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Patent
CMC Biologics | Date: 2015-04-14

The present invention relates to a high cell density fermentation fill and draw process for producing a product in a bioreactor system wherein during the fermentation, medium comprising impurities is removed via the impurity filter unit while new fresh medium is added to the cell culture vessel to replenish consumed nutrients and expelled medium.


News Article | May 3, 2017
Site: www.eurekalert.org

ANN ARBOR, Mich. - The disease is characterized by inflammation and a buildup of tissue around the eyes that cause them to bulge painfully from their sockets. There has never been a safe and effective treatment for Graves' eye disease, also known as thyroid eye disease, for the one million Americans with the condition. Patients see inconsistent benefit from anti-inflammatory medicines and complex orbital surgery helps give some a more natural appearance once the disease has run its course. The results of a clinical trial led by the University of Michigan Kellogg Eye Center offers hope for those with moderate-to-severe active TED. Patients had a significant reduction in eye symptoms after treatment with teprotumumab, a study drug the U.S. Food and Administration called a "breakthrough therapy." Most study patients in the trial who got the active drug instead of a placebo had reduced eye bulging, eye pain and swelling and improved quality of life, the study's primary and secondary end points. For some, the therapeutic benefit was rapid, occurring within six weeks of intravenous infusions of the drug that blocks what researchers say is an autoimmune attack on muscles around the eyes. Published in the New England Journal of Medicine, the clinical trial data represents 25 years of research led by the lead study author the Kellogg Eye Center's Terry J. Smith, M.D., an endocrinologist and Frederick G.L. Huetwell Professor of Ophthalmology and Visual Sciences. TED is a rare condition associated with Graves' disease, an autoimmune disorder that causes an overproduction of thyroid hormone, or hyperthyroidism. Symptoms include swelling of the eyelids, constant stare, bulging eyes, eyelid retraction, optic neuropathy, double vision and other symptoms. Approximately 25 to 50 percent of those with Graves' disease will develop TED, most of them women. Previous findings in Smith's laboratory suggested that an insulin-like growth factor 1 receptor (IGF-1R) plays an important role in Graves' disease and other autoimmune diseases. "Specifically, we have found that there is an unusually high presence of IGF-1 receptors on cells surrounding the eye in TED," says Smith, who is widely recognized for his groundbreaking research on treatments for TED and related autoimmune disorders. Building on this discovery, an outgrowth of basic science research conducted at the University of California, Los Angeles, and then at the Kellogg Eye Center, Smith and study author Raymond Douglas, M.D., Ph.D., a Graves' eye disease specialist and renowned oculoplastics surgeon, initiated the study of thyroid-associated ophthalmopathy. "The eyes are particularly susceptible to Graves' disease because the autoimmune attack often targets the eye muscles and connective tissue surrounding the eye," Douglas says. "This occurs as a consequence of these tissues containing proteins that are shared with the thyroid gland." The study, lasting 24 weeks and involving 88 patients, was the largest multi-center Graves' eye disease trial. Patients were recruited between July 2, 2013 and Sept. 23, 2015, from 15 sites across the United States as well as Italy and Germany and the United Kingdom. Study investigators examined the benefit of teprotumumab, a monoclonal antibody shown to inhibit IGF-1 function and was originally developed as a cancer drug. Although teprotumumab failed to exhibit efficacy in patients with cancer, the team believed it might be useful in interrupting the TED disease process. At the end of the trial, 69 percent of study patients receiving infusions of teprotumumab once every three weeks had reduced eye bulging (proptosis) and increased quality of life compared to 20 percent in the placebo group. Patients were randomly assigned to receive either a placebo or an active drug. Neither participants nor researchers knew which medicine was being used so they could describe what happened in the trial without bias. Some participants had results after two injections at week six when, according to the study, a reported 43 percent of patients in the treatment group compared to 4 percent in the placebo group had a response. Patients who responded to the treatment reached the study's primary end point of a reduction by 2 points or more in the severity of the disease, which was measured on a 7-point Clinical Activity Score, and reduction by 2 mm or more in the degree of proptosis. Secondary end points included better quality of life. Those in the treatment group had a baseline Clinical Activity Score of 5.1. The marked reduction in proptosis is similar to the kind of results surgical patients would expect, authors note. "The findings have implications for other autoimmune diseases in which IGF-1 reception has already been implicated such as rheumatoid arthritis," Smith says. The most common side effect of treatment was nausea. Muscle spasms and diarrhea were also reported, particularly among patients with gastrointestinal disease. The only drug-related adverse event was hyperglycemia in patients with diabetes; these events were controlled by adjusting medication for diabetes. The results provide inroads for a new therapy to safely minimize the severity of the eye condition. "The study is one of two pivotal clinical trials needed to achieve registration of teprotumumab as the first approved therapy to prevent TED symptoms," says David Madden, president and chief executive officer of River Vision Corporation, which has entered an agreement to manufacture the drug with CMC Biologics in Copenhagen, Denmark. The drug cannot be prescribed currently for TED patients. A follow-up clinical trial is underway, but not recruiting participants, and is expected to be complete in 2018. River Vision sponsored the study and collaborated with academic researchers on the study design. Researchers received grants from the National Institutes of Health, Research to Prevent Blindness, the FDA's Office of Orphan Products Development, and others.


