h End of the visits and back to the congress center (Espace tête d’or)
20h Diner
WEDnEsDaY, JUnE 4, 20148h Welcome of the participants
8h30 Development of formulation for Biologics (BFD) group Claude PEERBOOM - UCB (Belgium)
8h55 innovative approaches to formulation of therapeutic proteins and vaccines Jan JEZEK - ARECOR (UK)
9h20 characterisation of therapeutic proteins : the importance of the glycosylation Luc-Alain SAVOY - SGS M-Scan (Switzerland)
9h45 Questions & answers
10h Break and Exhibition Visit
11h Workshops part i - theoretical
13h Lunch
15h Workshops part ii - Exercises & case studies
16h30 Break and Exhibition Visit
17h Workshops part iii - Restitution & conclusion
18h30 End of a3P Bioproduction congress 2014
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June 3rd & 4th, 2014
INTERACTIVE WORKSHOPS WEDnEsDaY, JUnE 4, 2014
Workshop -1- Managing a successful biodevelopment project through an external collaboration. Perspectives from the client & the services providerSébastien RIBAULT – Merck BioDevelopement & Christian BELMANT – Innate PharmaAs the large biopharmaceutical industries are facing an increasing financial and regulatory pressure, strategic utilization of third party service provider is increasing at unprecedented rate. The workshop will cover the different aspects that need to be considered, discussed and agreed between the client and the contract development organization (CDO’s) in the context of a biological drug process development and/or a clinical batch supply project. Selection criteria, legal concerns & IP protection, project management and CMC documentation, regulatory as well as technical transfer supports will be among the main topics reviewed from both parties side.Targeted audience: Biotech start-up decision makers, Head of Development and External Collaborations Directors from Biotech industry, Process Developers, Technical transfer Directors, QA/QC Managers, Regulatory experts.
Workshop -2- The biosafety of a medicine from the phase I to the MAA (market authorisation application)Bruno YOU – LFB & Wahiba OUALIKENE-GONIN - ANSMDuring the development of a medicine from biotechnological origin or derived from plasma, the efficiency of the downstream process for eliminating or inactivating potential viral contaminants is a crucial part of the submission dossier.After a brief reminder of the guideline requirements and from case studies covering the whole cycle of develop-ment product, the biosafety of products will be discussed. This workshop concerns firstly people involved in the development and/or the validation of processes purification.
Workshop -3- A scalable Approach for Cell Culture Media Selection: Successfull Optimisation for your Process Development towards GMP Manu-facturingHenri GILBERT – Sartorius Stedim & Gilles KERHUEL – Glenmark PharmaceuticalsMedia optimization is fully part of biopharmaceutical process development. The complexity of media composition provides opportunities to challenge ingredients to boost productivity and yield. Still this can require intensive work load and intensive understanding of cell culture parameters. This workshop will be a great opportunity to exchange on consideration to be taken into account when developing media, including upstream processes impact, scalability and quality requirements. We will also try to better understand the authorities expectations in a highly regulated environment.
Workshop -4- TFF (Tangential Flow Filtration): meet the new challenges of biotechnologiesChakib BORSALI – Novartis Pharma & Yves MIALON – Pall FranceCurrent trends in biotechnology manufacturing include not just high purity products, but high concentration products with large starting volumes and the need for auto-mated processes and online control. During this workshop, after a review of classic TFF technology with recirculation we will introduce the new TFF single pass technique. Aspects of online control of protein concentration will be discussed as well as process automation.
Workshop -5- Definition of the deliverables from step 1 before starting step 2 of the new FDA guidance on process validation Sanofi PasteurIn January 2011, FDA revised the guideline on general principles of process validation dated on May 1987.The new guidance for Industry, called, Process validation: general principles and practices is based on activities taking place over the lifecycle of the product and process and includes 3 stages: Stage 1: Process Design, Stage 2: Process Qualification, Stage 3: Continued Process Verification.The workshop will be focused on stage 1: Process Design corresponding to the definition of the manufacturing process based on knowledge gained through development and scale up activities in order to design a process suitable for routine commercial manufacturing that can consistently deliver a product that meets in quality attributes.But behind this theory, it is often difficult to know exactly what level of knowledge is necessary, which the studies to be performed are and which the associated deliverables are before starting the stage 2. This workshop will thus be the place to answer all these questions in a practical way.
