Join us April 20-23, 2020 for Global Cell & Gene Digital Week, a global 4-day series of live educational webcasts and downloadable resources providing the latest insights for ground breaking gene editing technology, cell therapy, Gene Edited Ex Vivo Cell Therapy, and gene therapy. To learn about sponsorship of future events, contact contact partners@knect365lifesciences.com.

Day 1 - Monday, April 20, 2020



Meeting Regulatory Requirements for Cell and Gene Therapy Manufacturing
9am EST / 2pm GMT / 3pm CET

Session Description TBD

Speakers:

Karen Magers
Head of Regualtory Affairs, Cell and Gene Technologies
Lonza Pharma & Biotech

Rajesh Thangapazham
Head of Regualtory Strategy, Cell and Gene Technologies
Cell and Gene Technologies Lonza Pharma & Biotech

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Off-The Shelf, TCR-transduced Gamma Delta T Cells for Solid Cancers
10am EST / 3pm GMT / 4pm CET

Session Description TBD

Speaker:

Ali Mohamed
VP, CPC
Immatics

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Rational Process Development and Analyticals Impacting Cell and Gene Therapies Manufacturing
11am EST / 4pm GMT / 5pm CET

Session Description TBD

Speaker:

Manuel J. T. Carrondo, PhD
Vice President
iBET, Portugal

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Day 2 - Tuesday, April 21, 2020



Improved T Cell Function Through Metabolic Modulation Towards an Early-Memory Status
9am EST / 2pm GMT / 3pm CET

Chimeric antigen receptor (CAR) -T cell therapy is a promising immunotherapy due to the ability to rapidly deliver a population of tumor specific T cells. Despite the impressive response rates in patients treated with FDA approved CAR-T cells, not all patients respond to CAR-T therapy. Studies have shown a correlation between central memory T cells and clinical response, whereas T cells from non-responders upregulate genes associated with effector differentiation, glycolysis, and apoptosis.

Therefore, elucidating the metabolic requirements that shift T cells toward higher efficacy will allow us to formulate T cell media that foster the production of therapies capable of converting non-responders into responders. One potential strategy to bolster in vivo persistence and efficacy is to “re-program” T cells during ex vivo manufacturing. Tools that will allow us to execute this strategy include our advanced metabolic and proteomic capabilities, a robust T cell expansion medium, and a deep understanding of how the workflow affects the cellular product. We have applied this approach in the development of a new T cell expansion medium that retains a more favorable phenotype, while increasing T cell growth. By combining optimally engineered cells and a “smarter” T cell medium with a fine-tuned workflow, we aim to improve T cell function, even in T cells from patients previously categorized as non-responders.

Speaker:

Evan Zynda
Research and Development, Bioproduction
Thermo Fisher Scientific

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Optimization of T Cell Expansion Under Stirred Conditions in ambr15 ® Microbioreactors Using a DoE Approach and Process Transfer to Larger Scale, Benchtop Bioreactors
10am EST / 3pm GMT / 4pm CET

For many therapeutic cellular products, the development of a scalable cell expansion process optimized for quality and costs is a crucial step in their manufacturing process. In this case study, we optimized T cell expansion under stirred conditions using the automated, micro-scale ambr® 15 platform. In a first step, parallel experiments testing performance of various T cell media in the ambr® 15 microbioreactors and static well plates or T flasks revealed differences in media performance under agitated and static conditions. Performing a DoE approach using the MODDE software, further process parameters (pH, DO, stirring speed, Il-2 concentration, seeding density) were optimized. Based on optimal parameter settings determined in the ambr® 15 DoE studies, we successfully transferred agitated T cell expansion from ambr® 15 microbioreactors to larger scale, ambr® 250 modular bioreactors.

Participants of this webcast will learn how high-throughput tools such as the ambr® 15 system can be used as an early stage process optimization platform to define process parameter settings in a time- and cost-efficient manner. Furthermore, participants will gain knowledge about the benefits of DoE studies in process development and for further process transfer to larger scale bioreactors.

Speaker:

Dr. Julia Hupfeld
Scientist Regenerative Medicine PD
Sartorius Stedim Biotech

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A look at Fujifilm Diosynth Development of an Advanced Gene Therapy Platform
11am EST / 4pm GMT / 5pm CET

The success of gene therapies has increased the number of companies that are entering this arena and seeking advice on how they should produce their product candidates. FUJIFILM is developing a platform for AAV production.

Our platform will contain

  1. A suspension HEK293 cell line
  2. GMP grade Adenovirus helper
  3. GMP rep/cap plasmid representing several AAV serotypes
  4. A GOI plasmid for insertion of genes and
  5. Tools for in-process and release testing.

Speaker:

Steve Pincus, PhD
Head of Science and Innovation
FUJIFILM Diosynth Biotechnologies

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Day 4 - Thursday, April 23, 2020



Serendipity: To Find a Process While Looking for a Product
9am EST / 2pm GMT / 3pm CET

The talk will give an overview of opportunities and challenges related to the Cell and Gene Medicinal product, main focus will be the manufacturing side of advance therapies including but not limited to:

  • Sustainability and Manufacturability of Cell and Gene therapy product
  • The critical impact of raw materials and related bottlenecks
  • Challenges and opportunities for logistics and analytics
  • Opportunity of “contaminations” from other industries

Speaker:

Stefano Baila
Director of Operations
Anemocyte

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Understanding the Critical Roles of cGMP Chemicals and Single-Use Technologies in Cell & Gene Therapy Manufacturing
10am EST / 3pm GMT / 4pm CET

Rapid developments in cell & gene therapy have resulted in recent product approvals, bringing these transformative medicines to market to improve global health and well-being. Commercializing these products, however, have introduced a unique new set of challenges incl. consistent quality, continuity of supply, reducing contamination risks and open processing.

Learn how Avantor is enabling our customers scale therapies from R&D to patient delivery, faster and safer. Our experts will discuss why using cGMP chemicals matters in these applications, how to improve product sampling, and other developments in this innovative area in 2020.

Speakers:

Timothy Korwan
Director, New Product Developments
Avantor, Inc

Wayne Lynch
Product Manager
Avantor, Inc

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Comparison of qPCR and ddPCR for Analysis of Residual DNA and AAV Quantification
11am EST / 4pm GMT / 5pm CET

Session Description TBD

Speakers:

Sumaya Dauleh
Senior Analyst
Intertek Pharmaceutical Services

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