I have compiled a list of our most popular Cool Tools Features for 2017. Here are the top 15 in alphabetical order.

Cool Tool – Biomek i-Series – Next Generation Automated Workstations Specifically Designed to Meet Evolving Workflows

Automation is a hot topic lately as it has the potential to overcome key hurdles in both research and biomanufacturing. It is being utilized to provide high throughput, reduce labor requirements, increase consistency and eliminate bottlenecks…

Cool Tool – A Complete System for Viral Vector and Recombinant Protein Production in HEK293 Cells

HEK293 cells are easy to grow in culture and commonly used for transfection to produce recombinant protein or gene products. Transfection of HEK293 cells is prevalent due to the fact that they are easy to transfect with high efficiency, and in the right culture environment, can achieve high levels of expression quickly. Two applications with widespread use of HEK293 cells are viral vector production for gene therapies and recombinant protein production…

Cool Tool – Efficient single cell isolation and proof of clonality in one step

Cell line development is a crucial part of biomanufacturing and sets the stage for future success by enabling the discovery of high yield and high quality clones. Within the cell line development workflow, one of the most critical steps is single cell isolation. The goal is to culture single cells in individual wells, which is necessary to ensure clonality. The FDA requires proof of clonality and companies must provide evidence that each cell line used in manufacturing has been generated from a single cell. This verification typically involves a combination of statistics and images to provide the required evidence…

Cool Tool – Fluid Transfer Sets Specifically Designed for Sterile Transfer of Cell Therapy Based Products

As the Cell Therapy industry increasingly moves from research to clinical trials and commercial manufacturing, it is necessary to scale up manufacturing processes to meet increasing product demand. Clinical and commercial manufacturing also requires that the manufacturing process be compatible with quality and regulatory expectations to ensure safety…

Cool Tool – Generation of Neural Stem Cells from AlphaSTEM Cultured Pluripotent Stem Cells

Patient-derived induced pluripotent stem cells (iPSCs) offer exciting potential for disease modeling, regenerative medicine, and therapeutic development. In order to fully realize the potential of iPSCs, it is critical to develop culture and differentiation methodologies that result in the most biologically relevant terminal cells (e.g. Neurons)…

Cool Tool – Improved, High Quality Poloxamer 188 Produces Consistent Performance in Cell Culture

Hydrodynamic stress in bioreactors and specifically shear caused by sparging can present a challenging issue in commercial biopharmaceutical manufacturing. A solution was found in the use of Poloxamer 188, a surface-active, non-ionic polymer that when added to cell culture media acted as a shear protectant. Poloxamer 188 became a standard ingredient in cell culture media for commercial production. However, as cell culture technology improved including process intensification, which increased cell densities and productivities in fed-batch and perfusion modes, issues with poloxamer were reported. Issues included unexpected loss of cell density and viability in biopharmaceutical manufacturing. This loss could be traced back to lot-to-lot variation in the Poloxamer 188. This variation was a major problem and was the subject of several investigations to understand the source of the variation…

Cool Tool – Label-free kinetic characterization in the palm of your hand

Kinetic binding and characterization of biotherapeutic candidates is an important part of screening and selection during drug discovery. The ease and speed with which this information is obtained directly affects decisions about whether a candidate is suitable for further research. Thus there are important considerations to be made when choosing a method for analyzing biophysical data…

Cool Tool – Optimizing T cell media with animal component free, recombinant human serum albumin

There are an increasing number of T cell-based therapeutics moving through clinical trials. These immunotherapies hold tremendous promise and much of the clinical trial data has been impressive. As these therapies have progressed toward larger trials and commercialization, focus is shifting from proof of concept to consistent and sustainable manufacturing. In T Cell Therapy, a critical part of manufacturing requires that patients’ cells be expanded in culture to reach the desired dose. Thus, cell culture media is an important part of the process and must be able to both support cell growth and provide consistent results. In particular, there is a desire to move away from animal-derived and other undefined components in the media. These components can have lot-to-lot variability and increased risk of introducing adventitious agents. In addition, there is also concern around animal components and the effects accompanying cytokines/growth factors can have on cells…

Cool Tool – Optimizing Vero Cell Culture Media with animal component-free, recombinant human serum albumin

