Bridging the Gap: Streamlining iPSC-Derived Cell Line Development from Donor Cells to MCB
Allogeneic iPSC-derived therapies hold immense promise, offering scalable, off-the-shelf solutions for a wide spectrum of diseases. However, the journey from donor cells to a gene edited, clinically compliant GMP Master Cell Bank (MCB) is fraught with challenges and is particularly vulnerable to risks stemming from misaligned early development.
A major bottleneck seen in the majority of iPSC therapeutic programs arises when development teams continue to rely on R&D grade cell lines to confirm proof-of-concept, conduct preclinical animal studies, and to start process & analytical development. [Read more…]
What is CAR-T Cell Therapy? A New Way to Treat Cancer
CAR-T cell therapy is as a type of immunotherapy that teaches T cells to recognize and destroy cancer. CAR-T cell therapy has demonstrated promising results in a range of patients across the globe. In some patients, this can lead to the total elimination of the cancer. In others, there is a significant improvement of the disease.
For those confronting cancer, one crucial question often arises: What is CAR-T cell therapy? This guide answers the most common questions and explains how this innovative technology is transforming the future of cancer treatment.
What is the Definition of Regenerative Medicine (RM)?
As with any rapidly evolving field, defining the scope and boundaries of regenerative medicine is a challenge. However, understanding this innovative industry requires examining the foundational components of the human body and the groundbreaking technologies designed to restore or enhance its function. To understand the definition of this scientific field, it is critical to understand the key components that compose the human body, which are: [Read more…]
List of U.S. FDA Approved Cell and Gene Therapy Products (46)
Today, researchers and clinicians are under great pressure to develop therapies capable of reversing or significantly impacting the progression of disease. In recent years, the arrival of the cell and gene therapy industries have introduced the possibility of providing transformative, durable and potentially curative outcomes for a diverse range of life-threatening conditions, as well as injuries, degenerative diseases, genetic disorders, and cancers. [Read more…]
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