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logo congress bioproduction2015

31st May & 1st June 2017 - 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 technologies–in particular continuous manufacturing, process analytical technology, single-use systems, alternative downprocessing techniques lead to improve the efficiency of the processes contributing to cost reduction which 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
Fees
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EXHIBITION
Book your stand // Exhibitors' List
picto stand

  

     
PROGRAMME - 31st May & 1st June 2017
Cité Internationale, 50 Quai Charles de Gaulle, 69463 Lyon (FR)

   
  CONFERENCES
31st May
09:00 - 13:00
 

WHO GMP for biological products – major learnings
WHO - Mustapha CHAFAI

A pro-efficient methodology for rapid scale-up of mAbs Upstream Processing to Manufacturing
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 20 years in developing monoclonal antibody biotherapeutics
NOVARTIS - Pamela DE MOOR

Biocontamination Body of Knowledge (BooK) for Drug Substance processes: turning lessons learned into action !
SANOFI PASTEUR - Guillermo José ALBANESI

How to  achieve high titre expression in recombinant mammalian cells?
AMPLYCELL - Julien ISOARD

   
           
  WORKSHOPS
31st May
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 production capacity and is establishing a single-use production platform for the manufacture of monoclonal antibodies including a virus inactivation step. LFB chose 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 through having to purchase 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 to increase the quality without affecting the process validation? 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 culture from embryos and used in MMR vaccine production, will give you the main guidelines to move forward and directly apply them 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 effort, 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 phase, we will select 2 important topics and explore them 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 evaluation 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, definitons and possible tools. Then, the key principles will be applied in practical case studies in small size working groups. In these case studies, the participants will be faced with real-life management of risks in different business scenarios and will be asked to analyse the situation and propose a sound risk management strategy and execution. The last part of the workshop will be devoted to sharing the outcomes of the different groups and comment the proposed solutions.

5 - Stabilization in solution of the large molecules from the development to the fill & finish
UNITHER PHARMA & DISPOSABLE LAB
More than 50% of the new drugs coming from the biotech are nonstable 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 solution some large molecules
- The application for Drug Substance (DS) and Drug Product (DP). Biodisponibility, pharmaceutical form, side effects...

- Compare 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, stopper....) and the regulatory rules
- In term of filling solution what are the technology to fill small volume as its required in many gene therapy fields (0, 1 or 0, 2 mL)?

The workshop will be performed around a Process Chart which defines the steps and choices using the experience of the participant and based on 2 case studies from the DS to the DP including technology, safety, cost...
- Freeze dry form
- Liquid form

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

   
           
  CONFERENCES
1st June
08:30 - 12:00
 

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

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

Increase Bioproduction efficiency and safety with the addition of an integrity testing step
ZOETIS - Fabien DEBRAS

Clarifying the gap between upstream and downstream - Application of technologies to clarification of harvested mammalian cell culture 
ALLERGAN BIOLOGICS - Christopher WILSON

Integrating Human Performance Principles into BioPharma Operations
LONZA - Michael MOEDLER

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

ACCINOV
Accinov is a biomanufacturing centre 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 support to boost their projects, keep internally their know-how and their IP & manage their facilities in the most flexible way. Accinov’s customers have just to plug their projects & play in a full ISO/GMP compliant environment. Accinov has had pharmaceutical establishment status since September 2014 and hosts more than 80 person on site, 15 companies and projects, including experimental new drugs production projects.

The afternoon will start with a presentation of the Do-it-yourself GMP manufacturing model for 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 site tour to discover the GMP pilot units dedicated to cell banks, biological drug substances & non-sterile & sterile drugs production. During the visit, you will also learn more about the innovative projects hosted in the biomanufacturing center.

   
  logo biomerieux   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 site also provides ready-to-use Deshydrated Culture Media to the other manufacturing sites.
Referring to the pharmaceutical business, 30 Millions of plates are produced in Craponne. The site is indeed the place where the 3P range of pharmaceutical culture media for environmental monitoring was developed and is currently produced, with the highest standard available in the field of culture media.
Considering this core part of our activity, the brand new pharma-dedicated area, Petri 3, launched in 2015 allowed us to double our 3P range manufacturing capacity.
The visit will be organized around 4 complementary workshops:
  • Site global 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)

 

   
 

 

logo sanofi genzyme

 

SANOFI GENZYME (Full) 
This Sanofi Genzyme manufacturing site, based in the Biodistrict of Gerland, is specialized in bioproduction and immunology. It is also a reference in terms of environmental protection.
The Lyon site manufactures, for 68 countries, polyclonal antibodies used to prevent and treat graft rejection during transplants and in hematology. The team is in charge of the management of all bio-materials, purification of the immune serum and the pharmaceutical release of the active ingredient.
Since 2015, the site diversified its activity with the implementation of a viral vector manufacturing platform which represented an investment of 10 million euros, financed equally by Sanofi and Transgene (partnership signed in 2013). This platform will enable production 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 site activities and get to visit our premises, including both manufacturing platforms.

   
     

 


 

Partners:
mabdesign    bioalps  biowin

 

   

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