Top Selling Monoclonal Antibodies 2014
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Enumeral Biomedical: An Undiscovered And Undervalued Biotechnology Company

Enumeral Biomedical: An Undiscovered And Undervalued Biotechnology Company | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Enumeral Biomedical (OTCQB:ENUM) is a biotechnology company focused on discovering and developing novel immunotherapies for the treatment of cancer and autoimmune diseases.
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http://www.enumeral.com/r-and-d/r-and-d-overview.php

 

Enumeral is enabling and accelerating the discovery and development of novel antibody immunotherapies, or immunomodulators, which are validated with our human-driven immune profiling platform. The core technology behind our platform was developed at and licensed from the Massachusetts Institute of Technology, Harvard University, Whitehead Institute for Biomedical Research and Massachusetts General Hospital.

 

Our antibodies are rapidly generated directly from the platform using proprietary cellular libraries derived from target-specific immunized sources or from human patient donors.

 

We perform sensitive measurements on single immune cells using our proprietary technology in order to mine the immune system’s rich collection of cells for information that is difficult to obtain using other methods and that may guide the development of effective therapeutics and diagnostics. The efficiency and sensitivity provided through our platform increases the probability of finding rare antibody-secreting cells associated with disease or drug response, as well as rare and previously unknown antibodies that may have the characteristics essential to becoming safe and effective drugs.

Studying rare immune cells obtained directly from human patients for their functional responses can potentially lead to selection of best-in-class antibody drug candidates that may have a higher likelihood of successful development. Such knowledge generated from our platform is also being applied to better understand which drug candidates might work in which patients, and, at what stage of disease.

 

Our current antibody discovery and development programs target the checkpoint proteins PD-1, OX40 and Lag3.

 

Enumeral’s immunoprofiling platform harnesses The Power of Human™.

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Top Selling Monoclonal Antibodies 2014
Top Selling Monoclonal Antibodies 2014
Abstract A review of the best selling monoclonal antibodies in 2014 and 2013 is provided. Humira with sales of over $12.7 billion ($9.3 bn in 2012, $11bn 2013) remains the best selling monoclonal antibody, biologic as well prescription drug brand in 2014 and since 2012. The ranks of the next 4 top selling mabs remained unchanged from the 2012-2013 Table.  Remicade (9.8 Bn), Rituxan (7.6 Bn) , Avastin (7.0 Bn) and Herceptin (6.8 Bn)  were the second, third, fourth and fifth top selling mabs in 2014. The actual sales for 2014 as reported by the companies are provided. The total sales of the top selling blockbuster mabs listed in the Table were $68 billion in 2014. The global sales of all the approved therapeutic monoclonal antibodies were $78 billion in 2014. Besides the top 5 mabs, there was two monoclonal antibody with sales of over $3 billions, three with sales over $ 2 billion and 6 with sales of over $ 1 billion in 2014. In addition 5 recently launched mabs were nearing to reach sales of $ 1 billion this year. Currently 36 monoclonal antibodies are marketed in the US and Europe (January 2015).  FDA approved 6 new monoclonal antibodies in 2014. Alexion Soliris was the most expansive marketed monoclonal antibody with a price tag of $440,000 per year of treatment, a sort of Rolls-Royce of mabs and had sales of $2.2 billion in 2014.
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Best Selling Blockbuster Monoclonal Antibodies 2017

Best Selling Blockbuster Monoclonal Antibodies 2017 | Top Selling Monoclonal Antibodies 2014 | Scoop.it

 

Abstract

 

A review of the best selling monoclonal antibodies in 2017 and previous years is provided. Humira with sales of over $19 billion ($9.3 bn in 2012, $14.5 bn in 2015 and $16 bn in 2016) remains the best selling monoclonal antibody, biologic as well the prescription drug brand in 2017. Humira has remained the top selling global brand since 2012. The ranks of the next 4 top selling mabs changed rankings from the 2012-2016 Table due to competition from biosimilars.  Rituxan (9.2 Bn) , Herceptin (7.4 Bn), Remicade (7.1 Bn) and Avastin (7.1 Bn) and were the second, third, fourth and fifth top selling mabs in 2017. The actual sales for 2017 as reported by the companies are provided. 



The global pharma biotech market for prescription medicinal brands was over $1 trillion dollar in 2017. Biologics accounted for $220 billion and  mabs for $95 billion

 

The total sales of the top selling blockbuster mabs listed in the Table were $95 billion in 2017.  Besides the top 5 mabs with sales over $7 billion, there were two monoclonal antibody with sales of over $4 billions, four with sales over $3 billion, five with sales over $ 2 billion and 3 with sales of over $ 1 billion in 2015. There were 19 blockbuster mabs in 2019. At least 5 new recently launched mabs are likely to cross sales of $ 1 billion in 2018.

 

Currently 73 monoclonal antibodies are marketed in the US and Europe (Dec. 2017).  FDA approved 6 new monoclonal antibodies in 2014, 9 in 2015, 9 in 2016 and 9 in 2017. The FDA has already approved 4 new mabs in 2018 and EMA CHMP has recommended 2 new mabs in the 1Q2018.

 

The FDA has approved only 9 biosimilar so far while EMA/CHMP has cleared 28 biosimilar so far.

 

Alexion Soliris was the most expansive marketed monoclonal antibody with a price tag of $440,000 per year of treatment, a sort of Rolls-Royce of mabs and had sales of $2.6 billion in 2017.

