A3P in Italy - Single Use
Regulatory / Risk Assessment / Validation / Leachables & Extractables

Place

Courtyard by Marriott Rome Central Park in Rome

Date

14 March 2019

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Format

Conferences, exhibition, partner sessions

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Single-use systems (SUS) are developing considerably to meet the needs of the industry: ease and speed of implementation, response to cleaning validation issues and flexibility are just some of the strengths of these systems.

The implementation of these systems requires in-depth analysis on various topics, including:

Quality: extractable / leachable, container-content interactions, system integrity, material quality control, process validation.

Technologies : disposable probes, interface and interconnection with conventional equipment, physical limitations of SUS (flow, pressure), control / monitoring systems.

Environment: how to integrate these systems into sustainable development and minimize environmental impact programs?

Supply: How to ensure security of supply throughout the production chain, from the raw material used for the production of polymers to the delivery of the SUS to the end customer? Is it possible to develop standards to implement dual sourcing?

Economic : comparison of the costs of installation and operation of SUS systems with conventional systems, control of cost evolution, regulatory changes, in particular on the initial and continuous validation of these technologies.

During this day you will have the opportunity to explore the topics listed above with industry experts and discuss concrete issues with them through lectures and hands-on workshops.

Come participate in this event!

Official language of conferences: Italian
Simultaneous translation of conferences: Italian <-> English

Thursday March 14

Welcome of participants
08:15
Regulatory watch and generic validation approach
Katell MIGNOT - SARTORIUS
09:00
security of supply in single use
Geoffroy MALHERBE - THERMO FISHER
09:30
Coffee break - Visit of the exhibition
10:00
Partner Sessions Part 1 See the details of the sessions
MEISSNER - PALL BIOTECH - SARTORIUS - THERMO FISHER SCIENTIFIC
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
11:00
Partner Sessions Part 2 See the details of the sessions
MEISSNER - PALL BIOTECH - SARTORIUS - THERMO FISHER SCIENTIFIC
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
12:00
Lunch - Visit of the exhibition
13:00
Single Use material experience from an aseptic fill & finish CMO
Enrico ZANETTI - SWISSFILLON
14:30
Analytical challenges associated with leachables in Biopharmaceutical production
Andreas NIXDORF - SGS
15:00
Coffee break - Visit of the exhibition
15:45
Single-use systems particulates risk management
Patrick EVRARD - PALL
16:15
Security of Supply - Evaluating Survey Input from Industry Suppliers
Brigitte DELAPLACE - MEISSNER
16:45
Conclusion of the day
17:00
How Client Collaboration Fosters Innovation: A closer look at the evolving portfolios for single-use fill & finish assemblies, modular overmolding for enhanced connectivity and security, and a scalable, single-use freeze and thaw platform for biopharmaceuticals
Thomas VANDROMME - MEISSNER
Meissner Filtration Products, as an organization, prides itself on being responsive and able to translate customer needs into synergistic future innovations. During this presentation, we will focus on several examples of this synergistic materialization in the development of the following product portfolios: BioLink ™ Modular Overmolding, CryoVault ™ Freeze and Thaw Platform for Bulk Drug Substance, and Single-Use Fill & Finish Assemblies. Meissner will discuss multiple input constrains, the impact of these ideas on the design process, and the choice of which one has been chosen for development. Aspects that will be addressed during the design process, and will include the following: Finally, we will explore the considerations taken into account, while focusing on the selected materials of construction, the essence of each portfolio's modular design, and how these features work in combination to deliver unique advantages to biopharmaceutical processing. Mitigation of the number of single fluid contact materials, and the expansion of the applicable design space will be covered, as they were crucial factors in the development of the product portfolios.
1 workshop
Implementing a single-use facility: how to ensure reliability and robustness?
Marco SANVITO - PALL BIOTECH
Implementing a single-use facility: from the user's requirement specification to the selection of the solution - how to ensure reliability and robustness? In this workshop participants will define the key steps in the project, best suited for the choice of the most appropriate solution. A new interactive tool for the design of single-use solutions will be demonstrated
2 workshop
How to insure best robustness along with all process steps while decreasing validation costs and change control when using single-use systems?
Miriam LAVIE - SARTORIUS
Our scalable FlexSafe® platform has already demonstrated its growth, robustness, integrity and ease of use for cell culture, liquid storage and shipping applications. Mixing and Large Volume Storage is now part of the Flexsafe® family and supplements the Flexsafe® platform for upstream, downstream and final formulation. By using Flexsafe® storage and mixing solutions, the end-user can benefit from most advanced film technology, and can provide reproducible performance, and long term supply. This is the implementation of the process and reduces the time and the cost for the validation process, and change control management.
3 Workshop - Part 1
Single Use vs Stainless Steel Challenge: Which way to bet for Final Filling Operations?
Benoit DI MARINO - SARTORIUS
When 15 years ago, I do not know what I mean in the field of Final Filling, what is the status today? Despite the criticality of this application, the constant evolution of single use technologies has made it possible to meet the challenge of performance and patient safety. This presentation compares traditional Stainless Steel (SS) and SUS used for final filling operations. Key figures and elements will be used to address the main topics like performance dosing, productivity, validation and logistic aspects, etc.
3 Workshop - Part 2
Bioproduction liquids
THERMO FISHER SCIENTIFIC
Media, buffers and different types of water are the basis of any bioprocess. Choosing between an in-house preparation strategy or outsourcing is a fundamental choice. In this workshop, discover and put into practice costing solutions, developed without bias by a leader able to provide all the scenarios. The impact of batch sizes of solutions will be particularly considered, with the appropriate technologies to optimize costs.
4 Workshop - Part 1
Reduce the risks associated with single-use technologies
THERMO FISHER SCIENTIFIC
Any single-use or multiple-use technology is associated with risks, which often differ greatly. This interactive workshop welcomes you to come and share concrete and effective solutions to reduce the most important risks in the implementation of single-use technologies, such as integrity assurance, security of supply, cost drift operational, particles, endotoxins. Risks more specifically related to single-use mammalian or microbial cell culture will also be addressed, such as surface hypoxia, foam, overpressures and their causes.
4 Workshop - Part 2

You wish to reserve a stand, please consult our exhibitor file

Access the Exhibitor Registration Form

Plan of the exhibition

SociétéN° StandSociétéN° Stand
 ASSOCIATES OF CAPE COD1KROHNE6
 PROMEPLA2ROMMELAG ENGINEERING7
 SGS3PALL BIOTECH (partner)8
4 SARTORIUS (partner)9
 THERMO FISHER SCIENTIFIC (partner)5 MEISSNER (partner)10

Benefits included with the Table Top

  • A dedicated exhibition space on which you can install your products and communication tools: umbrella stand, roll-up, display, product, ... A basic endowment including table 180 × 80 cm, 2 chairs and 1 electrical connection (2kw ) without protection circuit breaker
  • Breaks and meals indicated in the program
  • Unlimited WiFi
  • A badge that allows you free access to the entire technical and scientific program
  • List of participants in the event
  • Ability to register an additional person at the special rate "accompanying" (500 € HT)
[Registration Form3psingleuseitaly not found!]

Contact

For more information, please contact Natalina SEMEDO:

Phone: +33 (0)4 37 28 30 52
Fax: +33 (0)4 37 28 30 60
E-mail : Natalina Semedo
Mail: A3P, 30 rue Pré-Gaudry - Lyon 69007

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