Abstract: The present disclosure provides a method for accurately measuring post-translational modifications in proteins such as antibodies. In particular, the method pertains to the use of heavy isotopic standards to generate a calibration curve to allow for accurate quantitation of a modified peptide. The method may be used to accurately quantify C-terminal truncation in antibodies using mass spectrometry.

Abstract: The present disclosure provides a method for accurately measuring post-translational modifications in proteins such as antibodies. In particular, the method pertains to the use of heavy isotopic standards to generate a calibration curve to allow for accurate quantitation of a modified peptide. The method may be used to accurately quantify C-terminal truncation in antibodies using mass spectrometry.

Abstract: The present invention generally pertains to methods of identifying sequence variants in a protein of interest. In particular, the present invention pertains to the use of heavy peptide standards with liquid chromatography-mass spectrometry analysis to specifically identify sequence variants of a protein of interest.

Abstract: The present invention generally pertains to methods of characterizing peptides or proteins of interest. In particular, the present invention pertains to the use of the nonionic surfactant DDM to improve recovery of hydrophobic peptides in pharmacokinetic, reduced peptide mapping, or other biotherapeutic protein analyses.

Abstract: Methods for characterizing host-cell proteins in a sample matrix are provided.

Abstract: The present disclosure belongs to a sterile preparation, subpackage and output system for serum and a method therefor. The system includes a blood collection and separation unit configured to collect venous blood and capable of achieving centrifugal separation of blood; a serum collection unit cooperating with the blood collection and separation unit and configured to achieve sterile collection of serum; a liquid subpackage unit cooperating with the serum collection unit and configured to achieve precise sterile subpackage of the serum; and a liquid boosting pen configured to achieve precise quantitative output of the serum. The system has the characteristics that the structure is simple, the overall process is simple and controllable, the safe and long-term storage of the serum is guaranteed, the waste of the serum and the blood drawing capacity are reduced, and the burden and negative emotion of a patient are relieved.

Abstract: The present invention generally pertains to methods of characterizing at least one protein of interest in a biological sample. In particular, the present invention pertains to the use of automated iterative tandem mass spectrometry (AIMS) to identify, quantify and characterize at least one protein of interest and/or biomarker from a biological sample such as plasma.

Abstract: The present invention generally pertains to methods of preventing disulfide scrambling in non-reducing liquid chromatography-mass spectrometry analysis of a protein of interest. In particular, the present invention pertains to the addition of cystamine to a non-reducing liquid chromatography-mass spectrometry analysis of an antibody to prevent disulfide scrambling.

Abstract: The present invention generally pertains to methods of detecting host cell proteins. In particular, the present invention pertains to the use of a novel activity-based protein profiling probe to identify host cell proteins with lipase activity in a pharmaceutical formulation.

Abstract: The present disclosure provides an improved method for accurately measuring the amino acid sequence of a therapeutic protein, in particular, an antibody, to insure the homogeneity of the protein such that it is suitable for administering to a human subject for treating a disease or disorder. The methods employ analytical physical chemistry techniques, in particular, a guided electron-transfer dissociation (ETD) and mass spectrometry (MS) approach for robust sequence coverage of the molecule with high accuracy and speed of use.

Abstract: The present disclosure provides an improved method for profiling the nature of undesirable host cell proteins (HCPs) in a therapeutic antibody preparation using an improved assay. The assay includes three (3) exemplary steps comprising: ultra-low trypsin digestion, long gradient liquid chromatography, and mass spectrometry (MS) using, in particular, BoxCar mass spectrometry. The disclosure allows for determining the purity of a therapeutic antibody such that it is suitable for use in patients.

Abstract: The present disclosure provides a method for measuring post-translational modifications in proteins such as antibodies. In particular, the method may be used to quantify C-terminal truncation in antibodies that incorporates heavy isotopic standards for both the unprocessed C-terminal K peptide and the truncated C-terminal K peptide to build a calibration curve and quantify this PTM using mass spectrometry. Quantification of post-translational modifications may occur in a single liquid chromatography tandem mass spectrometry (LC-MS2) run.

Abstract: The present disclosure provides a method for accurately measuring post-translational modifications in proteins such as antibodies. In particular, the method pertains to the use of heavy isotopic standards to generate a calibration curve to allow for accurate quantitation of a modified peptide. The method may be used to accurately quantify C-terminal truncation in antibodies using mass spectrometry.

Abstract: Methods for characterizing host-cell proteins in a sample matrix are provided.

Abstract: Migrating applications executing on a storage system, including: detecting, by the storage system, that an application executing on a first platform within the storage system should be migrated to a second platform within the storage system; rejecting, by the storage system, all pending input/output (‘I/O’) requests received by the storage system from the application executing on the first platform; and initiating, by the storage system, execution of the application on the second platform.

Abstract: Methods are provided herein for determining the likelihood that a subject, such as an asymptomatic subject, has chlamydial pelvic inflammatory disease. In some embodiments, the method can determine the likelihood that a pharmaceutical agent is effective for treating a subject that has chlamydial pelvic inflammatory disease. In other specific non-limiting examples, the method predicts endometritis and elevated pathogen burden. The subject is a female, such as a human female.

Abstract: Migrating applications executing on a storage system, including: detecting, by the storage system, that an application executing on a first platform within the storage system should be migrated to a second platform within the storage system; rejecting, by the storage system, all pending input/output (‘I/O’) requests received by the storage system from the application executing on the first platform; and initiating, by the storage system, execution of the application on the second platform.

Abstract: Migrating applications executing on a storage system, including: detecting, by the storage system, that an application executing on a first platform within the storage system should be migrated to a second platform within the storage system; rejecting, by the storage system, all pending input/output (‘I/O’) requests received by the storage system from the application executing on the first platform; and initiating, by the storage system, execution of the application on the second platform.

Abstract: Methods are provided herein for determining the likelihood that a subject, such as an asymptomatic subject, has chlamydial pelvic inflammatory disease. In some embodiments, the method can determine the likelihood that a pharmaceutical agent is effective for treating a subject that has chlamydial pelvic inflammatory disease. In other specific non-limiting examples, the method predicts endometritis and elevated pathogen burden. The subject is a female, such as a human female.