The present invention relates to a bioreactor arrangement for producing a biopolymer expressed by a cell and a continuous process for a capturing the biopolymer employing two chromatography units operated in series or independently.


Patent
CMC Biologics | Date: 2015-01-29

The present invention relates to a chromatography system (20) wherein the chromatography system comprises an eluting system (10) and a capturing system (11) consisting of at least two chromatography units (2,3) operated alone or in series and a capturing process employing in-line buffer dilution in, which concentrated buffers are blended with water and provided to the chromatography units.


Patent
CMC Biologics | Date: 2014-03-11

The invention provides expression vectors and host cells for high-level expression of recombinant proteins. The expression vectors comprise Chinese hamster ovary elongation factor 1- (CHEF1) transcriptional regulatory DNA elements and a cytomegalovirus (CMV) promoter and/or a human adenovirus tripartite leader (AdTPL) sequence. The invention achieves increased protein expression and better productivity of host cells compared to previously described expression systems.


Grant
Agency: European Commission | Branch: FP7 | Program: BSG-SME | Phase: SME-1 | Award Amount: 1.78M | Year: 2011

A group of European SMEs with expertise in process cleaning and cleaning validation as well as other environmental technologies addresses a major market opportunity in the supply of a Process Analytical Technology (PAT) compliant unit for online verification of Clean-in-Place (CIP) processes used in the pharmaceutical industry. CIP equipments provide Water for Injection (WFI) along with cleaning agents at predetermined temperatures and pressures for cleaning production equipments in pharmaceutical or food processing industry. To conform to high level cleaning regulations, preconfigured, longer than necessary cleaning cycles are followed wasting tremendous quantities of water and cleaning agents. Additional laboratory testing of residual samples from the vessels determines whether further cleaning is required or the production process can resume. This results in long periods of process downtime, while the laboratory results are awaited. PATOV is a project designed to significantly optimise these CIP processes by introducing an online, realtime cleaning validation system that will ensure optimal cleaning, but simultaneously control cleaning time and cleaning agents used. This will enable reduction in cleaning costs and process downtime while at the same time providing more analytical information to the client. The critical challenges in the project relate to the continuous sampling and the separation of the liquid component from the returned WFI so that it can be fed into commercially available analysers. Superiorly, the selection and adaptation of a new analytical technology based on infrared spectroscopy seems to be promising. The project is expected to have a severe potential to improve the efficiency and competitiveness of pharmaceutical and food processing industry with significant benefits on the quality of pharmaceutical and food products available to the public. At the same time PATOV will have direct environmental benefits by reducing water and energy consumption by optimizing cleaning cycle time.


Patent
CMC Biologics | Date: 2015-11-25

Materials and methods are provided which allowed for increased expression of a transfected gene of interest in a recombinant host cell.


Patent
CMC Biologics | Date: 2016-03-07

The invention provides expression vectors and host cells for high-level expression of recombinant proteins. The expression vectors comprise Chinese hamster ovary elongation factor 1- (CHEF1) transcriptional regulatory DNA elements and a cytomegalovirus (CMV) promoter and/or a human adenovirus tripartite leader (AdTPL) sequence. The invention achieves increased protein expression and better productivity of host cells compared to previously described expression systems.


Patent
CMC Biologics | Date: 2014-11-19

Provided is a bioreactor system and a fermentation process employing continuous inline medium dilution in which concentrated medium and nutrients are blended with water or buffer and fed to the cell culture vessel of a bioreactor system, e.g. for production of antibodies and other recombinant proteins by mammalian cells.


A method for improving productivity in microbial fermentations and mammalian cell culture bioreactors.

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