A3P BIOPRODUCTION INTERNATIONAL CONGRESS
GMP Biomanufacturing – Scale up, Scale down, Scale out –
Purification & Chromatography

Lieu

Starling Hôtel de Genève

DATE

27 et 28 juin 2018

Format

Conférences, ateliers, exposition

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. The 3 topics we have selected for 2018 are:

  • GMP Biomanufacturing
  • Scale up, Scale down and Scale out
  • Purification & Chromatography

Our audience is coming from Process Dev, Manufacturing, Engineering & QA/Regulatory people. 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 and direct interactions at the supplier’s booths. 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.

Wednesday, June 27th

Welcome
09:00
Biotech processes : shaping the future ?
Alain BERNARD - AB CONSULTING
09:30
mAb purification process intensification: evaluation of a fully-connected DSP process operated in flow-through mode
Nicolas LAROUDIE – MERCK
10:00
Coffee Break & Exhibition Time
10:30
Addressing the need for increased productivity in mAb downstream bioprocessing
Annika FORSS – GE Healthcare Life Sciences
11:30
Challenges and Advances in Cleaning Ultrafiltration membranes
Beth KROEGER – STERIS
12:00
Lunch in the exhibition
12:30
WORKSHOPS
6 simultaneous workshops sessions throughout the afternoon, animated by ABCONSULTING, BOEHRINGER INGELHEIM, GSK VACCINES, LFB, MERCK, R-PHARM, SARTORIUS, SGS, SOURCIN, STERIS, THERMOFISHER
Registration to the workshop of your choice mandatory, find the summaries on the workshop tab
14:00
Cocktail in the exhibition
19:00

Thursday, June 28th

Welcome
08:30
New approaches for Upstream scale-up transfer
Flavien THUET - MERCK
09:00
Scale down model: strategy for implementation - learning and feed back from a case study on adherent cells culture and viral culture with Poliovirus
Aurélie DUFOSSE & Romaric LEFEVRE – SANOFI PASTEUR
09:30
Challenges and strategies in Technology Transfer of mAbs - case study at 10K scale
François RAGOT – SANOFI
10:00
Coffee Break & Exhibition Time
10:30
Comparability: the lifeline for your product development and beyond
Jean-Pierre FONTA - AUCTRIS
11:30
Addressing the scale-up of viral vectors production by transient transfection in adherence and suspension mode: optimized PEIpro-mediated transfection
Linda YAHIAOUI & Myriam GABET - NOVASEP
12:00
Lunch in the exhibition
12:30
Relevance of ASTM and ISTA Standard Shipping Simulation studies for the validation of real-world shipping of Drug Substances and scientific basis to set the right testing cycles
Elisabeth VACHETTE – SARTORIUS & Victor HUART - METROPACK
14:00
Challenges in industrial scale chromatography
Volker WEIMAR – OCTAPHARMA
14:30
Reducing Variability in Human Performance by Integration of Lean to Increase Productivity and Quality in Biopharma Downstream Manufacturing
Michael MOEDLER – LONZA
15:00
Coffee Break & Exhibition Time
15:30
Productivity improvement for the manufacturing process of biological drug
Gilles BOURDIN – UCB
16:00
From the process to installation how to make a workshop flexible and agile
Thierry JAKYMIW - GENZYME & Marc BERTRAND – TECHNIPFMC
16:30
End of the Congress
17:00

A3P workshops gather during half a day a limited number of people around a defined subject with two specialists and an A3P moderator. Purpose: To allow the participants to this congress to work together for an initial or a deeper knowledge either upon a defined technical or a regulatory matter from a theoritical or a practical point of view.

The defined subject is mainly explained and explored through shared case studies.The results/solutions of these case studies lead to written conclusions. The two facilitators are specialists from theory and practice upon the subject of the workshop. Their pedagogic approach of the subject must avoid any commercial and/or marketing matter.

