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Our #philadelphia site has been approved by the U.S. #FDA to begin the analytical testing and manufacturing of #Amtagvi for Iovance Biotherapeutics, Inc., which received an accelerated approval of its Biologics License Application (#BLA) on February 16, 2024.  Congratulations to Iovance Biotherapeutics, Inc. on this major milestone! With this announcement, our site at the Navy Yard in Philadelphia becomes the first U.S. external manufacturing site and the first third-party #CTDMO to be approved to support the commercial manufacturing and release of an individualized T cell therapy for a solid tumor cancer.  We are thrilled to help through each step of the drug development pipeline – from research to clinical manufacturing to approval and we are proud to partner with healthcare innovators to advance medical discoveries and deliver groundbreaking treatments to patients globally.   https://lnkd.in/duTPi9TA   #celltherapy #tcells

WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance’s AMTAGVI™ (lifileucel) for Advanced Melanoma

WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance’s AMTAGVI™ (lifileucel) for Advanced Melanoma

https://advancedtherapies.com

George Coukos

Director of Oncology University Hospital of Lausanne & Branch Director at Ludwig Cancer Research

5mo

A tangible example of how the investments by the University of Pennsylvania in their CAR T program made Philadelphia an international hub for Cell & Gene Therapy biotech and Medtech 15 years later. Congrats!

Shawn Branning

Business Line Owner, Commercial Accelerator, and Global Strategist for Public and Private Equity Businesses | MBA

5mo

Congratulations on this latest milestone. It is also great to see further growth coming to the Philadelphia area biologics industry.

Nagesh Ramesh, Ph.D.

President @ Life Plasma | Leading Plasma Innovations

5mo

What a great story for patients. Congratulations to Iovance Biotherapeutics, Inc., WuXi Advanced Therapies and FDA!! Great to see Philly area advancing in Life Sciences.

Syed Rafat Husain, Ph.D.

Executive Director, CMC Regulatory Affairs

5mo

Thanks for supporting Iovance innovative TIL therapy manufacturing and testing, and approval.

Maria Relles, BSN, MD

Site Manager: Aseptic Management and Compliance/ Family Medicine

4mo

To my good friends in WuXi and Iovance Congats! Finally Lifileucel program is getting the support it needs to move forward in melanoma management. Kudos!

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Ruben Dario Taborda

Broad based Healthcare Executive - CEO Quality Management | Supply Chain | Process Efficiency | Talent Development | Customer Success | Digital/SAAS | Supplier Diversity | Board of Director | Community Engagement

4mo

Congratulations to Wuxi on achieving this milestone. AVS Life sciences (via MWA consulting) is proud to be a partner of Iovance Biotherapeutics.

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Alejandra Gurevich, Ph. D.

CAR-T Manufacturing Team Lead

5mo

Congratulations taking cell therapy to the next level!!!

Declan Ryan

Vice President Business Development at WuXi AppTec

5mo

Congrats

Karen Doucette

Scientific Advisor, CGT

5mo

Congrats ATU! Glad to see this cross the finish line.

Dirk Groenewegen

Cell & Gene Therapy New Business Coach

5mo

Serious production, for a serious therapy , congratulations!

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