Abstract:
Pharmaceutical preparations containing hypersialylated immunoglobulins are described. The preparations are stable to shear stress. The pharmaceutical compositions described herein provide pharmaceutically acceptable hslgG compositions that are stable against shear stress (e.g., a significant a number of subvisible particles do not form when the formulation is subjected to shear stress, such as agitation, for example, durin shippin and thus can be shipped and handled in liquid form.
Abstract:
Fc-antigen binding constructs having a CTLA-4 binding domain and two or more Fc domains are described as are methods for using such constructs. Also described are polypeptides making up such constructs. Fc domain monomers that are included in the constructs can include amino acid substitutions that promote homodimerization or heterodimerization
Abstract:
Techniques and systems for determining a correct alignment of nucleic acid sequences are described. Determining the correct alignment may include generating multiple reference sequences that include one or more variants and aligning the nucleic acid sequences to the multiple reference sequences. The correct alignment may include performing an alignment of the nucleic acid sequences using the multiple reference sequences and determining the correct alignment for the nucleic acid sequences based at least in part on a result of the alignment using the multiple reference sequences.
Abstract:
Methods disclosed herein include an improved technique for comparing a glycosylation profile of a first protein (e.g., an innovator protein drug) with a glycosylation profile of a second protein (e.g., a corresponding biogeneric/biosimilar). For example, a method of manufacture can include providing or obtaining a batch of a test glycoprotein drug substance, using mass spectrometry to acquire a test oxonium ion profile from a sample of the test glycoprotein drug substance batch, comparing the test oxonium ion profile to a corresponding target oxonium ion profile of a target glycoprotein drug product, and processing the batch of the test glycoprotein drug substance as a drug product if the difference between the test oxonium ion profile and the corresponding target oxonium ion profile is tolerable, or taking an alternative action if the difference between the test oxonium ion profile and the target oxonium ion profile is not tolerable.
Abstract:
The present invention features methods of treating a subject having an autoimmune disease and/or inflammation including determining the genotype, and/or the glycophenotype of the subject and administering to the subject an Fc-activity modulating agent or an anti-TNFα agent based on the genotype and/or the glycophenotype of the subject. The invention also features methods of predicting the responsiveness of a patient to an anti-TNFα treatment by identifying a patient having inflammation or an autoimmune disease, determining the genotype, or glycophenotype of the subject, and selecting the patient for treatment with an Fc-activity modulating agent or an anti-TNFα agent based on the genotype and/or the glycophenotype of the subject.
Abstract:
Pharmaceutical preparations containing polypeptides having particular sialylation patterns, and methods for the treatment of immune-related thrombocytopenia with such preparations, are described.
Abstract:
Described herein are pharmaceutical compositions comprising a LMWH preparation having at least one chain having a glycol split uronic acid residue (UG) in the preparation and uses thereof.
Abstract:
Polypeptide preparations having target levels of glycans, and methods of producing such polypeptide preparations using copper, are described.