The contribution of MALDI mass spectrometry in the field of bacteriology has been well established.

For several years now, Biomaneo has demonstrated through NeoSickle® solution the capacity of MALDI to meet the needs of large-scale screening when combined with automated data processing and interpretation IT solutions. The NeoSickle® solution enables the neonatal screening for sickle cell disease to be performed simply, quickly and with the same sensitivity as reference methods and cheaper.

NeoSickle solution is used to screen for sickle cell disease. In this context NeoSickle is an IVDDM which is placed on the market under the responsibility of its manufacturer, the company Biomaneo, after having affixed the CE mark, which is evidence of conformity to the essential health and safety requirements laid down by European directives.
The Neosickle solution is composed of :
- a kit with different reagents, two configurations are produced: NS540 (for automats with high throughput analysis) and NS96 (low throughput)
- a MALDI-MS, today three instruments are validated, Microflex (Bruker), and AXIMA (VITEK-MS Biomérieux) and 8020 Shimadzu. 
- a LIMS (Laboratory Information Management System) NeoScreening® to create a link between the different instruments and allow good traceability, A software e-NeoSickle®, which processes the raw data and interprets the results. 

The complexity of IVD certification in the case of our NeoSickle application comes from the link between the different elements. The quality controls used to validate the sensitivity of the method are qualified by the instrument and the software, which must themselves be qualified. In order to certify the entire NeoSickle solution, Biomaneo had to qualify the kit and the software in combination. Biomaneo was inspected by the ANSM Medication Safety Agency, which certified the CE marking and the technical file for the NeoSickle global solution.
 

A4Cell develops is based on functionalized silicon microchips with chemical probes to monitor intracellular physiological changes. SPAchips devices can be multiplexed with several biomolecules at the same time (fluorescent probes, DNA/RNA, peptides, etc) and are internalized by endocytosis without disturbing cellular viability; NO TOXIC FOR CELLS.  SPAchip is the perfect tool to analyze cellular process at real time for extended periods.

A4Cell proposes cellomic´s reagents based on SPAchip assays compatible with High Content Screening Platforms (HCS) or other single cell analyzers equipment presents in most Pharma, biotech or academic laboratories where are working in drug discovery, toxicologic studies, cell metabolism and other biomedicine fields. We offer CYTOCHECK SPAchip® detection kits. 
Our Cytocheck SPAchip detection kit offers low toxicity, need low probes concentration, cell tracking for long time, high number of parameters detecting simultaneously and are using in living single cells.

The market for A4Cell products is High Content Screening (HCS) market (that includes any method used to analyze whole cells or components of cells with a simultaneous readout of several parameters.) which has a growing demand on new tolls for living single cells, A4Cell offer the UNIQUE TOOL for tracking living single cells AT REAL TIME. 

The main users of HCS and image analyzers platforms is looking for new and more innovative assays related SPAchip advantages (no toxic for cells, possibility to analyze several parameters at once, tracking cell process and much more). The business strategic will be to produce kits compatible with these platforms (main presents on the market xe Agilent, Biotek, Cytek, Synentec, etc) and commercialize them through these companies that are already operating in HCS market. SPAchip technology will offer them high added value products to increase their offer

The life of a product comprises different stages from the original idea to its commercialization. A very important step for the overall success of the product, is the transition from the design to the manufacturing process. 

The expected sales figures are not usually reached in real life. So, is it worth to invest in an automated manufacturing plant? Could it be better a lower risk option offered by a Contract Manufacturing Service? 

If you have ever considered this, all the key points for a successful and cost-effective transfer process from small to high scale production will be shared based on our practical cases experience.

AnteoBind™ uses multiple dative bonding and coordination chemistry, and combines the ease-of-handling of passive adsorption with the strength of binding of covalent chemistry, providing superior performance for bioconjugation applications in Life Science. We will introduce AnteoBind™ nanocoating technology and the use of AnteoBind™ activated Estapor® europium microspheres in development of lateral flow immunoassays. We will also discuss the common issues encountered in antibody conjugation, the alternative protein conjugation procedure using AnteoBind™ activated Estapor® europium microspheres, and the effects of physical characteristics (particle size, dispersity, surface charge) during the steps of conjugation and storage. We will also present the performance of these conjugates in functional assay development for viral infectious diseases and Sepsis.
 

Virion\Serion presents a novel recombinant Rubella spike ectodomain (E1-E2) antigen in comparison with established IVD Rubella IgM assays. The IgM antibodies are detected on magnetic beads coated with the new recombinant Rubella antigen and a fluorescent read-out system.