Vero cells are adherent cells that require a surface to attach to in order to proliferate and produce viruses. Production scale-up with adherent cells is generally more challenging than with suspension cell cultures due to the surface area and media formulation requirements. Vero cells grow well in a variety of vessels including flasks, cell factories, and microcarriers in bioreactors, however they must be supported in attachment and need a robust media to ensure good growth and productivity. Traditionally, vero and other virus producing cells have been cultured in serum-containing medium. However the vaccine industry is moving toward defined, animal component-free media for vero cell culture and vaccine production, much like the move CHO cell-based manufacturing made several years ago. Using media formulated without serum or animal components reduces risk of contamination with adventitious agents, streamlines regulatory documentation, and can increase consistency in culture…

Cool Tool – PRIME-XV® T Cell CDM – First Commercially Available Chemically-defined, Animal-component-free Medium for T Cell Culture

Gene therapies and immunotherapies hold tremendous promise to treat diseases in a completely novel way. As increasing numbers of these therapies move from research and proof of concept to clinical trials, the manufacturing requirements will become more complex. Part of this includes a desire to move away from media that contain animal-derived and undefined components to animal component-free and chemically-defined components. In addition to the possible safety issues, animal components can be variable from lot to lot. Animal components with their naturally occurring cytokines and growth factors can also result in undesired and unexpected effects on cells…

Cool Tool – Shape Matters – An Innovative Design for Single-use Bioreactors

For many years cylindrical stainless steel tanks have been used in biopharmaceutical production. The primary reason for the cylindrical shape was that it provided the mechanical stability required for high-pressure steam sterilization. In recent years single-use systems have become more widely adopted for many reasons including: reduced cleaning and validation time, improvements in cell culture productivity requiring less manufacturing volume, and flexibility. As single-use bioreactor vessels were developed, they adopted the same cylindrical shape as their stainless steel counterparts…

Cool Tool – SIDUS® technology for viral vector manufacturing

Viral vector-based products are new molecular entities and therefore the development of platform technologies, i.e. vector design, packaging systems, production procedures, purification methods, and release testing requirements are progressing while already assessing efficacy and safety aspects of viral vectors in clinical trials. It is therefore that companies developing viral vector products often seek support from external expert organizations to help develop a robust process and deliver clinical grade product while focusing internal resources on platform improvement technologies…

Cool Tool – A single cell dispensing unit for cell line development – taking the benefits of Limiting Dilution and combining with high seeding efficiencies

One of the most popular traditional cloning techniques is limiting dilution. The technique is cost-effective and has received regulatory acceptance for several years. In limiting dilution cloning, a mixed population of cells is diluted in liquid media and is dispersed into 96-well plates or other culture vessels. The goal of this method is to isolate individual cells into single wells or vessels. In order to accomplish this, the wells are seeded at an average density of less than one cell per well. While low seeding density increases the chance of isolating single cells into single wells, it also means that there will be more empty wells. Empty wells represent a waste of personnel time, consumables and lab space. Nonetheless, no matter how low the seeding density, some wells will still contain multiple cells or doublets. While the limited dilution method is still very popular, it is time consuming and labor intensive. With advancements in cell line development and successful alternatives available, many groups are looking to replace limiting dilution with more advanced and robust technologies…

Cool Tool – Xeno-free hematopoietic cell culture medium designed for use in cell-based therapy production

Hematopoietic stem and progenitor cells (HSPCs) hold tremendous therapeutic potential for use in cell therapies to treat blood cancers and other blood diseases including sickle cell anemia and immune related disorders. HSPCs most frequently are sourced from donor blood or bone marrow. These cells are rare with only 1 in 100,000 found in peripheral blood cells and 1 in 10,000 found in bone marrow. In order to achieve the dosage required for most cell therapies (100’s of millions), cells must be successfully expanded to high numbers in culture. However during expansion, cells must also maintain the progenitor cell properties including the potential to differentiate and mature into the various hematopoietic lineage cells required for therapeutics…

Cool Tool – Xeno-free media supplement for Cell Therapy Manufacturing

Cell-based therapy has demonstrated significant promise in the potential to treat some of the most challenging diseases. The recent FDA approvals of Novartis’ Kymriah and Kite Pharma’s Yescarta demonstrate the tremendous benefits this industry has to offer. As more and more cell therapies progress towards commercialization, safe and efficient manufacturing becomes critically important. Because the cell is the therapy, materials and methods used to culture the cells are a key focus of regulators. It is easy to become inundated by the plethora of reagents available on the market and risk mitigation strategies are becoming differentiators. Several companies have looked to serum-free culture in an attempt to remove the variability associated with using animal source sera. However, the ex vivo manipulation necessary for Cell Therapy manufacturing creates a more challenging system for the cells to survive in and thus they have a tendency to struggle in serum free conditions. If the cells aren’t growing well, then manufacturing can’t meet the efficiency or timelines required to create a viable product…