Bioproduction Congress 2022

CMC Readiness to accelerate
biotherapeutics for patients

Agenda

Day 1

Thursday, 29 September 2022

12h20

Registration

12h50

Welcome Address

13h00

Opening Keynote Lecture

Merck-Serono SA Hervé Broly

Hervé Broly
Executive CMC Consultant for Biologics
Merck-Serono SA, Switzerland

13h30

Coffee Break – Exhibition Hall – B2B Meetings

14h00

Track Reassessing Critical quality attributes (CQA ) for mAbs & Vaccines : latest developments

Risk-based control strategies of recombinant mAb variants during development
Pierre Fabre Alain Beck

Alain Beck
Senior Director, Biologics CMC & Developability
Pierre Fabre, France
Associate editor
mAbs

3D-LC-MS with 2D multi-method option for fully automated assessment of multiple attributes of monoclonal antibodies directly from cell culture supernatants
RIC group Koen Sandra

Koen Sandra
CEO
RIC group, Belgium

F. Hoffmann-La Roche Ltd. Kowid Ho

Kowid Ho
Technical Regulatory (CMC) Policy Biologics
F. Hoffmann-La Roche Ltd., Switzerland

Track Critical quality attributes (CQA) for Cell & Gene Therapy : new advancements

Yposkesi Olivier Maurion

Olivier Maurion
Director « GoCommercial » Project
Yposkesi, France

Defining CQAs for Cell Based Medicinal Products– The CMC building blocks
Voisin Consulting François Gianelli

François Gianelli
Senior Director CMC
Voisin Consulting Life Sciences

Definition and assessment of quality attributes of a recombinant adeno-associated virus-based gene therapy product
UCB Pharma Michel Degueldre

Michel Degueldre
Lead GT Analytics Physico-Chemical methods
UCB Pharma, Belgium

Real-time monitoring of cell quality attributes drives process intensification in cell and gene therapy
MERCK Antoine Heron

Antoine Heron
Cell & Gene Therapy Bioprocessing
Merck, France

15h20

Track Process characterization and validation for mAbs and Vaccins : case-studies

Impact of manganese in media components on monoclonal antibodies, lessons learned from dual sourcing & risk mitigation
SANOFI Elodie Lim

Elodie Lim
Upstream Process Engineer
SANOFI

SANOFI Marine De-Jaeger

Marine De-Jaeger
USP Engineer
SANOFI

Resin re-use study as part of double-sourcing project to ensure business continuity
Novartis Thibault Lasgouzes

Thibault Lasgouzes
Downstream Process Expert 2
Novartis

Use of Monte-Carlo simulations to check the appropriateness of process parameter acceptable ranges
MERCK Jérôme King

Jérôme King
Senior Scientist
MERCK, Switzerland

Use of transcriptomic approach to characterize a cell line used for vaccines production
SANOFI Léa Bourigault

Léa Bourigault
Upstream process PhD student
SANOFI, France

Track Process characterization and validation for cell & gene therapy : case-studies

Addressing AAV manufacturing challenges
Celonic Gregory Berger

Gregory Berger
Principal Scientist Cell & Gene Therapy
Celonic, Switzerland

Process Characterization for Viral Vectors: a lifecycle approach in CDMO context
ABL Guillaume Sirgue

Guillaume Sirgue
Head of BioManufacturing and Process Development Operations
ABL Europe Lyon

16h40

Coffee Break – Exhibition Hall – B2B Meetings

17h10

Breakthrough Innovations in Bioproduction

GenSensor Charles Hébert

Charles Hébert
CEO
GenSensor

Innovative scale-up of adherent cells with Pall Multiplate bioreactor Xpansion® coupled with a Ksep® fluidized cell bed centrifuge
Bio Elpida Elodie Paquier

Elodie Paquier
R&D Director
Bio Elpida, France

The challenges of bioengineered extracellular vesicles to develop of biotherapeutic and vaccines
Ciloa Robert Mamoun

Robert Mamoun
CEO and co-founder
Ciloa, France

Mid-infrared spectroscopy to monitor excipients and protein concentration in downstream processing
IRUBIS GmbH Anja Müller

Anja Müller
Managing Director
IRUBIS GmbH, Germany

17h50

Round table: How to bring single-use disposables and consumables suppliers back to Europe: challenges & opportunites

Sartorius Philippe Gomez

Philippe Gomez
Key Account Manager
Sartorius, France

Merck Eva Schaefer

Eva Schaefer
Director Supply Robustness
Merck KGaA, Germany

LFB Biomanufacturing Roland Beliard

Roland Beliard
CEO
LFB Biomanufacturing, France

19h00

Poster presentation- Exhibition Hall – Apero Cocktail

Day 2

Friday, 30 September 2022

8h00

Welcome coffee

8h30

Opening Keynote Lecture

Opportunities for European Biotechs in Africa
Institut Pasteur de Dakar au Sénégal Amadou Sall

