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As more stem cell discoveries are translated, the development of products based on these discoveries will depend on solving manufacturing challenges, including the scale-up or scale-out of products to achieve commercial quantities and qualities. This four-part meeting series is aimed at addressing these manufacturing and regulatory challenges to bring promising new cell therapies to the clinic.

Co-Organizers

Jacqueline Barry Square

Jacqueline Barry, PhD
Catapult Cell and Gene Therapy, UK

Melissa Carpenter Square

Melissa Carpenter, PhD
ElevateBio, USA

Program

Characterization of Starting Material
10 May 2021
08:00 - 09:30 EDT (view your time zone)
Innovation Showcase: ElevateBio

Hursh_square
Deborah Hursh, PhD
CBER, US FDA, USA
Nissim Benvenisty_square
Nissim Benvenisty, PhD
The Hebrew University of Jerusalem, Israel
Yoji SATO_square
Yoji Sato, PhD
NIHS, Japan
Tenneille Ludwig_square
Tenneille Ludwig, PhD
WiCell, USA

The Development of Hypo-Immunogenic Pluripotent Stem Cells
17 May 2021
08:00 - 09:30 EDT (view your time zone)

Developing pluripotent-based cell therapies that can evade the host immune system is key to “off the shelf” allogeneic approaches. This program will highlight several approaches in making and testing genetically-modified, hypo-immune cells and the regulatory considerations around their clinical/commercial use.

Anna_Kwilas_Square
Anna Kwilas, PhD
US FDA, USA
Andras Nagy_square
Andras Nagy, PhD
PanCella, Canada
Akitsu Hotta_square
Akitsu Hotta, PhD
CiRA, Japan
Sonja_Schrepfer_Square
Sonja Schrepfer, MD, PhD
UCSF and Sana Biotechnology Inc., USA

Scale-up Manufacturing of Pluripotent Stem Cell Products
24 May 2021
12:00 - 13:30 EDT (view your time zone)
Innovation Showcase: Catalent Cell & Gene Therapies

As more stem cell discoveries are translated, the successful commercialization of these therapies will depend on solving multiple challenges, including one of the most significant - scaling-up. What does it take to develop a process that is scalable to produce large, consistent batches of cells? Hear from experts in this space leading the way in the scale-up of pluripotent stem cell products for therapeutic purposes.

Marina Goldfeld_square
Marina Goldfeld, MA
BlueRock Therapeutics, USA
Moria Francois_square
Moira Francois, PhD
CGT Catapult, UK
Stefan_Braam_Square
Stefan Braam, PhD
NCarida, Belgium
Harsha Gupta
Harsha Gupta
Cynata Therapeutics, Ltd, Australia

Navigating the Regulatory Environment: International Regulations for Pluripotent Derived Products
1 June 2021
10:00 - 11:30 EDT (view your time zone)
Innovation Showcase: Ajinomoto and Cedars-Sinai Biomanufacturing Center

The manufacturing and commercialization of a cellular therapy has numerous challenges, including navigating the complex international jurisdictions and regulations of such products. While efforts to harmonize many of these standards are underway, the current regulatory landscape varies by country and jurisdiction so advance understanding of the relevant standards and regulations is important if one wants to develop a product that is marketed in different regions of the world. In this program you will hear from experts who have gone through this process from the development and regulatory perspectives.

Jacqueline Barry Square
Jacqueline Barry, PhD
Catapult Cell and Gene Therapy, UK
Fumihito Takanashi_Square
Fumihito Takanashi
Ministry of Health, Labour and Welfare, Japan
Pete Coffey, PhD
UC Santa Barbara, USA and UCL, UK

Sponsors

Catalent 400x200

Gold Sponsor

Lonza_400x200

Gold Sponsor


Ajinomoto 400x200

Silver Sponsor

CedarsSinai_400x200

Silver Sponsor

ElevateBio_400x200

Silver Sponsor


BioLamina400x200

Bronze Sponsor

Pluristyx_400x200

Bronze Sponsor

STEMCELL Technologies 400x200

Bronze Sponsor