Rubella is a contagious viral infection typically occurring in childhood and mostly causing mild symptoms only. Rubella virus infection during pregnancy, however, can cause congenital Rubella syndrome with serious damage to unborn babies. The global incidence of Rubella is approximately 100,000 cases per year, manifesting mainly in Southeastern Asia, India, China and Africa. Detection of Rubella IgM specific antibodies is used for monitoring infectious diseases associated with Rubella virus. Here, a new recombinant Rubella antigen based on spike E1-E2 ectodomain (patent pending) is used for the detection of Rubella IgM antibodies. The E1-E2 heterodimers on the viral surface are the major target for neutralizing antibodies during infection. So far two types of Rubella antigens are used in diagnostics - purified and inactivated Rubella virus lysates or recombinant Rubella-like particles (RLPs). Both antigens are costly in production and difficult in standardization. Also modifications of these Rubella antigens for optimization or adaption to specific diagnostic platforms, e.g. special coating or coupling strategies, are not feasible due to the nature of these antigens. In contrast the novel recombinant Rubella spike ectodomain (E1-E2) antigen can be produced in high yields in cell culture and can be genetically modified according to any specific need. That makes the novel antigen an excellent choice for advanced diagnostic systems for serology, like micro arrays, multiplex tests (beads/POCT) or chemiluminescent tests (CLIA). But the new Rubella antigen can also be used in conventional ELISA systems to replace the conventional antigens.

MagIA diagnostics presents a new POC system based on Small Magnetic Microspheres, combined with micro-magnets and fluorescent detection. The assay exploits high local gradients generated by micro-magnets to capture and trap locally immune complexes bound to magnetic microspheres and fluorescent antibodies.  

The immunological reaction takes place in a cartridge where reagents are integrated. A dedicated analyzer performs a fluorescent measurement within fifteen minutes. MagIA diagnostics strives to combine high sensitivity immuno-detection with low production costs, promoting affordable and reliable diagnostics accessibility in all regions of the world.  

The growing challenges of pandemic risk management for infectious diseases drives the need for decentralized diagnostic solutions. Most available diagnostic solutions are focusing on detecting a single parameter. However, the Center for Disease Control and Prevention estimates that about 10% of people in the United States infected with HIV are co-infected with Hepatitis B. More than 120 million high-risk populations need to be screened on an infectious disease panel in western countries alone. That is why HAS and WHO are both looking for assays providing full serological status on the 3 mains sexually transmitted diseases HIV, HCV and HBV.
Using capillary blood, MagIA diagnostics infectious diseases panel will detect pathogens that most commonly present a co-infection:  HIV, HCV and HBV.

We develop 2 kits that can be used alone or in combination 
Hepatitis B rapid screening assay (HBs-Ag, anti-HBs, anti-HBc) for the whole serological status on Hepatitis B (treat or vaccine).

Hepatitis C and HIV rapid screening assay (anti-HCV, anti-HIV, p24) for Hepatitis C seropositivity and early detection of HIV infection.

The rapid and accurate knowledge of the presence or absence of the related pathogens will help make timely decisions about treatment, vaccination, infection control, and patient return to work and fam

Chemiluminescent immunoassays (CLIAs) offer one of the best solutions for the quantification of low concentrations of specific analytes from a complex mixture for in vitro diagnostic industry. 

The assay format is similar to enzyme-linked immunoassays, usually based on heterogeneous assays where antibodies or antigens are immobilized on a solid phase but one of the components is conjugated with a chemiluminescent label. 

The benefits of CLIAs can be enhanced using magnetic beads as a solid platform which improves the separation of the un-bound reagents and reduces the interferences using a magnetic field. The CLIA assays based on magnetic beads together with chemiluminescent tagging of immunoreagents are widely used in high throughput automated platforms obtaining an amplified signal and decreasing the matrix interferences. 

The complexity of these type of immunoassays rely on the optimization of several components and parameters. The critical points are highly related to the type of immunoassay format that best suits the desired specifications, magnetic beads selection and conjugation conditions for magnetic particles and chemiluminescent labelling parameters.
 

The great popularity of magnetic separation is due to its simplicity. The first attempts at a small volume usually work fine even with a simple magnet but for the manufacturing of commercial products, it is necessary to work at several liters scale. To do this is important to correctly identify that the key parameter for biomagnetic separation is the magnetic force not the separation time nor the magnetic field. As consequence, using a simple magnet (or an open structure) the magnetic force is not well defined, then we cannot validate the working conditions. By contrast, using biomagnetic separation systems with constant magnetic force the separation speed will be constant, regardless of the working volume. Keeping the magnetic force constant also guarantees no aggregation problems at any volume due to excessive retention force. The resultant separation time would be just proportional to vessel diameter, but the production volume will increase as D3, then it will do the productivity. Moreover, larger consistent batches would reduce labor & QC burden.

The biomagnetic separation process needs to be monitored to determine the separation time for a given volume and, for checking the batch-to-batch consistency. One option is the real-time measurement of absorbance. If the magnetic force is constant, any alteration in the optical curve of the separation process will be caused by changes in the suspension (beads aggregations, changes in the buffers, different kinds of beads, and/or its concentration). 
In consequence, we can conclude that the 3 keys for a smooth scale-up of your biomagnetic separation process are the use of constant magnetic force systems, monitoring the separation process, and to keep the same magnetic force at the different volumes