EXhiBitionit’s not too late if you wish to exhibit!contact a3P services [email protected]
Exhibition file and registration form on www.a3p.org
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June 3rd & 4th, 2014
VISIT OF BIOPRODUCTION SITES tUEsDaY, JUnE 3, 2014
GEnZYME LYon PoLYcLonaLs FRancEA state-of-the-art facility and a team of experts dedicated to delivering products to patients worldwide.Genzyme Lyon is focused on delivering thymoglobulin to 65 countries. The Gerland site is located in the heart of the Lyon Biotech Hub - “LyonBioPole”. Thymoglobulin is a freeze-dried powder of anti-human Lymphocyte T antibodies (Rabbit) and is used for organ and bone marrow transplantation as well as aplastic anemia. The thymoglobulin manufacturing process involves three different sources of bio-materials: immune rabbit sera from specific pathogen-free rabbit breeding farms, human red blood cells from the American Red Cross, and human T lymphocytes donated from 45 hospitals worldwide. The immune rabbit serum is purified in the Lyon facility during a 4-day purification process which mostly includes chromatography, ultra-filtration, precipitations and viral inactivation steps. Thymoglobulin is lyophilized at the Waterford Ireland facility. The Genzyme Lyon team is responsible for the management of all bio-materials, purification steps and release up to lyophilized vials. The site features compelling architecture and “green” design, and is certified to French and US high environmental quality standards. Lyon Genzyme is part of the Biotechnology operational unit.
Identity CardEMPLOYEES: Approx. 250PRODUCTS: Thymoglobulin®
REGULATORY STATUS: FDA, ANSM, MHRA, EMEA, PMDA approvals and 60 other authorities
Key Figures99% success rate in 201297% CAPAs* closed on time for 4 consecutive years*CAPAs: corrective action and preventive action
sanoFi PastEUR MaRcY L’EtoiLEA strategic site for Sanofi Pasteur’s industrial operations.A center of expertise for the manufacture of vaccines to be distributed worldwide, the Marcy l’Étoile site has the largest inactivated polio vaccine (IPV)production capacity in the world. Our site is also the global producer of Haemophilus Influenzae type b (Hib) infection vaccines.All the skills necessary for every stage of vaccine production, in compliance with regulatory requirements: from the active ingredient to the packaging, including quality control operations.
Globally recognized know-how in the processes, technologies and equipment used: - Site at the origin of industrial production of bacterial vaccines and a
pioneer in the creation of viral vaccines, - Mastery of all the complex techniques for bacterial and viral vaccine
production, - Continuous freeze-drying and thermostability technologies, - 1,000-liter single-use biofermentors, - Modeling and mastery of process behaviors, - Industrial scale-up of complex pediatric formulations.
A site that meets international regulatory requirements: - 70% of production time is devoted to quality control, - Vaccines comply with the world’s highest regulatory standards
(approvals from the ANSM, FDA, Japan, etc).
accEss PLanEspace tête d’orRoaDPeripheral North Take exit number 4 “Porte de Saint-Clair’’, direction Part-Dieu and Villeurbanne and carryon for 1.1 KM
tRain10 Minutes from rail station Part-Dieu Lyon - Paris : 2 h Lyon - Genève : 1 h 45 Lyon - Marseille : 1 h 35
PLanE20 Minutes from International air-port Lyon Saint Exupéry
PUBLic tRansPoRtationBus: Lines C2, C26 & 70, Connection express with the Station Part Dieu, Stop “Parc Tête d’Or Stalingrad” (100m) Tramway: Line T1, Stop “Le Tonkin” (5 min) Subway: Lines A & B, Stop “Charpennes” (10 min)
VELoV (Public cycle Rent)Station Stalingrad / Méliès Station Bd du 11 Novembre 1918 Station Bd Stalingrad / Rue Charlie Chaplin
FREE PRiVatE PaRKinG 33, rue Louis Guérin, Capacity of 180 places on 3 levels
ROAD
Peripheral North Take exit number 4 ‘’Porte de Saint-Clair’’, direction Part-Dieu and Vil-leurbanne and carryon for 1.1 KM
TRAIN
10 Minutes from rail station Part Dieu Lyon - Paris : 2 h Lyon - Genève : 1 h 45 Lyon - Marseille : 1 h 35
PLANE
20 Minutes from International air-port Lyon Saint Exupéry
PUBLIC TRANSPORTATION
Bus : Lignes C2, C26 & 70, Connection express with the Station Part Dieu, Stop « Parc Tête d’Or Stalingrad » (100m) Tramway : Ligne T1, Stop « Le Tonkin » ( 5 min) Subway : Lignes A & B, Stop « Charpennes » ( 10 min)
VELOV
Station Stalingrad / Méliès Station Bd du 11 Novembre 1918 Station Bd Stalingrad / Rue Charlie Chaplin
FREE PRIVATE PARKING
33, rue Louis Guérin, Capacity of 180 places on 3 levels
ACCESS
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June 3rd & 4th, 2014
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Code Postal/Zip code ...............................................Ville/City ....................................................................................
