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Science  06 Dec 2013:
Vol. 342, Issue 6163, pp. 1262
DOI: 10.1126/science.342.6163.1262-a


The new Cellmate Mk9 automated cell culture system is designed for safe, high throughput production of adherent cell-based vaccines in a GMP environment. Cellmate Mk 9 is an evolution of the well-established Cellmate technology that automates the manufacturing processes associated with production of vaccines using adherent cell-based methods in roller bottles and T-flasks within a Class 100 laminar airflow cabinet. The latest Cellmate system can be UL certified and includes an inline particle counter that can be used to monitor non-viable particle loading in the processing area. The inline particle monitoring helps address increasing demands from regulators for assurance about the environmental quality used in manufacturing processes. Cellmate Mk9 supports the OPC interoperability standard for industrial automation allowing users remote access to process information. The Cellmate software retains 21 CFR Part 11 compliance and TAP provides full support for IQ and OQ, which makes implementing Cellmate into GMP vaccine production facilities a straightforward task.


The new PluriSTEM Human ES/iPS Medium is designed for the routine expansion of human embryonic and induced pluripotent stem cells in feeder- and serum-free conditions with less frequent feeding and cell culture time. It is the first human ES/iPS media to combine small molecule inhibitors with pluripotent specific growth factors and supplements to enable a less rigorous cell culture regiment. The medium consists of fourteen components and is fully defined. The proprietary formulation includes Activin-A, TGFβ1, and b-FGF to promote stem cell self-renewal and potent small molecule combinations to inhibit unwanted spontaneous differentiation as well as human serum albumin (HSA) to aid in overall colony morphology. The culture of human ES/iPS cells has traditionally required feeding every day, including weekends, as well as significant technical expertise. This new medium addresses these challenges by providing an efficient and robust culture method that allows for feeding every other day, excluding weekends.


New Alexa Fluor 405/568/750 conjugated secondary antibodies have been added to the existing Alexa Fluor 488/555/594/647 conjugates. The Alexa Fluor range guarantees bright staining and low background. The different color variants were selected to provide an increased selection for multicolor staining. The Alexa Fluor portfolio comprises antibodies raised against mouse/rabbit/rat/chicken/goat/sheep/guinea-pig IgG and against mouse/rabbit IgM. It also includes a large selection of pre-adsorbed/cross-adsorbed and F(ab')2 fragment secondaries to ensure low species cross-reactivity. A dilution range of 1/200 -1/1000 in IF/ICC allows for at least 250 stainings per product to improve cost efficiency. The Alexa range expansion adds a blue emitting fluorophore, Alexa Fluor 405, and a near IR dye, Alexa Fluor 750. The addition of Alexa Fluor 568 is ideal for confocal laser-scanning, as most of these microscopes have a 561 nm laser, which optimally excites the Alexa Fluor 568 dye. Alexa Fluor secondaries are ideal for multicolor staining.


Developed as an alternative to B27, GS21 is a next generation serum-free neural media supplement, based on the formulation of NS21 Supplement, designed to improve the overall growth and performance of primary neurons. GS21 has been specifically optimized for the maturation and long-term viability of primary rat and mouse neurons in culture, without the need for co-culture with astrocyte feeder cells. In experimental tests, GS21 has been shown to significantly improve long-term viability of rat and mouse primary neurons in vitro as well as enhance neurite outgrowth of primary neurons in culture. Beneficially, GS21 also supports growth and maintenance of primary neurons at low or high cell density plating.


Xuri is a new technology family designed specifically to support and advance the field of cell therapy. Cell therapy and regenerative medicine, the use of cells to replace damaged tissue or to treat disease, shows great promise for treating many life-threatening and life-limiting illnesses. The widespread adoption of these therapies will require the development of robust, scalable manufacturing tools and workflows to generate sufficient, high-quality cells for infusion into patients. With an estimated 2,500 on-going cell therapy and regenerative medicine clinical trials worldwide, many research groups are now looking at how to move from small-scale expansion of cells to a cost-effective, industrialized process. GE Healthcare's new Xuri Cell Expansion System W25 is a functionally closed, automated system, specifically designed to be suitable for the requirements of scaling-out cell therapies in a clinical setting. The system is equipped with dedicated software applications to make it suitable for a regulated manufacturing environment and has been validated for T-cell growth. The Xuri W25 builds on the GE Healthcare's WAVE Bioreactor technology which is widely used in the development and manufacture of biopharmaceuticals globally.

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