Abstract: Methods of removing high molecular weight species, in particular aggregates, from antibody drug conjugate preparations, by contacting preparations of the antibody drug conjugate reaction mixture with a hydroxyapatite resin and selectively eluting the ADC from the resin using a gradient comprising sodium phosphate.

Abstract: It was discovered that, by preparing an Fc region of an Fc region-containing polypeptide in which the first polypeptide chain of the Fc region binds to a Protein A resin, but the second polypeptide chain of the Fc region does not bind to the resin or shows weak binding to it, the amount of the Fc region-containing polypeptide bound per volume of the resin is increased, and more efficient purification of the above-mentioned Fc region-containing polypeptide is possible.

Abstract: The present invention provides novel and improved protein purification processes which incorporate certain types of carbonaceous materials and result in effective and selective removal of certain undesirable impurities without adversely affecting the yield of the desired protein product.

Abstract: The present disclosure provides methods to quantify tau phosphorylation at specific amino acid residues to predict time to onset of mild cognitive impairment due to Alzheimer's disease, stage Alzheimer's disease, guide treatment decisions, select subjects for clinical trials, and evaluate the clinical efficacy of certain therapeutic interventions.

Abstract: A process for synthesizing and separating secretory IgA from a mixture of IgA monmer and IgA dimer is provided. The process includes covalently binding affinity tagged or epitope tagged recombinant secretory component to the IgA dimer in the mixture and binding the affinity tagged or an epitope tagged secretory IgA to immobilized moieties on the solid phase support resin to which the affinity tag or epitope tag binds and then eluting the affinity tagged or an epitope tagged secretory IgA with release buffer. A process for synthesizing and separating secretory IgM from a mixture of IgM and other plasma proteins is also provided. The process includes covalently binding affinity tagged or an epitope tagged recombinant secretory component to the IgM in the mixture and binding the affinity tagged or an epitope tagged secretory IgM to immobilized moieties on the solid phase support resin and then eluting the peptide tagged secretory IgM with a release buffer.

Abstract: The present disclosure relates to a bio-manufacturing process that enables continuous production of a therapeutic protein with reduced heterogeneity. The bio-manufacturing process disclosed herein utilizes a multi column chromatography system that performs the unit operations of reducing heterogeneity in a therapeutic protein, capturing the therapeutic protein and inactivating viruses, purifying the therapeutic protein, and polishing the purified therapeutic protein. The process disclosed herein can reduce heterogeneity of a therapeutic protein by reducing a proportion of basic isoforms of the therapeutic protein.

Abstract: The present invention relates to a method for promoting diversification of variable regions of an antibody. Specifically, the present invention relates to a method for promoting diversification of the amino acid sequences of variable regions of an antibody generated by an avian B cell population, wherein the method comprises suppressing the PI3K? activity of each avian B cell comprised in the avian B cell population expressing the antibody.

Abstract: The present invention relates to a method of purifying a recombinant polypeptide from Host Cell Proteins (HCP), the method comprising: (a) applying a solution comprising the recombinant polypeptide and HCP to a superantigen chromatography solid support, (b) washing the superantigen chromatography solid support with a wash buffer comprising caprylate and arginine; and (c) eluting the recombinant polypeptide from the superantigen chromatography solid support.

Abstract: The invention provides for the removal of a large fraction of contaminants from protein preparations while maintaining a high level of recovery using tentacle anion exchange matrix chromatography medium. Using the methods of the invention, leached affinity chromatography contaminants can be removed from recombinant protein preparations.

Abstract: The invention provides a method for controlling contaminants in biopharmaceutical purification processes by using light scattering and UV absorbance to establish a determinant. The invention makes use of multi-angle light scattering (MALS) and UV as a continuous monitoring system to provide information about the elution peak fractions in real-time instead of conventional pooling methods that rely on a predetermined percent UV peak max value to initiate the pooling process; regardless of product quality.

Abstract: The present invention provides a process for the recovery and/or purification of a recombinantly expressed intracellular protein comprising the sequence of Annexin A5 (AnxA5) from an endotoxin-producing host cell with a cell wall, wherein the process comprises releasing the intracellular protein from the host cell, characterised in that the step of releasing the intracellular AnxA5 protein is conducted in the presence of a homogenisation buffer comprising non-ionic detergent, and preferably wherein the process does not include any centrifugation steps for the recovery and/or purification of the AnxA5 protein after its release from the host cell and/or in which the AnxA5 protein remains in solution throughout the process except when temporarily bound to any chromatographic resins.

Abstract: The present disclosure relates to methods of re-oxidizing an antigen-binding protein.

Abstract: The invention involves, inter alia, the use of markers of systemic inflammation to determine whether or not an individual undergoing treatment with a cardiovascular agent to reduce the risk of a future cardiovascular event will benefit from continued treatment with the cardiovascular agent. Further, this invention describes the use of markers of systemic inflammation to evaluate the efficacy of treatment and to assist physicians in deciding on the course of a treatment in an individual at risk of future cardiovascular events.

Abstract: Provided herein are compositions, including pharmaceutical compositions, and methods for modulating, i.e., stimulating or inhibiting, activity of the alternative complement pathway, and methods of identifying factor H-binding proteins.

Abstract: The present disclosure provides methods to quantify tau phosphorylation at specific amino acid residues to predict time to onset of mild cognitive impairment due to Alzheimer's disease, stage Alzheimer's disease, guide treatment decisions, select subjects for clinical trials, and evaluate the clinical efficacy of certain therapeutic interventions.

Abstract: The invention relates to the generation of multispecific antibody mixtures include a subset of antibodies isolated from a mixture of two or more monospecific antibodies and one or more bispecific antibodies, wherein all antibodies in the subset have the same common heavy chain. The invention also relates to methods of isolating, purifying, or otherwise producing such a subset of antibodies by using at least one affinity chromatography step. The invention also relates to methods of using such a subset of antibodies in a variety of therapeutic indications.

Abstract: The present inventors discovered that antibodies having weaker antigen-binding activity at the early endosomal pH in comparison with that at the pH of plasma are capable of binding to multiple antigen molecules with a single antibody molecule, have long half-lives in plasma, and have improved durations of time in which they can bind to antigen.

Abstract: Processes and methods of purifying or separating Single Domain Antigen Binding (SDAB) molecules that include one or more single binding domains (e.g., one or more nanobody molecules), substantially devoid of a complementary antibody domain and an immunoglobulin constant region, using Protein A-based affinity chromatography, are disclosed.

Abstract: Neutralizing antibodies through recombinant protein expression were identified by mining antibody repertoires by high-throughput second generation sequencing. Sequencing across the majority of light and heavy chain variable regions of chicken immunoglobulins was performed at two immunological time points: a non-immune (naive) state and a post-hyperimmunization state. The mRNA was extracted from unsorted and unselected PBMC populations and identification of antigen-specific antibody sequences leveraged the significant disparity of abundance of an individual B cell clone in non-immune and immunized states. Through bioinformatic analysis, candidate amino acid sequences for variable heavy chain and light chains were identified. Recombinant polypeptides with the binding domains having the identified amino acid sequences for variable heavy chain and light chains were expressed and screened using immunoassays to confirm antigen-specificity.

Abstract: The present inventors discovered that antibodies having weaker antigen-binding activity at the early endosomal pH in comparison with that at the pH of plasma are capable of binding to multiple antigen molecules with a single antibody molecule, have long half-lives in plasma, and have improved durations of time in which they can bind to antigen.