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Tél./Phone # ................................................... Port./Mobile # ....................................................................................
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m Je suis déjà adhérent A3P1 et m’inscris au Congrès A3P Bioproduction 2014 .................850,00 € HT/without VAT I am an A3P member1 and I register to the A3P Bioproduction Congress 2014 1 Adhésion individuelle en cours de validité à la date de l’événement/Individual membership valid at the date of the event.
m Je deviens adhérent A3P2 et m’inscris au Congrès A3P Bioproduction 2014 ...............1 030,00 € HT/without VAT I become an A3P member2 and I register to the A3P Bioproduction Congress 2014 2 Adhésion individuelle incluse de 180,00 € HT/Included indvidual membership of 180,00 € without VAT.
m Je m’inscris à l’atelier n° / Workshop registration # ................
Ne cocher qu’une seule case / Please tick one box
m Je souhaite participer à la visite du site de Genzyme (dans la limite des places disponibles : maximum 100 participants) I will attend visiting the site Genzyme (limited for availability: up to 100 participants)
m Je souhaite participer à la visite du site de Sanofi Pasteur, Marcy l’Etoile (dans la limite des places disponibles : maximum 40 participants) I will attend visiting the site Sanofi Pasteur, Marcy l’Etoile (limited for availability: up to 40 participants)
m Je ne souhaite pas participer à une visite de site I do not wish to participate in a site visit
Règlement à l’ordre d’a3P services/Payment to a3P services totaL ..............................................m Virement bancaire/Bank transfert : Banque Populaire : N° 18707/00220/07221113330/84 - Code Swift : CCBPFRPPVER
IBAN : FR76 1870 7002 2007 2211 1333 084
m Chèque bancaire/Only for french companies
m Carte bancaire n° /_/_/_/_/ /_/_/_/_/ /_/_/_/_/ /_/_/_/_/ Date d’expiration /_/_/ /_/_/ Crypto. /_/_/_/_/ Credit card n° Expire date Crypto. Visa / AMEX / Master Card / Eurocard Les 3 ou 4 derniers chiffres au dos de votre carte The lest 3 or 4 digists at the back of your credit card
L’inscription ci-dessus a pour effet d’accepter les conditions de cette inscription et notamment d’autoriser A3P à publier les différents supports (photos, video) enregistrés par A3P au cours des manifestations programmées (congrès, ate-liers, formation).
The registration above has the effect of accepting the conditions of registration and in particular to allow A3P to publish various media (photos, video) recorded by A3P du-ring events (meetings, workshops, training).
Date .....................................
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Les informations recueillies font l’objet d’un traitement in-formatique destiné à la base de contacts A3P et sont sus-ceptibles d’être communiquées à des tiers par le biais des différents supports de communication A3P. Conformément à la loi “informatique et libertés” du 6 janvier 1978 modifiée en 2004, vous bénéficiez d’un droit d’accès et de rectifica-tion aux informations qui vous concernent, que vous pouvez exercer en vous adressant à A3P Services - Tél. +33 (0)2 38 071 071 - Mail : [email protected]. Vous pouvez égale-ment, pour des motifs légitimes, vous opposer au traitement des données vous concernant. Only for french people.
À retourner avec votre règlement TTC au taux en vigueur / To be returned with your payment to A3P Services - Inscriptions A3P Bioproduction Congress 2014 - 22, rue Aristide Briand - 45220 Château-Renard - France
e-mail : [email protected] - Tél. +33 (0)2.38.071.071 - Fax. +33 (0)2.38.071.072TVA 20% - En cas d’annulation, formulée par écrit (fax ou courrier), 50% du montant de l’inscription seront retenus. La totalité un mois avant le début de l’événement.
In case of cancellation received by fax or by mail, 50% of the registration will be retained and the full amount one month before the event.
