Abstract: Transimmunization methods incorporating skin immunologic challenges are described for either selectively suppressing the immune response of recipients of transplanted tissue or cells or monitoring induced anti-cancer immunity. In one embodiment, skin from the transplant donor is allografted to the transplant recipient to induce an immunological response to the transplanted skin. A quantity of blood is taken from the recipient and treated to render the T cells in the blood apoptotic and to induce differentiation of blood monocytes into dendritic cells. The treated blood is incubated and administered to the recipient to induce formation of suppressor T cell clones which reduce the number of T cells attacking the transplanted tissue or organ. This tolerogenic approach can be complemented by also feeding the immature dendritic cells apoptotic or necrotic cells from the organ donor.

Abstract: The invention provides, among other things, lyophilized compositions of high surface area that comprise a protein and that reconstitute quickly and efficiently to solution of high protein concentration with minimal formation, if any, of foam, effervescence, bubbles, turbidity, or particulates that might be deleterious. The invention also provides, among other things, methods for making the lyophilized compositions. The invention in additional aspects also provides Raman Imaging Spectrographic methods for real time analyses of polymorphs in a sample using PLS algorithms. By way of particular example, the use of the method for the analysis of mannitol polymorphs is described, and the use of the analysis to determine optimum compositions and lyophilization methods for producing lyophilates of pharmaceutical proteins having a predefined distribution of mannitol polymorphs and having the aforementioned reconstitution properties is also described.

Abstract: Methods are presented for isolating and purifying proteins by adding a polyelectrolyte to a cell culture fluid, such as a harvested cell culture fluid, and precipitating a protein-polyelectrolyte complex or a complex of impurities and the polyelectrolyte.

Abstract: The present invention relates to a bi-specific antibody or antibody fragment having at least one arm that is reactive against a targeted tissue and at least one other arm that is reactive against a targetable conjugate. The targetable conjugate encompasses a hapten to which antibodies have been prepared. In preferred embodiments, the hapten is histamine-succinyl-glycine (HSG). In more preferred embodiments, the at least one arm comprises the CDR sequences of the HSG-binding 679 antibody. The targetable conjugate is attached to one or more therapeutic and/or diagnostic agents. The invention provides constructs and methods for producing the bispecific antibodies or antibody fragments, as well as methods for using them and kits comprising them.

Abstract: The present invention relates to a diagnostic method for identifying persons with genetically related hetero- or homozygous expression of the MR I variant of factor VII-activating protease (FSAP). The heterozygous or homozygous presence of an MR I polymorphism can be identified by a differential modulation of the FSAP activity.

Abstract: The present invention is generally directed to methods of producing an increase in the enrichment or recovery of preferred forms of IgG proteins. More particularly, the invention relates to subjecting preparations of such recombinant IgG proteins with a reduction/oxidation coupling reagent and optionally a chaotropic agent.

Abstract: The subject invention provides a process for measuring the relative potency of a test batch of glatiramer acetate. In addition, the subject invention provides a process for preparing a batch of glatiramer acetate as acceptable for pharmaceutical use.

Abstract: The invention provides a method for determining the efficacy of a TNF? inhibitor, such as a TNF? antibody, or an antigen-binding portion thereof, for treating ankylosing spondylitis (AS), using a collagen degradation biomarker and/or a synovitis biomarker.

Abstract: The present invention relates to a bi-specific antibody or antibody fragment having at least one arm that specifically binds a targeted tissue and at least one other arm that specifically binds a targetable construct. The targetable construct comprises a carrier portion which comprises or bears at least one epitope recognizable by at least one arm of said bi-specific antibody or antibody fragment. The targetable construct further comprises one or more therapeutic or diagnostic agents or enzymes. The invention provides constructs and methods for producing the bi-specific antibodies or antibody fragments, as well as methods for using them.

Abstract: A food comprising a mutant gliadin protein that comprises at least one mutation in the epitope 62PQPQLPY68 (SEQ ID NO:6), wherein the mutation decreases the ability of the epitope to induce a T cell response, or a fragment of the mutant gliadin protein wherein the fragment is at least 15 amino acids long and comprises the mutated 62PQPQLPY68 (SEQ ID NO:6) is provided herein.

