Online MasterClass 16-18 October, 2023

Cell & Gene Therapy

MasterClass - with
focus on viral vectors
- EU edition

Lars Brandén

LEARNING OUTCOMES:

• LEARN about the ability of viruses to integrate with

the host genome and insert viral DNA engineering of
viruses, so they become integrative but non-replicative.
• DISCUSS plasmid design growth in HEK293 cells and
expansion to reach desired titration
• EXPLORE the difference in how VV are used in gene-
modified cell therapy and gene therapy (GMCT)
• TALK ABOUT host cell protein requirements
• ANALYSE purifications techniques/analytical
techniques: ELISA, qPCR, HPLC, TCID50, replication
competent lentivirus detection, QC of cell therapeutic
products (cell surface marker characterization)

www.glceurope.com
Cell & Gene Therapy MasterClass 16-18 October, 2023
- with focus on viral vectors
Online MasterClass
- EU edition

EVENT INTRODUCTION

This 3-day online course will detail the fundamental biological components for gene therapy
and gene-modified cell therapies and outline important consideration for selecting the most
appropriate vectors and specific safety aspects.

Critical biological information to enable understanding of the cell and gene therapy tools and
therapies both existing today and coming in the near future.

The course will also address key points in manufacturing, purification and different technologies
for each of the types of therapies addressed during the course.

The lack of standardization regarding modular single-use consumables will be discussed as well as
methods for cell separation and scaling-up issues.

Participants will also be given a set of case studies to analyse from the perspective of the course
and provide feedback to the course leader who will select a few for general forum viewing after
anonymizing the person providing the analysis.

WHO SHOULD ATTEND?

• Professionals in biotech
• Pharmaceutical industry
• Medtech industry
• Science reporters
• VC advisors in the life sciences
• Think-tank employees focusing on life sciences
• Senior decision makers that needs a deeper understanding of the field of cell- and gene
therapies to guide their companies into the future with a better understanding of the
underlying technologies driving much of the life science industry

www.glceurope.com booking@glceurope.com +36 11 848 05 96

848 0515
Cell & Gene Therapy MasterClass 16-18 October, 2023
- with focus on viral vectors
Online MasterClass
- EU edition

Meet the Trainer:

Dr. Lars J. Brandén

Dr. Lars J. Brandén, Linnaeus University, Sweden, Innovation Advisor and independent consultant
for pharma, biotech and medtech industry with global experience for the last 10 years and with
over 15 years experience in academic research.

Accomplished leader in Biotech R&D both in academia and industry with a solid background in
cell- and gene therapy as well as in Bioinformatics, HTS, phenotypic screening and cell-based assay
development. Successfully built and operated two cutting edge High Throughput Cell Biology
centres from ground and up with industry-scale capacity.

• Innovative approach to developing new technologies and new applications.

• Strong background in design, implementation, and applications development for new
technology.

After receiving his PhD from the Karolinska Institute, Sweden Dr. Brandén was recruited to three
senior director positions at Columbia University and Yale university and also as post-doctoral research
fellow at Memorial Sloan-Kettering Cancer Center, MSKCC. Dr. Brandén has also worked as the senior
director for Bioinformatics for an UK clinical company as well for several global pharmaceutical,
biotech and medtech companies.

Areas of expertise with hands-on experience for each area:

• Virology
• Immunology
• Cell signalling
• Gene and Cell Therapy
• Bioinformatics
• Systems Biology
• Drug discovery process
• Laboratory automation

www.glceurope.com booking@glceurope.com +36 11 848 05 96

848 0515
Cell & Gene Therapy MasterClass 16-18 October, 2023
- with focus on viral vectors
Online MasterClass
- EU edition

