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07:40 - 08:40

Registration

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08:40 - 08:45
Chairperson’s Opening remarks

Chairperson’s Opening remarks

  • Miguel Forte - CEO, Zelluna, Norway
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Showing of Streams
10:45 - 11:15

Morning Coffee and Networking

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Showing of Streams
12:55 - 14:10

Lunch, Networking and Live Labs

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Showing of Streams
15:50 - 16:20

Afternoon Coffee

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Showing of Streams
17:30 - 17:40

Chairperson’s Closing Remarks

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17:40 - 18:00
Info

Rapid Quantification of Adeno-Associated Virus and Lentivirus Vectors

Viral vectors such as adeno-associated virus (AAV) and lentivirus are currently in use for gene and cell therapies.  Rapid and accurate enumeration of these viral particles is critical for the safety and efficacy of these promising new therapies.  However, obtaining this information can be a challenge as current techniques are slow and imprecise.   ELISA tests are subjective and the variability depends on the operator.  qPCR takes hours and ultimately only delivers a genome count.  While vector genomes/mL is required for dosing, further characterization of the vector formulations is required for patient safety.  Furthermore, the amount of time involved in these methods makes them challenging for use in in-process monitoring of vector growth and formulation.  The Virus Counter 3100® platform using antibody-based ViroTag® reagents from Sartorius Virus Analytics offers a rapid and precise solution to these problems. 

Here, we show how the new ViroTag AAV8-9 and ViroTag VSV-G can be used to quantify crude and purified AAV-8, AAV-9, and VSV-G pseudo-typed lentivirus vectors.  Using a patented no-wash assay and the Virus Counter 3100 platform, biologically relevant total particle counts can be obtained in three minutes following a 30 minute incubation.   The speed and precision of this technique makes it practical for in-process monitoring as well as characterization of a final formulation.

  • Rebecca Montange - Scientist, Sartorius Stedim North America, Inc, USA
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18:00 - 18:30

Closing Plenary Session – TITLE TBC

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18:30 - 18:35
Networking Drinks and Evening Social Event