Workshops sessions - 27th June
14h00
Using the BPSA best practices guide “design, control, and monitoring of single-use systems (SUS) for integrity assurance” to build a robust Container Closure Integrity (CCI) Strategy from supplier to end-user
Animators : Charlotte MASY - GSK VACCINES & Carole LANGLOIS - SARTORIUS
Moderator : Alain RACHON - MERCK
This workshop will discuss how BPSA recommendations can be implemented in real conditions (illustrated by case studies) to build an appropriate and comprehensive CCI strategy all along the Single-Use System life cycle. It will show that integrity assurance is a shared responsibility between supplier and end-user, which should be built on Quality by Design (QbD), Quality Risk Management (QRM), process validation and in-process controls. This approach, based on the understanding of the leak size and microbial ingress mechanisms, is supported by supplier integrity testing and end-user point-of-use leak testing. Attendees will have the opportunity to practice a risk analysis to identify the potential issues for SUS integrity and to set their own CCI strategy based on risk management. They will also learn about two main testing methods: pressure decay leak test and Helium integrity test. Open discussion around further developments (regulatory positioning, bacterial challenge studies, post-use testing) will also be organized.
Workshop 1
Single Use Systems and supplier selection: how to define your user requirements, control your process from end to end, and secure your supply-chain ?
Animators: Eric DREVETON - BOEHRINGER INGELHEIM & Camille DESROUSSEAUX - THERMOFISHER
Moderator: Arnaud SCHMUTZ - SOURCIN
Single-use systems (SUS: single - use systems) are developing significantly in order to meet the needs of industry: ease and speed of implementation, indirect response to the cleaning validation issues, flexibility, CAPEX reduced... The use of such technologies leads to outsourcing and delegation to the provider of an important part of the process control that can impact, between other, product quality, supply chain and cost. It is therefore important to set up a strong partnership with the selected suppliers. In this workshop, we propose to review the selection criteria for your future provider of SUS (writing of the User Requirements Specifications and the specifications). Once this exercise will be conducted, it is important to implement actions to secure the supply chain and control process in which in SUS are used. During various exchanges and exercises, we will define a common approach to answer to these questions. We will also briefly present the results of the Common Group of Interest on Single Use.
Workshop 2
Particulates in Biologics Under the Spotlights!
Animators: Laurent SIRET - LFB & Jean-François BOE - SGS
Moderator: Roland BELIARD - LFB
Protein drugs, which are the fastest growing sector of the biopharmaceutical industry, could contain traces of protein aggregates or exogenous particles which are clearly identified as one of the potential immunity-provoking factors. Ensuring the safety and efficacy of Biopharmaceuticals requires a good understanding of any correlation between the amount and characteristics of aggregates and adverse immune response in patients. To this aim Regulatory agencies are demanding more and more information (size, morphology, …) on the nature of particles within a pharmaceutical product. New guidance has recently been issued which provides a harmonized approach between US and EU requirements but some confusing interpretation remains. During this WorkShop we will discuss the best practices in terms of analytical tools, quality control, particle characterization and setting acceptance criteria to comply with Agency’s requirements and expectations.
Workshop 3
Cleaning validation including Concentration/Ultra Filtration membrane: a Quality by Design approach
Animators: Stéphane COUSIN - GSK & Walid EL AZAB - STERIS
Moderator: Patrick MAHIEUX - ABLEUROPE
The workshop focuses on the cleaning validation and monitoring of the UF/DF membranes. During the workshop, we will discuss a risk-based method to define the Critical Quality Attributes (CQA) and Critical Cleaning Process (CCP) for the UF/DF cleaning validation and monitoring. Also, during the workshop the attendees will have the opportunity through an exercise to develop a risk-based assessment to determine the CPP and monitoring program to put in place to ensure robust and reproductible cleaning and lifetime of the UF/DF membranes. In addition, the objective is also to share the supplier side and an end-user side regarding UF/DF cleaning validation and strategy and program (cleaner choice, qualification of the UF/DF, extractible and leachable, cleaning validation, hold time, lifetime....) including the routine and on-going monitoring. Finally, you could advise/share on the lessons learned or failure that might happen during validation and routine use.
Workshop 4
Quality by Design: the good, the bad and the ugly
Animators: Alain BERNARD - ABCONSULTING & Amer JABER - R-PHARM
Moderator: Vincent GRIFFOUL - R-PHARM
QbD has been "launched" mainly by FDA several years ago. There are still a lot of misconceptions, fears, rejections or adoptions in different parts of the pharma industry. This workshop will aim at "demystifying" the concepts, explain how QbD works and can be implemented in a smooth way in order to use a more scientific, risk-based, holistic and proactive approach to pharmaceutical development. We will illustrate how a QbD based technical development promotes understanding of the product and manufacturing process and ensure that quality is built in, as opposed to being tested at the end. Ultimately we will demonstrate that an appropriate QbD approach, intimately integrated into e process development project, can create very significant value.
Workshop 5
Reducing production operator errors and deviations through an effective training program strategy
Animators: Pascal PORTMANN & Lucie MARCOS - MERCK & Flora CHARBONNIER & Maëlle PASQUIOU - SOURCIN
Moderator: Anne RIGOULOT - SANOFI
Training is mandatory in the biopharma industry. However, the increasing level of complexity of the technologies used creates a very demanding environment for the operators. Operation managers are re-thinking their training strategy. The objective is to move from the “read & sign” model to implement operator training programs promoting effective acquisition of competences. Through experience sharing, the workshop will review the factors contributing to errors and deviations in production. Ways of improving training effectiveness and knowledge retention will be explored. This session will also be the occasion for attendees to get insights of educational methods enhancing training experience and facilitating knowledge retention.
Workshop 6
End of the workshops / Cocktail in the exhibition
19:00

