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

Critical Quality Attributes : an overview
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

Multidimensional liquid chromatography-mass spectrometry for fully automated assessment of multiple attributes of monoclonal antibodies
RIC group Koen Sandra

Koen Sandra
CEO
RIC group, Belgium

QbD: case study and lessons learnt
F. Hoffmann-La Roche Ltd. Kowid Ho

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

Measure, Understand, Control, Improve: How PAT knowledge management utilises CQAs to enhance bioproduction and support digital transformation
Optimal Industrial Technologies Michel Sachpekidis

Michel Sachpekidis
Business Development Manager
Optimal Industrial Technologies

Accelerated development strategies for release of vaccines, biopharmaceuticals & gene/cell therapy product
SGS Philippe Grimm

Philippe Grimm
Business Development & Marketing Director
SGS

How AI/ML and continuous manufacturing technologies can support biologics pipeline from discovery to BLA
Just Evotec Christelle Dagoneau

Christelle Dagoneau
VP, Global Biologics Business Development
Just Evotec

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

Challenges in Analytic for Viral Vector Manufacturing in Cell & Gene Therapy
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

Consideration of Quality by Design (QbD) Principles to Review Potential Design Spaces for Use of Sterilizing Grade Filters in Adeno Associated Viruses (AAV) Processes
PALL Emmanuelle Cameau

Emmanuelle Cameau
Strategic Technology Partnership Leader
PALL

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 alternative -sourcing project to ensure Business Continuity
Novartis Thibault Lasgouzes

Thibault Lasgouzes
Downstream Process Expert 2
Novartis

Enhanced Process Characterization by Monte-Carlo Simulations: From a local to a global understanding of the process
MERCK Pierre Moretti

Pierre Moretti
Director - Head of BPS process design
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

The Importance of Consistent Cell Count & Viability for Development & Manufacturing
Chemometec Yolla German

Yolla German
Field Application Scientist
Chemometec

Croda Pharma – High Purity Excipients for Biopharmaceutical Formulations and Bioprocessing
Croda Pharma William Small

William Small
Research & Technology Specialist
Croda Pharma

Intelligent cold chain solution
Cell&Co Florent Belon

Florent Belon
CEO - Co-Founder - Commercial Director
Cell&Co, France

Introducing VectorBuilder
VectorBuilder Auguste Attenot

Auguste Attenot
VectorBuilder

16h40

Coffee Break – Exhibition Hall – B2B Meetings

17h10

Breakthrough Innovations in Bioproduction

GenSensor: genomic based Process Analytical Technology to monitor expression systems and 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

Innovative Rapid Immunoassay for At-line monitoring of Active Product Ingredient: Application to monoclonal antibody titration
MagIA Diagnostics Paul Kauffmann

Paul Kauffmann
President
MagIA Diagnostics

17h50

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

Sartorius Eric Kummer

Eric Kummer
Head Of Operations BPS
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

9h00

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

Early identification of producing cells to support efficient clone library 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 Amina Cherif

Amina Cherif Louazani
Viral Safety Manager
Pathoquest

Increase your bioproduction efficiency with characterization of ‘Engineered cells’ using Genomic Vision’s technology
Genomic Vision Cyndie Forestier

Cyndie Forestier
Scientific Account Manager
Genomic Vision

Development of an Extracellular Vesicles production platform
Celonic Quentin Ueberschlag

Quentin Ueberschlag
Senior Scientist
Celonic, Switzerland

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

Evaluation of pulsed light technology as a new viral inactivation technology for vaccine processes
Sanofi Eric Forma

Eric Forma
DSP Principal Scientist – Global Bioprocess Development
Sanofi

Sanofi Fabien Barbirato

Fabien Barbirato
mRNA Techno Platform CMC Leader
Sanofi

Sanofi Anne Fournillier

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

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

Characterization and inactivation of endogenous retroviruses in CHO cells
Lonza Sandra Bosshard

Sandra Bosshard
Team Lead - cell Culture Development
Lonza, Switzerland

Viral clearance in downstream processing of viral vectors
Sartorius Maja Leskovec

Maja Leskovec
Head of PC3 Process Development Viruses
Sartorius

10h20

Coffee Break – Exhibition Hall – B2B Meetings

11h00

Parallell Workshops

Workshop 1 : Quality by Design & Successful scale-up
Pall
Workshop 2 : Functional Cell-based Bioassays for Biologics development
Promega
Workshop 3 : Collaborative Engineering: Needs and Challenges in developing automation solutions for Life Sciences applications
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

14h15

Title to be announced

Title to be announced
Sanofi Xavier Berthet

Jacques Volkmann
Vice President, Sanofi R&D France et Président France Biolead
France

14h30

Keynote Lecture

Opportunities for European Biotechs in Africa
Institut Pasteur de Dakar au Sénégal Xavier Berthet

Xavier Berthet
Director - Biomedical Research
Institut Pasteur de Dakar, Sénégal

15h00

Breakthrough Innovations in Bioproduction

Building an innovative platform for continuous manufacturing and realtime release of monoclonal antibodies
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

Accelerate Innovation and Improve Productivity
thermofisher Alexandre Callot

Alexandre Callot
Senior Technical Sales Specialist
ThermoFisher

The new generation of microcarriers for high cell culture performance
Carroucell Tarek Fathallah

Tarek Fathallah
CEO
Carroucell

Microalgae Extracellular Vesicles: an effective drug delivery system for therapeutics and vaccines.
AGS Manuel Vega

Manuel Vega
Founder CEO
AGS, France

15h35

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

SANOFI Nicolas Chaudet

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

How to remove the barriers to making mRNA-based vaccines & therapeutics, from multiple preclinical constructs to commercial production
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

A lentiviral platform for efficient and safe RNA delivery
Flash Therapeutics Pascale Bouillé

Pascale Bouillé
CEO
Flash Therapeutics, France

16h55

Closing remarks

17h00

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