Cell Therapies

Your Ultimate Guide to CMC Testing Support for Gene and Cell Therapy

The development of Advanced Therapy Medicinal Products (ATMPs), such as gene and cell therapy products, has made significant progress in the treatment of many diseases, including cancer, genetic, and autoimmune disorders. With the promise to enhance treatment, greatly reduce side effects, and potentially cure many types of diseases and disorders, these therapies are in high demand, and biopharma companies are in a race to the clinic. However, these technologies are very complex in nature and are vastly different than traditional…

Cell Harvesting & Washing: Optimizing Viability and Recovery in Cell Therapy

The cell harvesting step is of utmost importance for cell therapy manufacturers. During this step, high cell viability and recovery are important to maximize yield. Single-use, low shear closed-system centrifuges enable safe and efficient cell therapy manufacturing through the efficient recovery of viable cells. Additionally, in the production of cellular-based therapies, media and buffer are often used to remove unwanted proteins, serums, and debris prior to the eventual administration to patients or for research and treatment purposes. Download this case…

Integrated Solutions for Advanced Therapies

Cell and gene therapies have reached clinical and commercial success as evidenced by the steady number of first approvals over the past four years. Drug developers face mounting challenges linked to rapid increases in demand for the complex modalities while also accounting for the need to drive process efficiencies at scale. Working with the right partner, that offers integrated services, can help ease the increasingly common problems with scale, access to high-demand raw material, viral vector production, and quality requirements.…

From Concept to Cure: Using AAV in Gene Therapy

Because viruses efficiently insert nucleic acids into host cells upon infection, they are attractive vehicles for gene delivery. In the past, many viral gene delivery agents were unsuitable for clinical applications due to their high immunogenicity and propensity to cause cancer. To bring gene therapy to the clinic, scientists now use adeno-associated viruses (AAVs) for safe and effective gene delivery. Download this ebook from Bio-Rad to learn about Techniques for developing safe and effective AAV vectors for gene therapy Characterizing…

Leading Biopharma Uses Linkit® AX: Here are the Results

A Leading Biopharma was looking for a way to speed up their CAR-T media preparation. Their manual aliquoting process was time intensive, had a high risk of error and inaccuracy, and lacked a strategy for scaleup to a GMP environment. Sartorius developed a semi-automated media blending and aliquoting solution – the Linkit® AX Aliquoting Solution – that has been implemented and is now part of a GMP CAR-T manufacturing process. Read about how they used Linkit® AX to achieve 10x…

Resource Roadmap to Screening Success: Cell-based Therapy Edition

Due to the tight link between cell culture conditions and final product quality attributes, thorough evaluation of raw materials and process parameters is critical to the development of cell-based therapies. Screening a wide array of process inputs using conventional methods and variable reagents can be costly and time consuming. This Resource Roadmap illustrates the use of the Sartorius Screening Ensemble to enable broad exploration early in development while also accelerating experimental design, execution, and validation Read this Resource Roadmap to…

Improving Titer, Quality and Efficiency of AAV Manufacturing and Production by Optimizing Osmolality

The rate of innovation within Cell and Gene Therapy is incredible and will continue to grow at an exponential rate as new methodologies are developed. With the novel techniques, come new and improved manufacturing procedures for sought after therapies. The use of viral vectors is now a common approach within the sector, but there are still difficulties when scaling up for bioprocessing. An example being a recovery range of 5-30%, a less than optimal result within the manufacturing process. When…

Revolutionizing Cell Culture with Cryopreserved Pre-Plated Cell Monolayers

Cell monolayers are an ideal method and widely used in the discovery of new drug compounds and the study of cell biology. Until now, there was no cryopreservation technology available to store cell banks pre-plated commercially. The conventional approach of cell-based assay workflow was time- and resource-consuming. Now, the cryoprotectant technology CryoShield™ from CryoLogyx together with the controlled and scalable plate freeze-thaw platform RoSS.pFTU from Single Use Support, mark a revolution in commercial cell banking: Cryopreserved Thaw and Use Cell…

Application Note: Early-Stage Process Optimization for Seamless Scaling of MSC Therapies

A single dose of MSC therapy could consist of billions of cells per patient. To sustainably meet this clinical demand, cell expansion processes must be transformed from static cultures to suspension-based systems. This application note describes an efficient approach to process optimization in a scale-down model for suspension-based cell expansion. Read more to learn how to: • Comprehensively screen media and components for optimal cell growth • Rapidly characterize phenotypic and functional CQAs of MSCs • Develop process knowledge early…

Autologous CAR T-Cell Manufacturing Using a Semi-Automatic, Closed, Modular Workflow

There have been tremendous efforts to make CAR T-cells more effective, safe, and persistent when treating patients. On the manufacturing side, however, errors, lot-to-lot variation, and contamination can be associated with open processes and manual handling of CAR T-cells. Cell isolation, gene editing, expansion, and cryopreservation are complex steps in a typical autologous CAR T-cell manufacturing process. Integrating this complicated multistep workflow into a closed, modular, benchtop system can facilitate transitions from laboratory scale to clinical manufacturing and improve the…