We reserve the right to make slight adjustment in the training program

DAY1 DAY2

08:55 Connecting to the Online MasterClass
09:00 Session 1:
Understanding underlying
virology and cell biology
Explain the wide variety of virus types and how
this can be utilized to choose the best virus for the
application and also the ability to use the native
targeting ability for some virus types. Describe the
development of the different GT viruses that has
been and are used today. What virus is good for
some and not for other applications with details on
the genetics and infectious cycle of example virus
types to illustrate the reasons. The following will
be considered:
• The ability of viruses to integrate with
the host genome and insert viral DNA
• Engineering of viruses so they become
integrative but non-replicative in order
to ensure patient safety
• What are the viruses we use for CGT
applications: some strand of the HIV
virus which has been modified over
time, lentivirus, adenovirus etc.
• CAR-T cell therapy
10:30 Coffee Break
10:45 Session 2:
Viral Vector manufacturing and
therapeutic cell manufacturing
principles
• Elimination of bacterial DNA sequences from
plasmids and how different DNA sequences
can cause immune reactions and cell death
plus other considerations of plasmid design.
Considerations of scaling up from the lab
to the clinical scale plus media composition
and cell line considerations due to potential
contaminations causing immune reactions
when injected into patient.
• Design of production facilities with
positive pressure and strict protocols for
manufacturing etc
• Plasmid design
• Growth in HEK293 Cells and expansion
to reach desired titration, 50l, 200l
• Industrialization of cell therapies
• Understanding the different
technologies available and when
to use what.
• Facility requirements – operating in
closed systems saves time and money
as you can operate in a grade C/D
facility
12:15 Coffee Break
08:55 Connecting to the Online MasterClass
09:00 Session 4:
Choosing the most appropriate
vector for your application
• Importance of deep knowledge of the
disease to be able to design the best
therapy ie choose the right vector
system and genetic control systems for
the therapeutic genetic elements.
• Explain the difference in ex vivo and in
vivo GT and the design of the different
approaches plus discussing the use of
naked nucleic acid therapies v/s vector
based therapies.
• The difference in how VV (Viral Vectors)
are used in gene-modified cell therapy
and gene therapy – GMCT – vector is the
raw material whereas in gene therapy
the vector is the final product.
10:30 Coffee Break
10:45 Session 5:
Choosing the most appropriate
viral vector for your application
Problems with large genes and also how the
distant enhancers can cause issues in vector
design. The target cells might have a low level
of available receptors for the infection and
how this can affect the design of the therapy
and overall design.
Brainstorm common factors
which influence VV selection:
• Size of the gene which
needs to be transduced
• Transduction efficiency
• Serotype efficiency
12:15 Coffee Break
12:30 Session 6:
Group Exercise and feedback
Groups will consider important factors and
design a viral vector for their cell and gene
therapy application and feedback their
thoughts to the group.
13:30 END
End of Day2

12:30 Session 3:
Group Exercise
This will be the start of a rolling case study.
Delegates in groups will be presented with a
scenario where they develop a CGT application
which needs viral vectors for delivery or
engineering. Delegates will consolidate the
previous two sessions and consider key steps for
engineering a viral vector for their application.

13:30 END End of Day1

All dates and times are expressed in UTC/GMT+2

on the Agenda (CET Time Zone)

www.glceurope.com booking@glceurope.com +36 11 848 05 96

848 0515
Cell & Gene Therapy MasterClass 16-18 October, 2023
- with focus on viral vectors
Online MasterClass
- EU edition

We reserve the right to make slight adjustment in the training program

DAY3

08:55 Connecting to the Online MasterClass

09:00 Session 7:
Purification Requirements
Importance of use of optimal culture media and
certified producer cells. How it can be good and
bad to “push” a producer cell line to high titters
as it can be causing an issue with empty v/s full
capsids. Discuss how bacterial and producer cell
DNA can cause negative effects as well as other
impurities from manufacturing.
• Host cell protein requirements
• Residual empty capsid
• Residual host cell DNA
• How these purification requirements
differ between gene therapy and
gene-modified cell therapy

10:30 Coffee Break

10:45 Session 8:
Purification Techniques
Discuss what techniques to use at what stage of
production and why they should be used. Also
discuss what can be seen and what cannot be
seen and how this can affect the overall design
of a therapy. Discuss the different ways to titre
viruses and how this can be relating to the specific
characteristics of the virus itself. Discuss inducible
as well as SIV approach and the issues related to
each methodology.
• ELISA
• q PCR
• HPLC
• TCID50
• Replication competent
lentivirus detection
• QC of cell therapeutic products

12:15 Coffee Break

12:30 Session 9:
Group Exercise Session
In groups, delegates will consolidate the previous
talks and brainstorm the purification requirements
and techniques they need to use for their particular
viral vector or gene therapy methodology rolling
on from the previous group sessions.

13:30 Feedback/Evaluation session

13:40 END End of Day3

All dates and times are expressed in UTC/GMT+2

on the Agenda (CET Time Zone)

www.glceurope.com booking@glceurope.com +36 11 848 05 96

848 0515
Cell & Gene Therapy MasterClass 16-18 October, 2023
- with focus on viral vectors
Online MasterClass
- EU edition

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Cell & Gene Therapy EU MasterClass - with focus on viral vectors
16-18 October, 2023, Online MasterClas

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Attendance Fee - € 1198 / 3 delegates* Solution Provider Fee - € 1198 / delegate

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