Methods, apparatuses, and systems the screening, analyzing and selecting microorganisms from complex heterogeneous communities, predicting and identifying functional relationships and interactions thereof, synthesizing microbial ensembles based thereon, and forming and administering endomicrobial feed supplements are disclosed. Methods for identifying and determining the absolute cell count of microorganism types and strains, along identifying the network relationships between active microorganisms and environmental parameters, are also disclosed.

Provided herein are biomarkers that can be altered in the gut of a mammal having CDI. One or more biomarkers can be used to predict Clostridium difficile infection (CDI) treatment outcome (e.g., response to primary CDI treatment and/or risk of recurrence after primary CDI treatment) in a mammal (e.g., a human) having CDI. Methods for using one or more biomarkers can be used to predict response to primary CDI treatment in a mammal having CDI. Methods for using one or more biomarkers can be used to predict risk of recurrence in a mammal having CDI. Also provided are methods of treating CDI.

The present invention provides a system for monitoring a sterilization procedure. The system includes a sterilization unit for providing sterilization of at least one item, a biological indicator for producing a readable signal, the signal readable during the sterilization procedure, wherein the signal corresponds to the viability of the biological indicator and a reader for reading the signal from the biological indicator during the sterilization procedure for monitoring the sterilization real time. Furthermore, the present invention provides a method for monitoring sterilization featuring simultaneously exposing at least one item to be sterilized and a biological indicator to a sterilization medium, the biological indicator producing a measurable signal corresponding to its viability and simultaneously monitoring the signal from the biological indicator during the exposure to the sterilization medium to determine completion of effective sterilization of the at least one item.

A correlative finding between increased Clostridiales and/or Bifidobacteriales bacterial abundance in the gut and intestinal barrier maturation of preterm neonates at-risk for development of necrotizing enterocolitis (NEC) is disclosed. These findings form the basis for the methods of identifying preterm infants at risk for developing necrotizing enterocolitis (NEC), the methods of treating such infants, as well as the methods of characterizing intestinal permeability in preterm infants disclosed herein.

The present specification discloses SNAP-25 compositions, methods of making α-SNAP-25 antibodies that bind an epitope comprising a carboxyl-terminus at the P.sub.1 residue from the BoNT/A cleavage site scissile bond from a SNAP-25 cleavage product, α-SNAP-25 antibodies that bind an epitope comprising a carboxyl-terminus at the P.sub.1 residue from the BoNT/A cleavage site scissile bond from a SNAP-25 cleavage product, methods of detecting BoNT/A activity, and methods of detecting neutralizing α-BoNT/A antibodies.

The present specification discloses a retargeted endopeptidase pharmaceutical wherein the activity has been determined by the methods disclosed.

The present invention is directed to Clostridium difficile toxin-specific antibodies, compositions, and uses thereof. The anti-toxin antibodies may be specific for TcdA. The invention also includes methods of treating a Clostridium difficile infection, methods of capturing Clostridium difficile toxins, and methods of detecting Clostridium difficile toxins.

The present invention pertains to a polyclonal or monoclonal antibody specifically binding to BoNT/E-cleaved SNAP-25. Further, the invention provides a method for directly determining the biological activity of BoNT/E in cells, comprising the steps of: a) incubating cells susceptible to BoNT/E intoxication with BoNT/E for a time and under conditions which allow for the BoNT/E to exert its biological activity; b) fixing the cells and, optionally, permeabilizing the cells with a detergent; c) contacting the cells with at least a first capture antibody specifically binding to non-cleaved and BoNT/E-cleaved SNAP-25, and with at least a second capture antibody specifically binding to BoNT/E-cleaved SNAP-25, wherein the second capture antibody is an antibody of the invention, under conditions which allow for binding of said capture antibodies to the indicated substrates; d) contacting the cells with at least a first detection antibody specifically binding to the first capture antibody, under conditions which allow for binding of said first detection antibody to said first capture antibody, thus forming first detection complexes, and with at least a second detection antibody specifically binding to the second capture antibody, under conditions which allow for binding of said second detection antibody to said second capture antibody, thus forming second detection complexes, and wherein the first detection antibody is different from the second detection antibody; e) determining the amount of the first and second detection complexes of step d); and f) calculating the amount of SNAP-25 cleaved by BoNT/E in said cells by means of the second detection complexes, thereby determining the biological activity of BoNT/E in said cells. Furthermore, the invention relates to a kit for carrying out the method of the invention.

An aqueous composition includes (i) glutamate dehydrogenase from a bacterium of the Clostridium genus, (ii) a stabilizing compound that is a carboxylic acid having a carbon-based chain of at least three carbon atoms and comprising at least two —COOH groups, or a salt thereof, and (iii) any of a monosaccharide polyol, disaccharide polyol, or polymeric macromolecule in addition to the glutamate dehydrogenase. A process for stabilizing the glutamate dehydrogenase in order to maintain antigenic properties of the glutamate dehydrogenase includes stabilizing the glutamate dehydrogenase in the aqueous composition and maintaining the antigenic properties of the glutamate dehydrogenase during storage of the aqueous composition.

The present application provides stable peptide-based Botulinum neurotoxin (BoNT) serotype A capture agents and methods of use as detection and diagnosis agents and in the treatment of diseases and disorders. The application further provides methods of manufacturing BoNT serotype A capture agents using iterative on-bead in situ click chemistry.