14 results about "Biotherapeutic agent" patented technology

A device can include a capsule containing an array of microneedles and a mechanical actuator. The device can be in an ingestible form for delivery to a duodenum or other target location within a subject and can release a first shell portion and a second shell portion of the capsule from one another in response to stimuli or conditions in or en route to the duodenum or other target location. The launcher can drive the released first shell portion and the second shell portion away from one another to expose the array of microneedles in a position for achieving penetrating engagement with a lining of the duodenum or other target location. The penetrating engagement can facilitate delivery of a biotherapeutic agent or other payload via the microneedles.

Described herein are therapeutic pH-responsive micelle compositions comprising block copolymers and biological therapeutic agents useful in the treatment of cancer, methods for making such micelles, and intermediate compositions useful for making such micelles.

Formulations containing pH-sensitive nanoparticles for the enteric delivery of therapeutic agents are provided. The nanoparticles include a pH-sensitive polymer that protects the therapeutic agent against degradation in the stomach and allows it to be released in the small intestine or colon. The nanoparticle formulation is particularly effective at protecting sensitive biotherapeutic agents from degradation when administered orally, and makes it possible to avoid administration of such agents by injection. Also provided are methods for producing the formulations, as well as methods of treating diseases employing the formulations.

The present invention relates to the viscosity reduction and stability enhancement of biotherapeutics in biomanufacturing and formulation. The method of viscosity reduction and stability enhancement comprises combining a biotherapeutic with a performance-enhancing excipient chosen from bis acetyl arginine, bis acetyl lysine, bis acetyl histidine, bis acetyl serine, bis acetyl proline, bis acetyl tryptophan, propionyl arginine, propionyl lysine, propionyl histidine, propionyl serine, propionyl proline, propionyl tryptophan, and mixtures thereof.

The invention relates to a method, expression system and related kit for producing at least one biologically active molecule, in particular a biotherapeutic, by optogenetic control of gene expression in at least one eukaryotic or prokaryotic cell, wherein the biologically active molecule comprises at least one protein of interest comprising at least two different subunits. In particular, one embodiment of the expression system according to the invention comprises three expression cassettes (2, 3, 4) for optogenetic control of the production of a protein of interest comprising two subunits (5, 6). A first expression cassette (2) comprises a first nucleic acid sequence (7) that is operably linked to a first promoter (8) and encodes a photosensitive transcription factor (9) comprising a gene expression controlling domain (10). The expression system (1) further comprises a second expression cassette (3) comprising a second nucleic acid sequence (11) encoding the first subunit (5) of the protein of interest. The second nucleic acid sequence (11) is operably linked to a second promoter (12) being operably linked to a transcription factor binding site (13) designed to bind the photosensitive transcription factor (9). The expression system (1) also comprises a third expression cassette (4) comprising a third nucleic acid sequence (15) encoding the second subunit (6) of the protein of interest and being operably linked to a third promoter (16).

Described herein is an annular intravaginal device including a hydrogel matrix, the hydrogel matrix including a live biotherapeutic agent and a nutrient source for the live biotherapeutic agent, wherein the hydrogel matrix includes a hydrogel-forming polymer crosslinked with a divalent or trivalent cation. Also described is a method of making the annular intravaginal device. The annular intravaginal device is particularly useful in promoting a healthy vaginal microbiome when inserted into the vagina of a woman in need of such treatment as well as to treat infections and disease.

A method for producing replicating DNA molecules is described, producing DNA products, such as vaccines or biotherapeutics. A parental DNA template comprises a sequence of interest, and a modified Col E1 origin lacking RNA I inhibition, having an inducible switch for recombinase translation control. The method permits control of plasmid DNA production during host fermentation by controlling relocation of a plasmid RNA II promoter to upstream of the RNA II primer template sequence through recombination, where RNA II initiates plasmid replication. The bacterial origin of a linearized plasmid is stably inserted into the host chromosome by separating the origin's promoter from the RNA II primer template sequence, allowing antibiotic-free fermentation while the plasmid is hidden within the chromosome. The excision of the targeted plasmid DNA is induced to control recombination, forming a plasmid with a functional bacterial origin lacking negative regulation, driving run-away amplification and high plasmid DNA production.

Systems, methods, and materials are described for making solid unit dosage forms for administration of therapeutic and biotherapeutic agents, particularly dosage forms for various enteral, nasal, pulmonary, vaginal, topical, and other suitable non-injection delivery routes. Contact freezing methods may be used in conjunction with lyophilization or vacuum drying to process a liquid formulation and produce solid unit dosage forms having a high degree of structural stability while preserving the therapeutic activity of the included agents.

This invention discloses a method for specifically recognizing antigen epitopes. 16 AQTGYAPV 23 This invention relates to a monoclonal antibody D3-mAb against porcine rotavirus and its applications, belonging to the field of antibody bioengineering technology. The monoclonal antibody D3-mAb specifically binds to the VP8 protein of porcine rotavirus and exhibits neutralizing activity; its amino acid sequence is shown in SEQ ID NO. 8. This invention screened a monoclonal antibody D3 with neutralizing activity against the VP8 protein, and subsequently identified the neutralizing antigenic epitope. 16 AQTGYAPV 23 Recognized by D3-mAb, sequence comparison analysis of currently circulating PoRVA strains revealed that this antigenic epitope is absolutely conserved. Furthermore... 16 AQTGYAPV 23 The epitope, located on the surface of the VP8 protein, interacts with the antibody's variable region via six hydrogen bonds. This invention provides a novel approach for designing novel epitope vaccines and antiviral strategies, and the provided monoclonal antibody holds promise for development into a biotherapeutic agent and diagnostic agent for porcine rotavirus infection.

The present invention provides for a fully integrated microfluidic system capable of producing single-dose amounts of biotherapeutics at the point-of-care wherein protein production, purification and product harvest are all integrated as a single microfluidic device which is portable and capable of continuous-flow production of biotherapeutics at the microscale using a cell-free reaction system.

Provided herein are methods of predicting a likelihood that a subject will develop ileitis, intestinal fibrosis or colitis based on an amount of acetate or acetate-producing bacteria detected in a sample obtained from a subject. Certain genetic risk variants at TNF super-family member 15 (TNFSF15) may also be detected. Methods, systems and kits for treatment of develop ileitis, intestinal fibrosis or colitis are also provided, which include inhibitors of acetate or acetate-producing bacteria, or targeting biologic therapeutics, such as inhibitors of Tumor necrosis factor (TNF)-like cytokine 1A (TL1A).

The present disclosure generally relates to methods of identifying and / or selecting self-replicating RNA (srRNA) delivery systems suitable for biomedical applications. More particularly, the present disclosure relates to methods of identifying and / or selecting srRNA delivery systems using a combination of key quality attributes of srRNA vaccines and biotherapeutics. Also provided are srRNA compositions, formulations obtained by the methods of the present disclosure, as well as methods for inducing pharmacodynamic effects in a subject in need thereof, and methods for preventing and / or treating various health conditions.