A3P

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31st May & June 1 2017st - Lyon (FR)
Conferences, Workshops, Exhibition, Plant Tour
bioproduction Efficiency

Over the past decade, biomanufacturing HAS Become a strategic driver to scalable and flexible operations, controlled costs. The advances in manufacturing technology-In Particular continuous manufacturing, process analytical technology, single-use systems, alternative technical downprocessing lead to Improve the efficiency of the processes Contributing to cost reduction qui Becomes a challenge for all the drug makers.

In the upcoming Biomanufacturing A3P CONGRESS, You will-have the opportunity to learn about key trends, methodologies and insights on manufacturing, process development, quality management and compliance of bioproducts.

WHO WILL YOU MEET
Network with senior VPs, Heads, Directors, Managers and decision makers of leading biopharmaceutical and biotech companies Whose Responsibilities include Manufacturing, Process Development, Bioprocessing, Cell Culture Manufacturing, Technical Operations, Process Excellence, Quality, Validation, Outsourcing and Regulatory.

 

REGISTRATION
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EXHIBITION
Book your booth //Exhibitors' List
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PROGRAM - 31st May & June 1st 2017
International City, 50 Quai Charles de Gaulle, 69463 Lyon (FR)

   
  CONFERENCES
May 31st
09: 00 - 13: 00
 

WHO GMP for biological products - Major learnings
WHO - Mustapha CHAFAI

A pro-efficient methodology for rapid scale-up of mAbs to Manufacturing Upstream Processing
LFB biomanufacturing - Abdel Zemmar

The challenges of Developing a high concentration monoclonal antibody product
SANOFI - Antoine ALARCON

Bioformulation for the future: new Alternative Approaches are emerging, based on Gained experience over the last years 20 in Developing monoclonal antibody biotherapeutics
NOVARTIS - Otmane BOUSSIF

Bioburden Body of Knowledge (BooK) for Drug Substance processes: turning lessons learned into action!
Sanofi Pasteur - José Guillermo ALBANESI

How to accomplish achieve high as recombinant expression in mammalian cells?
AMPLYCELL - Geoffrey HOLSBEEK

   
           
  WORKSHOPS
May 31st
14: 30 - 18: 30

1 - Implementation and Validation of a Single Use mixing step for virus clearance
LFB & SARTORIUS
LFB HAS recently Invested in additional generation capacity and is Establishing a single-use generation platform for the manufacture of monoclonal antibodies comprenant un virus inactivation step. LFB thing single-use mixing bags over stainless steel tanks Because They operate a multi-product facility using product-dedicated virus inactivation vessels. Using single-use mixers therefore decreases the investment required to purchase through HAVING and validate a cleaning procedure for multiple stainless steel mixers. Numerous testing (chemical compatibility and leachable studies film adsorption, mixing homogeneity)-have-been Performed to Demonstrate the applicability of single-use mixing technology for a virus inactivation step.

2 - How pour augmenter the quality without Affecting the validation process? Case study: Cell Culture Automation from embryos  
GSK WOW & TECHNOLOGY
In this workshop, you will experience how to manage the innovation in your sector by Improving the quality Without Any compromise on the validation of the process. Our case study, based on the automation of the cell from growing embryos and used in MMR vaccine production will give you guidelines to move the hand forward and apply Them Directly to your specific projects.

3 - Evaluation and decision criteria for Single Use Implementation in Bioproduction 
VIRBAC & THERMOFISHER
Single Use Systems (SUS) are Significantly Developing in order to meet the industry needs and requests. The advantages are Well Known: ease of use and implementation, Decrease in cleaning validation efforts, flexibility, limited CAPEX as Compared to conventional systems ...
Nevertheless, Many criteria need to be Evaluated before Implementing SUS in order to Ensure Success. During this workshop, we will invite you to take the role of a project manager in order to map the different steps and criteria for the implementation of a Single Use Process. In a second stage, we will select 2 major topics and explores em in details. The goal of the workshop is to give participants an effective approach in the assessment of Single Use System projects.

4 - Risk analysis in industrial biotech process development, robustness and consistency Production Run
DEBIOPHARM & ABCONSULTING
In the pharmaceutical industry, risk management HAS Become a routine approach to the assessment of unexpected events Affecting quality, safety and performance of products and manufacturing processes Ensuring, Ultimately, optimal protection of the patient. Regulators expect That risk management is inherently built into the quality management systems of the pharmaceutical companies by using Both formal and informal risk tools (see ICH Q8-9-10). This workshop will aim to first and Quickly review the different guidelines, and can definitons tools. Then, the key principles will be applied in practical case studies in small size working groups. In dissertation case studies, the participants will be faced with real-life management of Risks in different business scenarios and Will Be Asked to analyze the status and provides a sound risk management strategy and execution. The last portion of the workshop will be Devoted to sharing the outcomes of the different groups and how the Proposed solutions.

