Cell Therapies

Manufacturing Pluripotent Cell Therapeutics

Here we review strategies for gaining Food and Drug Administration (FDA) approval of allogeneic, pluripotent cell therapies. The crux of the discussion is that when developing a cell therapeutic, it is critical to look as much as a decade ahead to when FDA approval will be sought to commercialize the product through a biologics license application (BLA). While this discussion focuses on FDA approval of cell therapies, it is important to acknowledge the vast number of cell therapy clinical efforts…

Scalability of Lentiviral Production with the CTS LV-MAX Lentiviral Production System in Bioreactors

The Gibco™ CTS™ LV-MAX™ Lentiviral Production System provides a scalable and high-yield lentiviral vector (LV) production platform. It is based on a high-density suspension culture of HEK293F–derived Viral Production Cells that have been optimized for viral production in chemically defined LV-MAX Production Medium. Scalable LV production of greater than 1 x 10⁸ TU/mL LV (unconcentrated) can be achieved using our proprietary lipid nanoparticle transfection reagent in combination with an LV-specific enhancer and production supplement. All components work synergistically to help…

CMC Testing Support for Gene and Cell Therapy

Eurofins BioPharma Product Testing supports the development of ATMPs both for traditional use as well as for use in personalized medicine. We provide comprehensive GMP-compliant CMC testing support to ensure the identity, potency, purity, and safety of starting materials, intermediate products, vectors, and final drug products as well as support for manufacturing process development and validation. Testing Capabilities include Raw Materials, Cell Banks, Virus Banks, Plasmid Vector, Harvest (Lot Release Testing), and Bulk & Finished Products. We support gene therapies,…

Automated PBMC Isolation and T Cell Wash and Concentration by the CTS Rotea System

Successful processing and manufacturing in cell and gene therapy workflows are essential to the efficacy of the product. Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Certain steps in these workflows could benefit from optimized automation to decrease hands-on time and the cost of the cell manufacturing process. In this application note, we present the Gibco™ Cell Therapy Systems™ (CTS™) Rotea™ Counterflow…

Integrated Generation and Characterization of CAR T Cells

Chimeric antigen receptor (CAR) T cell therapies have been approved by the FDA and other global public health agencies to treat B cell leukemias and have seen great clinical success. Autologous CAR T cell manufacturing involves isolating T cells from a patient, activating these cells, introducing an engineered CAR construct, and expanding the cells to a scale appropriate for therapeutic dosing. Patient samples from multiple sources result in inconsistent clinical outcomes and overall product quality. To ensure patient safety and…

Effectively Securing Cell and Gene Therapies with Closed Systems

With their innovative new treatments, cell and gene therapies (CGT) are growing rapidly. But their traditional production processes don’t allow the supply of these therapies to keep up with demand. Historically, these therapies are produced for small patient populations in clinical trials using laboratory scale equipment and utilizing manual, open processes completed under laminar hoods. But manufacturers looking for more efficiency and flexibility are turning to new solutions. One key area of interest is the implementation of a closed system…

Ten important lessons the cell and gene therapy industry can take from the bioprocessing industry

It’s time to tackle the challenges of sustainable and cost-effective commercial manufacturing regarding cell and gene therapy. Cell and gene therapies have many of the same manufacturing needs as biopharmaceuticals. As a result, industry experts expect single-use technologies used in biopharmaceutical clinical trials and commercial production to play a larger role in the future development and production of cell and gene therapy. Single-use systems are already incorporated in the development of cell and gene therapies today. However, many of those…

Directed Differentiation of cGMP Compliant Human Induced Pluripotent Stem Cells Into Clinically Relevant Specialized Cells From All Three Germ Layers

The generation of human induced pluripotent stem cells (iPSCs) via reprogramming technology represents a major breakthrough in personalized medicine and the treatment of degenerative diseases. This is mainly because the iPSCs can be expanded in culture and then differentiated into specialized cell types that can be used for clinical applications. Patient-derived iPSCs can be used to model human genetic diseases, produce clinically relevant differentiated cells that display disease pathogenesis, or generate specialized cells through directed differentiation process for autologous cell…

Top 10 Human Tissue Supplier Considerations for Allogeneic Cell Therapy Development

The rapidly developing global cell therapy market poses numerous industry challenges for drug development, process scalability, commercialization, and patient safety. The processes of procuring human tissue for clinical applications are fraught with many technical, ethical, and legal issues. Allogeneic cell therapies involving primary cell types such as bone marrow mesenchymal stromal/stem cells (BM-MSCs), hematopoietic stem and progenitor cells (HSPCs), and T and NK cells for immunotherapy applications are especially challenging due to the vigorous process of screening and qualifying human…

Assuring Multipotency of human Mesenchymal Stem Cells (hMSC)

Over the past decade, stem cell research has provided new avenues for deeper investigation into tissue repair and aging processes, as well as regenerative medicine methods. One of the major players in such research endeavors are mesenchymal stem cells (MSC), also known as mesenchymal stromal cells. MSC are typically found in bone marrow, adipose, placental, and umbilical cord tissues1 and are a type of adult stem cell. In vivo, these cells are headquartered in special microenvironments or “niches” in the…