MONT-SAINT-GUIBERT, Belgium — Cellistic®, a pioneer in iPSC-based off-the-shelf cell therapy development and manufacturing, announces the successful audit and GMP certification of its first-of-its kind facility dedicated to manufacturing therapies based on induced pluripotent stem cells (iPSCs). This achievement signifies Cellistic’s quality and regulatory readiness, which is now certified by the Belgian Federal Agency for Medicines and Health Products (FAMHP), operating under European Medicines Agency (EMA) guidelines. [Read more…]
9 Reasons Cell Therapy is the Future of Human Health
Cell therapy is the use of cells and tissues to regenerate, repair, and in some instances, even enhance human health. Traditionally, the modern medical system has relied on a pharmaceutical-based approach. This led to the rise of the U.S. Food and Drug Administration (FDA) which was founded in 1906, making it 111 years old this year. Unfortunately, our approach to human health has not experienced a dramatic shift over the past 100+ years, and as a society, we still tend to rely on a drug-based approach.
Below, we profile eight strengths of cell therapy that will propel cell therapies to the forefront of mainstream medicine.
In this article:
Best Practices in MSC Culture: Tracking and Reporting Cellular Age Using Population Doubling Level (PDL)
Author: Jon Rowley, RoosterBio
This is a guest post from RoosterBio. RoosterBio is an innovative company that provides standardized stem cell product platforms to enable rapid clinical and commercial translation.
There has been much discussion in the literature and the blogosphere (here, here, and here) lately about keeping track of cellular age, and there is very good reason for this. First, there are multiple regulatory guidelines that propose tracking the age of cells used in biologics manufacturing. Secondly, it is well documented that cell phenotype and function can be compromised the older a cell is. A few examples from the literature as this relates to human Mesenchymal Stem Cells (hMSCs) are: [Read more…]
Are Cell Therapy Companies Prioritizing Autologous Or Allogeneic Therapies?
This article highlights ten leading cell therapy companies, all of which have promising cell therapy products being evaluated in clinical trials. These 10 companies were chosen because they are market leaders with robust financial funding, novel technologies, and strong therapeutic pipelines. [Read more…]
Leading iPSC Mass Production Equipment Manufacturers
Induced pluripotent stem cells (iPSCs) represent a groundbreaking advancement in biotechnology. iPSCs are a type of pluripotent stem cell generated by reprogramming adult somatic cells to an embryonic-like state, allowing them to differentiate into virtually any cell type in the body. This innovative technology provides a powerful tool for regenerative medicine, disease modeling, and drug discovery by offering a patient-specific source of cells for research and therapeutic applications. [Read more…]
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