摘要:
Provided herein are solutions to improve peak integration for example chromatographic processes using a method which includes elements of artificial intelligence to process the integration of peaks in the chromatographic profiles, as generated from the analytical assays used in the quality testing of therapeutic products. The method of the present invention in chromatographic peak integrations develops a solution for enabling digitalization within the areas of real-time release testing, automated quality control, process analytical technologies, and continuous manufacturing.
摘要:
Systems disclosed herein provide for a disposal cabinet for discarding and identifying a variety of injection devices. Embodiments provide for the identification of the injection device based on at least one color and shape of the injection device. The identification of the injection device is performed with a plurality of decision trees. The injection devices are safely and efficiently discarded into a disposal container located within the disposal cabinet.
摘要:
The present invention relates to methods and compositions for modulating glycosylation of recombinant proteins expressed by mammalian host cells during the cell culture process. Also disclosed are methods of culturing a host cell expressing a recombinant protein in a cell culture medium comprising a disaccharide or a trisaccharide, while keeping the osmolality constant.
摘要:
The invention relates to the field of pharmaceutical formulations of follicle-stimulating hormone (FSH), luteinising hormone (LH), and mixtures of FSH and luteinising hormone (LH), and to methods of producing such formulations. The invention provides a liquid or freeze-dried formulation of FSH, or LH, or FSH and LH comprising a surfactant selected from Pluronic® F77, Pluronic F87, Pluronic F88 and Pluronic F68.
摘要:
The invention is in the field of cell culture. Particularly the invention relates to methods of culturing a host cell expressing a recombinant protein in a cell culture medium comprising an effective amount of 4,4′-diisothiocyanostilbene-2,2′-disulfonic acid (DIDS) or supplemented with an effective amount of DIDS, whereby production of said protein is increased relative to cells grown without DIDS.
摘要:
In various embodiments, the present invention provides methods, compositions, dosing, and administration schedules for treatment of autoimmune diseases, including systemic erythematosus (SLE), for example, comprising administering to a patient in need of such treatment a TACI-Ig fusion molecule such as atacicept. In one embodiment, the TACI-Ig fusion molecule is administered in amount sufficient to slow, suppress or inhibit proliferation-inducing functions of BLyS and APRIL, in particular the use of multiple administrations of the fusion molecule at relatively low dose over the course of the treatment.
摘要:
The present invention relates to a process for the production of interferon beta, and to an interferon beta composition having a unique glycosylation pattern.
摘要:
The invention relates to a multiple-variable dose method for treating a disorder in which TNF± activity is detrimental, comprising administering to a subject in need thereof a first induction dose of an anti-TNF± antibody which ranges from 161 to 320 mg such that a threshold level of TNF± inhibitor is achieved within an induction phase; and subsequently administering to the subject at least one treatment dose of the TNF± inhibitor within a treatment phase, such that treatment occurs
摘要:
The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, and at least one component selected from the group consisting of: a polyvinylpyrrolidone (PVP) surfactant, an inositol sugar stabiliser, and a gluconate salt toncifier. 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.