Tag: GMP

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

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

GMP Leukopaks for Allogeneic Cell Therapies

Adoptive cell therapies (ACTs), which is a treatment based on transferring cells (most often immune cells) into a patient, have revolutionized the standard of care to treat a broad range of diseases. It has perhaps made the most impact in cancer immunotherapy where the successes of chimeric antigen receptor (CAR) T cell therapies to treat […]

Written by on December 13, 2021

GMP Leukopaks Mitigate Risk in Cell and Gene Therapy Workflows

Isolated human primary cells are able to retain the morphological and functional characteristics of their tissue of origin, which makes them invaluable tools in life sciences to advance our understanding of cellular biology and molecular mechanisms that are aiding researchers in the development of novel therapeutic approaches to treat human diseases. For instance, primary lymphocytes […]

Written by on December 13, 2021

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