Plan de l’exposition

SociétéN° StandSociétéN° Stand
 SARTORIUS1 ASSOCIATES OF CAPE COD20
 JAG JAKOB PROZESSTECHNIK2 DAICEL / CHIRAL21
 BIION3 AZBIL TELSTAR22
 SYSTEM-C BIOPROCESS4 NNE23
 OPTIMA PHARMA5 SYMBIOSE ENVIRONNEMENT24
 ILC DOVER6 BORER CHEMIE25
 PALL BIOTECH7 CMI26
 VWR INTERNATIONAL8 TECHNIP FMC27
 MEISSNER9 ASSYSTEM EOS28
 THERMOFISHER10 BWT AQUA AG29
 COOLVACUUM TECHNOLOGIES11 CORNING INCORPORATED LIFE SCIENCES30
 EZI-DOCK SYSTEMS12 CELLON31
 BIOQUELL13 OUAT!32
 CONFARMA14 INDATECH33
 ERMAFLUX15 PHARMADEC34
 ASEPTIC TECHNOLOGIES16 BACCINEX35
 PUROLITE17 POLYPLUS TRANSFECTION36
 SGS FRANCE LIFE SCIENCES18 MERCK37
 STERIS19

Prestations comprises avec le stand

  • Un espace d’exposition dédié avec système de stand rétro-éclairé : votre communication visuelle sera imprimée sur toile et projetée.
  • Une dotation de base comprenant une table, 2 chaises et 1 raccordement électrique, une table à café et une cafetière Nespresso avec des dosettes
  • Les pauses et les repas indiqués dans le programme
  • Wifi illimité
  • Un badge qui vous permet le libre accès à l’ensemble du programme technique et scientifique
  • La liste des participants à l’évènement
  • Possibilité d’inscrire une personne supplémentaire au tarif spécial « accompagnant » (590€ HT)
[Form inscriptionbioprod not found!]

Contact

En fonction de vos impératifs et de vos préférences, vous pouvez contacter Nina CHATRE :

Téléphone : +33 (0)4 37 28 30 47
Fax : +33 (0)4 37 28 30 60
Email : nchatre@a3pservices.com
Courrier : A3P, 30 rue Pré-Gaudry – Lyon 69007
Sur place : 30 rue Pré-Gaudry, à Lyon, du lundi au vendredi

Accessibilité

Réservation hôtelière

Starling Hôtel Geneva
Route François-Peyrot 34, CH-1218 Le Grand-Saconnex
+41 22 747 02 02 / contact@shgeneva.ch
https://www.shgeneva.com/fr/

Mövenpick Hotel Geneva
Route de Pré-Bois 20, CH-1215 Genève
+41 22 717 11 11 / hotel.geneva.airport@movenpick.com
https://www.movenpick.com/fr/europe/switzerland/geneva/hotel-geneva/overview/

Crowne Plaza Geneva
Avenue Louis-Casaï 75-77, CH-1216 Genève
+41 22 710 30 00 / GVACP.info@ihg.com
http://www.cpgva.ch/