Tag: GMP Bone Marrow

Navigating the complex world of regulations: How AllCells is changing cell therapy and protecting against product-ending events

The cell therapy market is valued at 15 billion dollars and is set to double in value by 2030. Cell therapy has been instrumental in the development of treatments like CAR-T therapy, which uses the body’s own T cells to fight cancer. The opportunity within cell therapy is significant, targeting common diseases that afflict millions […]

Written by on February 23, 2023

The Key to Developing Good Manufacturing Practice (GMP) Biomaterials for Cell and Gene Therapy Development

A decade ago, the emergence of new immunotherapies in the cell and gene therapy (CGT) space opened up new avenues to treat disease, sparking excitement across the industry. However, the path to commercialization has been a steep learning curve for both companies and regulatory agencies given the uncharted waters of these new modalities. Now that […]

Written by on October 3, 2022

The Therapeutic Potential of HSC-based Gene Therapies

Hematopoietic stem cells (HSCs) have immense therapeutic potential because of their ability for both self-renewal and multi-lineage differentiation to maintain hematopoietic homeostasis. This rare population of cells are characterized by the presence of the cell surface marker CD34, which is useful for their identification and isolation from the bone marrow and peripheral blood. In the […]

Written by on July 25, 2022

Why You Should Start Clinical Grade Cell Supply Discussions Early in Cell and Gene Therapy Development

Cell and gene therapies represent an expanding category of transformative medicines with the potential to change the way we treat human diseases. Broadly, these novel therapies include both in vivo and ex vivo strategies to modify target cells. Ex vivo therapies that involve isolating cells from a patient (autologous) or a donor (allogeneic) and modifying […]

Written by on May 24, 2022

What You Need to Know About Regenerative Medicine in 2022: Industry and Tech Trends

Growth in the Regenerative Medicine Field The regenerative medicine sector is on track for another watershed year where clinical progress, continued growth, and segmentation into new disease areas affecting larger patient populations is anticipated. With over 2,600 active clinical trials in 2021, the clinical pipeline is maturing at a rapid pace. Forty three percent of […]

Written by on April 20, 2022

A Donor-Centric Approach to Cell and Gene Therapy

In the past decade, emerging therapeutic modalities like cell and gene therapies have opened up new treatment options for previously intractable diseases, changing the industry needs for primary tissues. While autologous therapies—which are created using a patient’s own cells—still dominate the field, many cell and gene developers are investing in allogeneic therapies that can be […]

Written by on February 3, 2022

AllCells Announces New GMP Cleanroom

Expansion of GMP capabilities to support the rapidly growing cell and gene therapy industry AllCells Alameda, CA Expands GMP Processing Capabilities AllCells, the industry leader in the procurement and customization of human-derived hematological tissues and services, is pleased to announce the expansion of its flagship processing facility in Alameda, California. The expansion includes the addition […]

Written by on December 13, 2021

FAQ Series: Comparison of CD34+ Cells from Different Tissue Sources

Welcome to the second installment of our FAQ blog series! Today, we are looking at differences between CD34+ cells isolated from different tissue sources to provide a better understanding of this important cell population. Hematopoietic stem cells (HSCs) are an important and rare population of cells that reside in a specialized niche within the bone […]

Written by on July 16, 2021

Clinical Applications of Bone Marrow-Derived Mesenchymal Stem Cells

While next generation cell-based treatments like CAR-T immunotherapies have been the source of much excitement and clinical investment in recent years, cellular therapies have a long, established history in the clinic.  Bone marrow (BM) or hematopoietic stem cell transplantation has been the standard of care to treat a variety of blood and immune system diseases […]

Written by on June 17, 2021

Good Manufacturing Practices (GMP) Facilitates Good Products

With the FDA approvals of several cell therapy products (Kymriah® and Yescarta®) and many more cell therapies progressing towards clinical trials, sourcing high-quality cellular materials has become a critical determinant of cell therapy development success. Particularly as allogeneic approaches to cell therapies become more feasible, access to donor cells that meet regulatory, quality, and quantity […]

Written by on May 7, 2021