Networking Drinks and Evening Social Event

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07:40 - 08:40 60 mins
Registration
08:40 - 08:45 5 mins
Chairperson’s Opening remarks
  • Miguel Forte - CEO, Zelluna, Norway
08:45 - 09:05 20 mins
Info
Joint Plenary Session
Innovative solutions from Industry 4.0
  • Michael May - Chief Executive Officer, Centre For Commercialization Of Regenerative Medicine
  • Potential to providing real-time visibility 
  • Control across complex cell and gene therapy supply chains 
  • QbD
  • How can industry 4.0 drive the industry towards increased industrialization?
09:05 - 09:25 20 mins
Info
Joint Plenary Session
Designing production facilities of the future
  • Geoffrey Hodge - Operations Senior Vice President, Unum Therapeutics, USA
  • Case study
  • How can facilities be produced to meet the potential demand of cell and viral vectors
  • What needs to change and what innovations are being made
09:25 - 09:45 20 mins
Info
Joint Plenary Session
Patient specific therapies and the need for a paradigm shift
  • Ohad Karnieli - Chief Executive Officer, Atvio, Israel
  • How innovation could lead to a more flexible process based on having enhanced product and process understanding
  • How would this then be adaptable to manage critical sources of variability
  • Potential for Analytical Technologies (PAT) comprised of sensors with multivariate data analytics and control algorithms as well as electronic data records and enterprise systems to enable efficient knowledge sharing across components in the supply chain
09:45 - 10:05 20 mins
Joint Plenary Session
Spotlight presentation
  • A Representative from GE Healthcare, GE Healthcare
10:05 - 10:20 15 mins
Joint Plenary Session
Spotlight presentation
  • A Representative from Lonza, Lonza, Switzerland
10:20 - 10:45 25 mins
Info
Joint Plenary Session
Discussion Panel: What do industry need to innovate the cell and viral vector industries?
  • Ohad Karnieli - Chief Executive Officer, Atvio, Israel
  • Michael May - Chief Executive Officer, Centre For Commercialization Of Regenerative Medicine
  • Geoffrey Hodge - Operations Senior Vice President, Unum Therapeutics, USA
  • Stewart Craig - CMO, Orchard Therapeutics, USA
  • What innovations do industry need to make it possible to treat 100’s of patients? 
  • What can vendors do to innovate platforms they currently provide?
  • Where do the gap’s lie?
  • What is can be done to prevent demand outgrowing capacity?
10:45 - 11:15 30 mins
Morning Coffee and Networking
11:15 - 11:50 35 mins
Info
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Analytical method establishment and qualification
  • What type of qualification activities are appropriate
  • What will this look like when the method is validated further along in the process?
  • Specific case studies
11:15 - 11:50 35 mins
Info
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
A forward look at the future of cell therapy manufacturing
  • Jon Gunther, PhD - Associate Director, Juno Therapeutics Inc, USA
  • What does the future of manufacturing look like?
  • Review of different technologies out there
  • Where do the gaps lie?
11:15 - 11:50 35 mins
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Zelluna Immunotherapy Case Study
  • Arjan Roozen - CTO, Zelluna, Norway
11:50 - 12:25 35 mins
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Case study: Equivalence testing for a multi-plate potency assay of viral vector
  • Sara Paulo - Analytical Specialist, FinVector Oy, Finland
11:50 - 12:25 35 mins
Info
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Implementation of an affordable and scalable manufacturing strategy
  • Bas Leewis - MSAT Manager, MeriaGTx, UK
  • Case study
11:50 - 12:25 35 mins
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Gamma-Delta T Cell Case Study
  • Michael Leek - CEO, TC BioPharm, UK
12:25 - 12:55 30 mins
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Spotlight presentation
  • A Representative from Miltenyi Biotec, Miltenyi Biotec, Germany
12:25 - 12:55 30 mins
Info
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Viral Safety in Viral Therapeutics
  • Rolf Werner - Professor, Labor Dr. Merk & Kollegen, Germany
  • No pH inactivation
  • No viral removal by nano filtration
  • Preventive measures in MCB/WCB and MVB/WVB
  • No animal derived raw materials
  • Suspension cell culture processes
  • Affinity chromatography for viral therapeutics
  • Sterile filtration of media and buffer
  • Sanitization of resins and membranes
12:25 - 12:55 30 mins
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Spotlight presentation
  • A Representative from Fujifilm, Fujifilm
12:55 - 14:10 75 mins
Lunch, Networking and Live Labs
14:10 - 15:20 70 mins
Info
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Dual Dialogue: Combination of analytical methods for characterization of viral vectors
  • Jessica Alsiö - Regulatory CMC Manager, Novartis Animal Health Inc
  • Katy Barglow - Director, Process Sciences and Analytical Development, 4D Molecular Therapeutics, USA
  • Analytical methods used in development and production of vectors for gene therapy
  • Quantification with molecular methods
  • Need for standards in analytical methods for vectors
14:10 - 14:45 35 mins
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Case study: Use of stir tank bioreactor and BEVS technology to produce at 500L scale
  • Juan Pablo Labbrozzi - Lead Scientist, UniQure Biopharma BV, Netherlands
14:10 - 14:45 35 mins
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Celyad Case Study
  • Sophie Agaugue - R&D Manager, Celyad, France
14:45 - 15:20 35 mins
Info
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Panel discussion: What can cell therapy manufacturers learn from MAbs to save time and money on the path to commercial scale manufacturing
  • Moderator Christopher Bravery - Director, Training Courses Department, Consulting On Advanced Biologicals Ltd
  • Panellist Karin Hoogendoorn - Scientist ATMP Product Development, Leiden University Medical Centre (LUMC), The Netherlands
  • Panelist Greg Stromberg - Associate Director, Global Manufacturing Sciences, Biogen, USA
  • Panelist Houssam Alosta - Senior Manager, Bioprocess Engineering, BlueRock Therapeutics, Canada


  • Where current gaps lie in cell therapy manufacturing – do MAb manufacturers have advice on how to fill these
  • What technologies and process improvements can the cell therapy industry take away from their counterparts
  • Feedback and discussion on how to improve current processes
14:45 - 15:20 35 mins
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Case study: ART-I02, a gene therapy vector for arthritis
  • Janneke Meulenberg - COO, Arthrogen, Netherlands
15:20 - 15:40 20 mins
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Spotlight presentation
  • A Representative from Pall, Pall, USA
15:20 - 15:40 20 mins
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Agility by Design: a new strategy to address the cell & gene therapy manufacturing challenges
  • Romain de Rauville - Business Development Manager, MaSTherCell, Belgium
15:20 - 15:35 15 mins
Info
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Spotlight presentation

