The invention encompasses formulations and methods for the production thereof that permit the delivery of concentrated protein solutions. The inventive methods can yield a lower viscosity liquid protein formulation or a higher concentration of therapeutic or nontherapeutic proteins in the liquid formulation, as compared to traditional protein solutions. The inventive methods can also yield a higher stability of a liquid protein formulation.

The present invention relates to novel antibody frameworks with advantageous properties.

There is described herein, a method for inducing Tc22 lineage T cells from a population of CD8+ T cells, the method comprising: a) providing a population of CD8+ T cells; b) activating the population; and c) culturing or contacting the population of CD8+ T cells with Coenzyme A.

In some embodiments, the invention provides a method for identifying an agent beneficial to treat a patient with inflammatory bowel disease comprising: a) determining a status of an intestinal barrier in the patient; and b) categorizing the status as severe dysfunction or moderate dysfunction, wherein a patient categorized as having severe dysfunction is identified as a patient who will benefit from treatment with an agent selected from the group consisting of an anti-TNF agent and/or an anti-IL-12/23 agent, and a patient categorized as having moderate dysfunction is identified as a patient who will benefit from treatment with an anti-integrin agent, an anti-janus kinase agent, and/or and a sphingosine-1-phosphate receptor agonist agent.

The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, arginine and/or methionine, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.

The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, EDTA, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.

A pharmaceutical composition for improving insulin sensitivity in diseases accompanied by impaired glucose tolerance is disclosed. The pharmaceutical composition contains an antibody or an antigen-binding fragment thereof that specifically recognizes ITIH1 exhibiting increased expression in diseases accompanying high blood sugar. The pharmaceutical composition can be effectively used for improving insulin sensitivity in various diseases accompanying high blood sugar.

The present disclosure provides a therapy for diabetes that targets abnormal stem cells in combination with stem cell migration. In one embodiment, the present disclosure provides a therapy for diabetes and/or diabetes-related diseases and disorders and/or symptoms that targets abnormal stem cells in combination with stem cell migration. In one embodiment, the present disclosure provides diagnosis of diabetes and/or diabetes-related diseases and disorders and/or symptoms, or the risk thereof, using abnormal stem cell migration and/or residence as an indicator.

Disclosed herein are formulations with improved stability or reduced viscosity that comprise a therapeutic protein and a lyo-enhancing excipient, wherein the improved stability formulation is characterized by improved stability in comparison to a control formulation otherwise identical to the stability-enhanced formulation but lacking the lyo-enhancing excipient, and the reduced viscosity formulation is characterized by reduced viscosity in comparison to a control formulation otherwise identical to the reduced viscosity formulation but lacking the lyo-enhancing excipient. Further disclosed herein are methods of improving stability of therapeutic formulations, reducing viscosity of therapeutic formulations, or improving parameters of lyophilization processes.

Provided herein, in some embodiments, are artificial secretion peptides capable of directing secretion from Lactobacillus for use, for example, in producing heterologous proteins, including therapeutic proteins.