Abstract: The present invention provides means to assess immune response profiles of populations. In particular, the present invention provides means to qualitatively assess the immune response of human populations wherein the immune response directed against any protein of interest is analyzed. The present invention further provides means to rank proteins based on their relative immunogenicity. In addition, the present invention provides means to create proteins with reduced immunogenicity for use in various applications.

Abstract: The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

Abstract: Provided are in vitro and in vivo methods for determining whether a patient with Fabry disease will respond to treatment with a specific pharmacological chaperone.

Abstract: The present invention is related to methods and compositions that are capable of immediately immunizing a human or animal against any molecule or compound. The present invention comprises an immunity linker molecule with at least two sites; (1) a first binding site that binds to an immune system molecule in a human or animal that has been preimmunized against the first binding site, and (2) one or more second binding sites that bind specifically to a desired compound or molecule. The first binding site and the second binding site(s) are linked by a linker portion of the molecule.

Abstract: A novel method for selectively removing leaked protein A from antibody purified by means of protein A affinity chromatography is disclosed.

Abstract: The present invention relates to methods of determining the immunogenic potential of a test product by comparing the immunogenic profile or fingerprint of the test product to the immunogenic profile or fingerprint of a reference product.

Abstract: In order to accurately and reliably quantitate HLE on the plasma membranes of the lymphocytes and mononuclear phagocytes, a test sample containing the lymphocytes and mononuclear phagocytes is initially treated with a first antiserum specific for CD4 receptors on the plasma membrane or with a second antiserum specific for chemokine receptors on the plasma membrane. Once the CD4 or chemokine receptors have been rendered non-reactive (competitive) relative to the HLE receptors (also “binding sites”) on the plasma membrane, the test sample is contacted with an immunoreagent specific for interaction with one or more of the HLE receptors on the plasma membranes of the lymphocytes and mononuclear phagocytes. The immunoreagent forms a complex with the HLE binding sites and produces a characteristic physical change in the lymphocytes and mononuclear phagocytes that can be monitored by anyone of a number of standard techniques, (e.g., confocal laser scanning microscopy and flow cytometry).

Abstract: Various system and method embodiments of the present invention are directed to separating target molecules from complex solutions by affinity column chromatography using organic-solvent-containing eluants. In one embodiment of the present invention, an eluant containing an organic-solvent is used, at a first pH, to remove non-target solutes and suspended entities from an affinity chromatography column. The pH of the eluant is then changed to a second pH, and the organic-solvent-containing eluant is used to elute target molecules from the affinity column chromatography.

Abstract: The invention relates to methods of modulating an immune response in a mammal by modulating the activity of J?33 T cells or of MR1 polypeptide in vitro, ex vivo or in vivo. The invention also relates to methods of regulating the activity of immune cells, particularly of T lymphocytes and/or B lymphocytes by regulating the activity of MR1 in vitro, ex vivo or in vivo. The invention further comprises methods of screening active compounds using MR1 or fragments thereof, or nucleic acid encoding the same, or recombinant host cells expressing said polypeptide. The invention also deals with a pharmaceutical composition comprising J?33 T cells, MR1 polypeptide or a compound that modulates the activity of J?33 TCR T cells or of MR1 polypeptide and a pharmaceutically acceptable vehicle or carrier. The invention further deals with methods of diagnosis for intestinal diseases related to a defect of the activity of said J?33 T cells or MR1 polypeptide.

Abstract: A method for detecting the specificity of activated lymphocytes is provided. The present method can be used to detect the specificity of activated lymphocytes in recipients or patients after organ transplantation or being infected by pathogenic microorganism or vaccination. The establishment of the present invention can not only timely diagnose rejection in organ transplantation, but also provide guidance for rational medicament administration clinically. Furthermore, the present invention provides an accurate and quick method to detect infectious diseases. It will be significant to achieve the goals of early detection, early quarantine, early treatment, thereby reducing infection rate.