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Why is Healthy Donor Tissue So Important for Cell and Gene Therapies?

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Brad Taylor, PhD and Dominic Clarke, PhD
HemaCare Corporation 8500 Balboa Boulevard Suite 130 Northridge CA 91325

INTRODUCTION

Public discourse on cell and gene therapy is focused on novel approaches to long-established procedures such as bone marrow transplants, as well as on truly innovative treatments such as cancer immunotherapy and stem cell therapy for autoimmune disorders and other serious ailments. Positive clinical trial results and the demonstrated success of advanced therapies such as Kymriah® and Yescarta® are fueling a sense of excitement on what could be accomplished with these medicines—and driving a significant increase in the number of cell therapies in the clinical trial pipeline. As of last year, there were nearly 300 different cell and gene therapies in development, and that number is on target to grow.[1] [Read more…]

New Frontiers in Gene-Editing and Stem Cell Innovation – Interview with Dr. Chen-Tsai of Applied StemCell

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Applied StemCellI had the honor of interviewing Dr. Ruby Yanru Chen-Tsai, Chief Scientific Officer and Co-founder of Applied StemCell Inc. (ASC), a fast growing biotechnology company in Milpitas, California. Specializing in gene-editing technologies and stem cell innovation, ASC offers an optimized series of tools for basic research study, drug discovery, bio-processing, bio-production and preclinical applications.

In this fascinating interview, we discuss Dr. Yanru Chen-Tsai’s impressive background, ASC’s unique product portfolio, its TARGATT™ gene editing technology, and the company’s future trajectory. [Read more…]

Cellectis Secures 82,000 Sq Ft Manufacturing Facility in Raleigh to Compliment Paris Facility

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CellectisCellectis, a leading French biopharmaceutic company, has signed a lease agreement for an 82,000 sq. ft. manufacturing facility in Raleigh, North Carolina, to complement its existing 14,000 sq. ft. manufacturing facility in Paris, France.

Located at 2500 – 2540 Sumner Boulevard in Raleigh, NC, the new USA facility is owned by Equus Capital Partners and will be used for clinical and commercial production of Cellectis’ leading allogeneic UCART products.

Importantly, the decision will combine the capabilities of Cellectis’ two facilities to advance its manufacturing processes and prepare for potential commercialization of its UCART products in the future. [Read more…]

Australian TGA Approves Novartis’ Kymriah® CAR-T Therapy for Two Blood Cancers

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Kymriah® (tisagenlecleucel), CAR-T therapy from Novartis, receives TGA approval for treating two aggressive blood cancers

  • Kymriah® is an immunocellular therapy that is a one-time treatment manufactured individually for each patient using the patient’s own T cells, genetically reengineered and programmed to recognise and destroy cancer cells.
  • Kymriah® is approved for the treatment of relapsed or refractory patients with paediatric B-cell acute lymphoblastic leukaemia (ALL) and adult diffuse large B-cell lymphoma (DLBCL)[1]
  • Kymriah® could be a treatment option for about 50 paediatric and young adult ALL patients and 420 adult DLBCL patients who relapse or do not respond to initial therapy[2]
  • Kymriah® is the only chimeric antigen receptor T cell (CAR-T) therapy to receive TGA approval in Australia[1]

[Read more…]

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