Don’t miss our top Cool Tools of 2021! I have compiled a list of our 10 most popular Cool Tools for 2021 in alphabetical order.

Bio-Techne’s GMP ProDots Proteins™: Closing the Loop in Cell Therapy Manufacturing

As cell therapy manufacturing continues to grow, patient safety is at the core of developing robust and efficient manufacturing processes. The ability to close the manufacturing process mitigates the risk to the final therapeutic and ensures an efficient, de-risked, cost effective process. To close the gap on the addition of critical cytokines into the process, Bio-Techne has developed GMP ProDots™ Proteins, lyophilized spheres of protein inside single-use sterile, weldable bags that can be directly integrated into closed process systems…

Cell-Vive™ Replaces Human Serum and Optimally Cultures T and NK Cells

Cell-Vive™ T-NK Xeno-Free Serum Substitute, GMP is specifically formulated to proliferate T cells and Natural Killer (NK) cells for cell therapy manufacturing. Among the most promising cancer treatments is cellular immunotherapy, which can involve the use of a patient’s own T and NK cells, to target and eliminate cancer. Source cells, such as peripheral blood mononuclear cells (PBMCs), are isolated from a patient’s blood. T cells are then activated using anti-CD3/CD28 antibodies and cytokines, followed by cell culturing and expansion. After expansion, grown T cells undergo quality control to ensure they match the necessary requirements, such as cell identity and high yields needed for immunotherapy (Fig 1). Finally, cells are then infused back into the patient as therapy, or cells are cryopreserved for later use at a treatment facility…

CelVivo’s ClinoStar can grow organoids or spheroids that mimic the function, structure, and architecture of in vivo cells

It has been demonstrated over the past several decades that three-dimensional (3D) cell culture provides a superior system for mimicking the in vivo environment. Historically, flat, two-dimensional (2D) monolayer cells were the only practical option available, however, they are seriously limited in their ability to recapitulate normal tissue responses because they lack tissue-specific cytoarchitecture, in vivo mechanical and biochemical cues, and cell-to-cell interactions. Spheroids and organoids have emerged as a more physiologically relevant model for in vivo cellular responses. These more complex models improve upon cell-line and primary cell-based methods with their ability to mimic native cytoarchitecture and to display physiological attributes of the native tissue. However, they can be difficult to culture for long periods of time, while maintaining human in vivo physiological performance. In addition, they often have size and shape variability, and poor viability…

Expedite Media Optimization with Viral Vector HEK Media Panel

Among viral delivery systems, recombinant adeno-associated viruses (AAVs) have become the preferred vector for gene therapy because of their high transduction efficiency, safety profile, and long-term gene expression. The increasing number of gene therapy programs has increased the demand for these viral vectors in a clinical setting despite recent setbacks. However, AAV production in a GMP setting at the required yield and purity needed to meet expanding clinical demand remains a hurdle with current production systems and global capacity…

The NevoLine™ Upstream platform provides intensified and automated large scale virus manufacturing in a compact footprint

Virus manufacturing is key to many therapeutic applications, including viral vectors for gene therapies, viral vaccines, and immuno-oncology. The demand for those therapies is growing exponentially pushing for new production capacities. However, producing these therapies using traditional technologies face several limitations including, scalability, the need to be flexible enough to accommodate a range of products with ease and manufacture at reasonable costs. In the vaccine market the Covid-19 crisis is currently demonstrating the need for fast and flexible capacity deployment of virus manufacturing to adapt to different vaccine candidates currently developed by the scientific community…

OCELOT™ System Control Provides Flexible Automation for Process Precision

The biopharma industry has continued to embrace automation as a key part of creating more efficient, cost-effective manufacturing. There are many options for how to automate systems, but a universal requirement is the need for a responsive, built for purpose automation software. In most cases automation software provides a single interface for all applications, while this may seem convenient, it often can’t be configured to meet an end users’ exact process or mode of operation…

Rapid and robust AAV characterization

Adeno-associated virus (AAV) vectors are the most widely used gene delivery systems for new and established gene therapies due to their effectiveness at transferring beneficial genetic material into dividing and non-dividing cells with low pathogenicity and flexible tropism to target different tissue types. Because of their utilization in cell and gene therapeutics intended for patient use, governing regulatory bodies hold viral vector manufacturers to a high standard with the expectation that extensive product characterization is performed to ensure product safety and efficacy. The FDA’s chemistry, manufacturing and control (CMC) guidelines state that manufacturers must prove the identity, strength/potency, purity, safety and stability of their viral vectors…

Rapid stability screening of AAV capsids and formulations

Vectors derived from adeno-associated viruses (AAV) are one of the most popular tools for gene therapies, immunotherapies and vaccines owing to their safety profile, efficient infection of dividing and non-dividing cells and stable maintenance of the viral genome without integrating into host cells. In the production of AAV vectors many variables can impact their stability, yield and, ultimately, their infectivity. Therefore, a detailed understanding of how factors such as the serotype, formulation, manufacturing method, and storage conditions impact AAV stability is essential for process development…

The scale-X™ carbo bioreactor: flexible GMP viral production at bench scale in adherent or suspension processes

Producing viral products for vaccines or cell and gene therapy starts with cell culture, where bioprocessing equipment must be selected to ensure conditions established at bench-scale can be successfully translated to the clinics and onwards. A successful development and manufacturing platform must result in low cost of goods for the final product, high design robustness (low risk of failure) and ease of use and scale-up…

Stunner quantifies RNA and lipid nanoparticle size distribution for RNA vaccines

The development and manufacture of mRNA lipid nanoparticle (LNP) vaccines in record time is a testament to the incredible potential of emerging therapeutics in medicine today. Not only is this technology delivering on the herculean task of subduing a raging pandemic, but it is also being explored in vaccines for other infectious diseases and as treatments for cancer, multiple sclerosis, cystic fibrosis and others. As we look toward scaling and streamlining the production of RNA-LNP vaccines, it is important to evaluate how to improve the overall process. RNA-LNP therapeutics are complex to develop and accurate analytics are a key part of development and final release. Two key analytical techniques with room for improvement are RNA concentration and size distribution of lipid nanoparticles (LNP), which are the quality and efficacy of RNA-LNP vaccines…