5 - Stabilization of the solution in broad molecules from the development to the fill & finish
UNITHER DISPOSABLE LAB & PHARMA
More than 50% of the new drugs coming from the biotech nonstable are in solution and require a freeze-drying form. Some technologies are available on the market and some new are under development.

The goal of this workshop is The Following:
- Describe the different technologies applied to Stabilize In Some molecules wide solution
- The Application for Drug Substance (DS) and Drug Product (DP). Biodisponibility, pharmaceutical form, side effects ...

- Compares a process and steps for a freeze dry form and a liquid injectable form for a small batch and what are the Advantages and disadvantages. Sterilization, handling, formulation, cost ...
- The fill & finish solution for small batches as disposable isolator, RTU materials (Vials, stop ....) and the regulatory rules
- In term of filling solution what are the technology to fill small volume as required in icts Many gene therapy fields (0, 1 0 gold 2 ml)?

The Workshop Will Be Performed around a Process Chart qui olefins the steps and choices using the experience of the participants and is based 2 case studies from the DS to the DP Including technology, safety, cost ...
- Freeze dry form
- Liquid form

This workshop will expect people from the development, formulation and clinical phases

   
           
  CONFERENCES
1st June
08: 30 - 12: 00
 

Management of Economics in Biopharma Production, Opportunities Myths & Reality
GE - Guenter JAGSCHIES

Flexible & cost effective biotech GMP facility: Testimony after-5 years' experience
MERCK BIODEV - Nicolas BELLEGARDE

Biopharmaceutical Increase efficiency and safety with the addition of an integrity testing step
Zoetis - Fabien DEBRAS

Clarifying the gap entre upstream and downstream - Application of technologies to clarification of harvested mammalian cell cultivation 
Allergan BIOLOGICS - Christopher WILSON

Integrating Human Performance Principles into BioPharma Operations
Lonza - Michael MOEDLER

   
         
    TOUR PLANTS - 1st June - 13: 15 // 17: 30    
  acCInov logo  

AcCInov
AcCInov is a biomanufacturing center and Provides biotech, pharma and medtech companies with state of the art R & D laboratories (BSL2), cleanrooms (ISO 8-7), GMP manufacturing pilot units & tailored solutions for quality assurance & pharmaceutical carrier to boost Their projects, keep internally Their know-how and Their IP & manage Their facilities in the MOST flexible way. AcCInov's customers-have to just plug & play Their projects in a full ISO / GMP compliant environment. AcCInov HAS HAD pharmaceutical establishment status since September 2014 80 and hosts more than one person site, 15 companies and projects, Including experimental new drugs Production projects.

The afternoon will start with a presentation of the Do-it-yourself model for GMP manufacturing biologics manufacturing through a real case study of an experimental drug Developed at acCInov.After the presentation, acCInov's team will invite you for a tour to discover the website GMP pilot units dedicated to cell banks, biological drug substances, non-sterile & sterile drugs production.During the visit, you will aussi learn more about the innovative projects hosted in the biomanufacturing center.

   
  biomerieux logo   BIOMERIEUX
Craponne is bioMérieux Major Site for Culture media manufacturing and the Largest in Europe: more than 130 million Petri dishes and 20 million tubes & bottles are Produced every year, the website aussi Provides ready-to-use Deshydrated Culture Media to l'autre manufacturing sites.
Referring to the pharmaceutical business, 30 Millions of plates are Produced in Craponne. The website is Indeed the place Where the 3P ranks of pharmaceutical cultivation media for environmental monitoring Was Developed and Produced est Currently, with the standard available in the Highest The field of media culture.
Considering this core portion of our activity, the brand new pharma-dedicated area, Petri 3, 2015 in lancé allowed us to duplicate our ranks 3P manufacturing capacity.
The visit will be Organized around 4 complementary workshops:
  • global site presentation (classroom)
  • Petri 3 area visit (remote controlled high resolution camera system)
  • Tubes & Bottles area visit (remote controlled camera system)
  • Quality Control lab visit (on the shop floor)

 

   
 

 

Sanofi logo genzyme

 

GENZYME SANOFI 
This Sanofi Genzyme manufacturing site, based in the Biodistrict of Gerland, is Specialized in bioproduction and immunology. It est aussi a reference in terms of environmental protection.
The Lyon website manufactures, for 68 countries, polyclonal antibodies used to treat graft rejection and prevent prevention During transplants and in hematology. The team is in charged of the management of all bio-materials, purification of the immune serum and the release of the active pharmaceutical ingredient.
Since 2015, the website diversified activity icts with the implementation of a viral vector manufacturing platform qui Represented an investment of 10 million euros financement Equally by Sanofi and Transgene (partnership signed in 2013). This platform will enable generation of a new therapeutic class of active ingredients (viral vectors) and will be made available to outside customers as well as for internal needs.

During the visit, you will-have a presentation of the website activities and get to visit our premises, Including Both manufacturing platforms.

   
     

 


 

partners:
mabdesign    BioAlps  BIOWIN

 

   

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