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

• Use an exhibition stand to meet new clients in the main networking area

• Raise your corporate profile and shape your corporate image with logo placement

• Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Michael Dunnet, Tel:  +44 (0)20 7017 7870; Email: michael.dunnet@knect365.com

15:35 - 15:50 15 mins
Info
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Spotlight presentation

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

• Use an exhibition stand to meet new clients in the main networking area

• Raise your corporate profile and shape your corporate image with logo placement

• Ensure market presence as a thought leader with a speaking position


For sponsorship and exhibition opportunities please contact: Michael Dunnet, Tel:  +44 (0)20 7017 7870; Email: michael.dunnet@knect365.com

15:40 - 15:50 10 mins
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Spotlight presentation
  • A Representative from Cell Genix, Cell Genix, Germany
15:40 - 15:50 10 mins
Info
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
A presentation from Anemocyte
  • Stefano Baila - Director of Operations & Business Development, Anemocyte, Italy
15:50 - 16:20 30 mins
Afternoon Coffee
16:20 - 16:55 35 mins
Info
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Principles, implications and benefits of applying QbD to analytics
  • Margit Jeschke - Global Head, Analytical Stewardship and CMC Correlation, Novartis, Switzerland
  • Characterising the product

    Case study tisagenlecleucel, a CAR T cell product

16:20 - 17:30 70 mins
Info
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Dual Dialogue: When to make the decision to either insource or outsource
  • Lior Raviv - Director, Development Department, Pluristem Ltd, Israel
  • Greg Stromberg - Associate Director, Global Manufacturing Sciences, Biogen, USA

Dual Dialogue: When to make the decision to either insource or outsource

  • When is the best time to make the decision on in sourcing vs. outsourcing?
  • What are the limitations of building your capabilities in house?
  • What are the benefits vs. the costs?
  • Pros and cons of both models
  • What is better for large vs. small companies?
  • What sort of bioprocess equipment makes sense for CMO’s opposed to therapeutic companies?
  •  Enterprise solutions vs. ability to customise
16:20 - 16:55 35 mins
Info
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Transforming cell therapy with gene editing: the case of “off-the-shelf” engineered CAR-T in the clinic
  • David Sourdive - Corporate Development Executive Vice President, Cellectis

Gene-editing has enabled off-the-shelf allogeneic CAR-T product candidates to reach the clinic. It is also endowing engineered cells with multiple new features, enhancing their capabilities and functions to better address cancer. Hindsight in industrializing 3 different such gene-edited immuno-oncology products now in active trials, and the human clinical experience with the first cases in ongoing studies signal practical avenues for their further deployment and shed light on the transformative role they will play in the anti-cancer arsenal.

16:55 - 17:30 35 mins
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Discovery of Novel TcRs for Cancer Therapy
  • Andy Hurwitz - Vice President, AgenTus Therapeutics Inc., USA
17:30 - 17:40 10 mins
Chairperson’s Closing Remarks
17:40 - 18:00 20 mins
Info
Rapid Quantification of Adeno-Associated Virus and Lentivirus Vectors
  • Rebecca Montange - Scientist, Sartorius Stedim North America, Inc, USA

Viral vectors such as adeno-associated virus (AAV) and lentivirus are currently in use for gene and cell therapies.  Rapid and accurate enumeration of these viral particles is critical for the safety and efficacy of these promising new therapies.  However, obtaining this information can be a challenge as current techniques are slow and imprecise.   ELISA tests are subjective and the variability depends on the operator.  qPCR takes hours and ultimately only delivers a genome count.  While vector genomes/mL is required for dosing, further characterization of the vector formulations is required for patient safety.  Furthermore, the amount of time involved in these methods makes them challenging for use in in-process monitoring of vector growth and formulation.  The Virus Counter 3100® platform using antibody-based ViroTag® reagents from Sartorius Virus Analytics offers a rapid and precise solution to these problems. 

Here, we show how the new ViroTag AAV8-9 and ViroTag VSV-G can be used to quantify crude and purified AAV-8, AAV-9, and VSV-G pseudo-typed lentivirus vectors.  Using a patented no-wash assay and the Virus Counter 3100 platform, biologically relevant total particle counts can be obtained in three minutes following a 30 minute incubation.   The speed and precision of this technique makes it practical for in-process monitoring as well as characterization of a final formulation.

18:00 - 18:30 30 mins
Closing Plenary Session – TITLE TBC
18:30 - 18:35 5 mins
Networking Drinks and Evening Social Event