Dr. Amadou SALL
CEO
Institut Pasteur de Dakar, Sénégal

9h00

Track Stability studies of cell lines to speed up first in human trials: new technologies & approaches

Use of high advanced technologies to support an efficient cell line generation
Merck Julien Douet

Julien Douet
Head Cell Line Technologies
Merck

Human mesenchymal stem cells for production of extracellular vesicles
Evercyte Regina Grillari

Regina Grillari
COO, CSO, co-founder
Evercyte

RNA Next-generation Sequencing Transcriptomics Analysis
Pathoquest



Pathoquest

Track Viral Clearance in the Manufacture of Biologics: next generation strategies

Sanofi Pasteur Eric Forma

Eric Forma
Scientist - Deputy Head of a Bioprocess Research & Development Unit
Sanofi Pasteur

Sanofi Pasteur Fabien Barbirato

Fabien Barbirato
mRNA Techno Platform CMC Leader
Sanofi Pasteur

Sanofi Pasteur Anne Fournillier

Anne Fournillier
Head of CMC Life Cycle Management, Pediatric and Booster vaccines
Sanofi Pasteur

Next generation sequencing as an alternative tool for the detection of potential viruses during the production of biotherapeutics
MERCK Cristina Barbirato

Cristina Barbirato
Scientific and Regulatory Expert for Biological Quality Control - Senior Scientist
Merck

ERV removal in CHO cells
Lonza Sandra Bosshard

Sandra Bosshard
Team Lead - cell Culture Development
Lonza, Switzerland

10h20

Coffee Break – Exhibition Hall – B2B Meetings

11h00

Parallell Workshops

Workshop 1
Pall
Workshop 2 : Functional Cell-based Bioassays for Biologics development
Promega
Workshop 3
Festo
Workshop 4 : Choose the right strategy and the right partner for innovative therapies manufacturing : Return of experience & case studies of CMC leaders of biotech start-ups & pharma companies
ABL

12h30

Lunch– Exhibition Hall – B2B Meetings

14h30

Breakthrough Innovations in Bioproduction

Bioproduction
simAbs Koen Dierckx

Koen Dierckx
co-founder and CEO
simAbs, Belgium

Evaluation of the impact of hydrodynamic stress on DuckCelt®-T17 avian cell growth in a 3L-bioreactor via dynamic OUR analysis
Université Claude Bernard Lyon 1, France Valentine Tingaud

Valentine Tingaud
PhD Student Process Development
Université Claude Bernard Lyon 1, France

A rational methodology for the assessment and optimization of a fill & finish mAb filtration step based on the GPX® approach
Ypso-Facto Agnès Corbin

Agnès Corbin
Business Development Manager
Ypso-Facto, France

Development of an Extracellular Vesicles production platform
Celonic Quentin Ueberschlag

Quentin Ueberschlag
Senior Scientist
Celonic, Switzerland

15h05

Track mRNA, a new platform technology and therapeutical approach: pros & cons

SANOFI Pasteur Nicolas Chaudet

Nicolas Chaudet
Bioprocess R&D Unit head (microbiology / mRNA)
SANOFI Pasteur

Quantoom Biosciences Jose Castillo

Jose Castillo
CEO
Quantoom Biosciences

New platform platform technology and therapeutic approach – the CDMO and the client perspective
Celonic Arslan Akmammedov

Arslan Akmammedov
Principal Scientist
Celonic

Flash Therapeutics Pascale Bouillé

Pascale Bouillé
CEO
Flash Therapeutics, France

16h30

Closing remarks

16h40

Exhibition Hall – B2B Meetings

18h00

End of Congress

Call for Abstracts for Pitch/Poster

Submit your Abstract to give a Pitch presentation or present your Poster at the 7th edition Bioproduction Congress.

In order to provide visibility and promote innovation in the field of “CMC Readiness to accelerate biotherapeutics for patients”, a call is open to submit an abstract for a Pitch at Breakthrough Innovations in Bioproduction Session.
This is a great opportunity for start-ups, SMEs, and academic laboratories to share their new work!

The abstracts will be reviewed and the best selected for innovative products, technology, approaches and research.

Abstract submission deadline extended: July 29th, 2022

Check out the guidelines and fill-in the Abstract Form and send it to ana-sofia.antunes@mabdesign.fr
Abstract Submission Guidelines Abstract Form

Organization contact