R.P. Scherer Technologies, LLC

Disclosed herein is a softgel capsule including a fill material, shell composition and a coating having an enteric polymer, wherein the coating provides about 1% to about 10% weight gain of the capsule. The coating improves the robustness of enteric property and minimized the moisture absorption during dissolution of the softgel capsule.

Disclosed in certain embodiments is a delayed release softgel capsules comprise a fill material that is encapsulated in a pH dependent shell composition, the pH dependent shell composition including pectin and gellan gum. Also disclosed are methods of preparing any of the delayed release softgel capsules described herein and methods of use thereof.

Disclosed in certain embodiments is a delayed release softgel capsules comprise a fill material that is encapsulated in a pH dependent shell composition, the pH dependent shell composition including pectin and gellan gum. Also disclosed are methods of preparing any of the delayed release softgel capsules described herein and methods of use thereof.

The present disclosure is directed to a pharmaceutical formulation intended for oral delivery of synthetic or natural poorly permeable calcitonin gene-related peptide (CGRP) inhibitors or salts/solvates thereof having a therapeutic activity. The pharmaceutical formulation can include a synthetic or natural poorly permeable CGRP inhibitors or salt or solvate thereof in an amount 0.01-10 wt. % of the total weight of the formulation; a lipophilic phase comprising triglycerides of fatty acids in an amount of 50-80 wt. % of the total weight of the formulation; and at least one lipophilic surfactant comprising partial esters of polyol and fatty acids in an amount of about 10-50 wt. % of the total weight of the formulation.

Embodiments of the present disclosure include systems and methods for confidentially producing shipment orders for clinical trials. The method includes receiving a plurality of supply orders associated with one or more clinical trials and determining a clinical trial study, a site location, and a treatment type. A first plurality of supply orders are assigned to a packaging site based on the site location. The method further includes, associating a first sub-group of the first plurality of supply orders with a first assembly procedure, associating a second sub-group of the plurality of supply orders with a second assembly procedure, and assigning, randomly, the plurality of kit identifiers to the first sub-group and the second subgroup, thereby creating a plurality of blinded kits. The method further includes confidentially producing shipment orders for the first plurality of clinical trials based on the plurality of blinded kits.

The present disclosure provides antibodies specific for glypican-3 (GPC3). Nucleic acids that encode one or both of the variable chain polypeptides of an antibody of the present disclosure are also provided, as are cells that include such nucleic acids. Also provided are compositions that include the antibodies of the present disclosure, including in some instances, pharmaceutical compositions. Methods of making and using the antibodies of the present disclosure are also provided. In certain aspects, provided are methods that include administering to an individual having a cell proliferative disorder a therapeutically effective amount of an antibody of the present disclosure, where the antibody is administered to the individual to enhance an immune response, e.g., a T cell response, to abnormally proliferating cells of the cell proliferative disorder. The antibodies are useful in various diagnostic, and monitoring applications, which are also provided.

The invention provides a method of producing a population of CD34 + hematopoietic precursor cells. The CD34 + hematopoietic precursor cells are used in methods of producing natural killer (NK), methods of inducing NK cell differentiation from pluripotent stem cells (PSCs), and methods of generating terminally differentiated hematopoietic cells from PSCs. The differentiation of immune cells such as NK cells from PSCs includes the use of a hemogenic endothelium induction cocktail that includes a WNT signaling pathway activator, a bone morphogenetic protein and/or a vascular endothelial growth factor. Also provided is a method of producing hematopoietic stem cells from pluripotent stem cells.

The present disclosure provides thiazolidine (Tz) linkers for protein-drug conjugates. In addition, the disclosure also encompasses compounds useful for producing such protein-drug conjugates, as well as methods for production of such protein-drug conjugates. The disclosure also encompasses methods of using the protein-drug conjugates for the treatment of a disease or disorder in a subject.

Disclosed herein are dosage forms comprise a solid or a semisolid lipid with immediate release properties and/or with extended release properties. The dosage forms disclosed herein may have their active pharmaceutical ingredient's (API's) release profile stabilized via curing and/or via the addition of a surfactant with an HLB value of less than 10.

A pharmaceutical dosage form comprises a capsule shell and a fill composition, wherein the fill composition comprises an emulsion of (a) simethicone, (b) loperamide or a pharmaceutically acceptable salt thereof, and (c) at least two surfactants, wherein the emulsion has a hydrophilic lipophilic balance ranging from about 8 to about 12. Also described are methods of making the pharmaceutical dosage forms and methods for treating humans suffering from gastrointestinal distress.