 

The full report is not for public release or for request by email

 

 

 

 

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The full report is not available for public release or for request by email

 

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Routine measurements of factor VIII activity and inhibitor titer in the presence of emicizumab utilizing anti‐idiotype monoclonal antibodies - Nogami - 2018 - Journal of Thrombosis and Haemostasis ...

Routine measurements of factor VIII activity and inhibitor titer in the presence of emicizumab utilizing anti‐idiotype monoclonal antibodies - Nogami - 2018 - Journal of Thrombosis and Haemostasis ... | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Essentials Emicizumab (Emi) affects the APTT‐based assays of factor (F)VIII activity and inhibitor titer. A mixture of two anti‐Emi monoclonal antibodies (mAb) effectively neutralized the Emi activity. Anti‐Emi mAbs completely eliminated the influence of Emi on FVIII activity and inhibitor titer. The inclusion of anti‐Emi mAbs in routine FVIII assays would be useful for Emi‐treated patients. Summary Background Emicizumab is an anti‐factor (F)IXa/X bispecific monoclonal antibody (mAb), mimicking the factor (F)VIIIa cofactor activity. Emicizumab does not require activation by thrombin and its shortening effect on the activated partial prothrombin time (APTT) is more pronounced than that of factor (F)VIII. APTT‐based FVIII activity (FVIII:C) and FVIII inhibiter titer measurements are influenced by the presence of emicizumab. Aim To establish a reliable APTT‐based assay to measure FVIII in the presence of emicizumab. Methods Plasmas from hemophilia A (HA) patients without or with inhibitors were studied using one‐stage FVIII:C and Bethesda inhibitor assays. Two recombinant anti‐idiotype mAbs to emicizumab (anti‐emicizumab mAbs) were prepared, rcAQ8 to anti‐FIXa‐Fab and rcAJ540 to anti‐FX‐Fab. Results The combined anti‐idiotype mAbs (2000 nm each) eliminated the effects of emicizumab on APTTs of HA plasmas without or with inhibitor by competitive inhibition of antibody binding to FIX(a)/FX(a). Measurements of FVIII coagulation activity in HA plasmas without inhibitor were overestimated in the presence of emicizumab (1 μm = ~150 μg mL−1) at all reference levels of FVIII. The addition of anti‐emicizumab mAbs to the assay mixtures completely neutralized the emicizumab and facilitated accurate determination of FVIII:C. Anti‐FVIII inhibitor titers were undetectable in the presence of emicizumab in HA plasmas with inhibitor or normal plasmas mixed with anti‐FVIII neutralizing antibodies. These effects of emicizumab were completely counteracted by the addition of the anti‐idiotype mAbs, allowing accurate assessment of inhibitor titers. Conclusion The in vitro inclusion of anti‐emicizumab mAbs in the standard one‐stage coagulation assays prevented interference by emicizumab and enabled accurate measurements of FVIII:C and inhibitor titers.
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Antibody-Coupled T-cell Receptor (ACTR) Technology | Unum Therapeutic

Antibody-Coupled T-cell Receptor (ACTR) Technology | Unum Therapeutic | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Unum is being built to develop a universal cellular immunotherapy for cancer.

 

Our proprietary Antibody-Coupled T cell Receptor (ACTR, pronounced ‘actor’) is a chimeric protein that binds to tumor-targeting antibodies. When ACTR T cells are put into a patient, they can be targeted to attack tumors by co-administering cancer-specific antibodies. ACTR is a single construct that we believe may be used in combination with a wide variety of separately administered tumor-targeting antibodies to pursue different antigens and tumor types. Our approach leverages existing antibodies to mobilize a cytotoxic cellular response to attack antibody-labeled cancer cells. ACTR was initially invented in the laboratories of our scientific founder, Dr. Dario Campana.

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Anti-CD20 monoclonal antibodies: reviewing a revolution: Human Vaccines & Immunotherapeutics: Vol 0, No ja

Anti-CD20 monoclonal antibodies: reviewing a revolution: Human Vaccines & Immunotherapeutics: Vol 0, No ja | Top Selling Monoclonal Antibodies 2014 | Scoop.it
ABSTRACT
Since the inception of rituximab in the 1990s, anti-CD20 monoclonal antibodies have revolutionised the treatmant of B cell hematological malignancies and have become a cornerstone of modern gold-standard practice. Additionally, the potent efficacy of these agents in depleting the B cell compartment has been used in the management of a broad array of autoimmune diseases. Multiple iterations of these agents have been investigated and are routinely used in clinical practice. In this review, we will discuss the physiology of CD20 and its attractiveness as a therapeutic target, as well as the pharmacology, pre-clinical and clinical data for the major anti-CD20 monoclonal antibodies: rituximab, obinutuzumab and ofatumumab.
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MedImmune - AstraZeneca

MedImmune - AstraZeneca | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Introducing MedImmune, the worldwide biologics research and development arm of AstraZeneca, pioneering innovative research across key therapeutic areas.
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FDA approves Poteligeo (mogamulizumab-kpkc, Kyowa Kirin) for two rare types of non-Hodgkin lymphoma

FDA approves Poteligeo (mogamulizumab-kpkc, Kyowa Kirin) for two rare types of non-Hodgkin lymphoma | Top Selling Monoclonal Antibodies 2014 | Scoop.it

The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS.

 

Non-Hodgkin lymphoma is a cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system. MF and SS are types of non-Hodgkin lymphoma in which lymphocytes become cancerous and affect the skin. MF accounts for about half of all lymphomas arising from the skin. It causes itchy red rashes and skin lesions and can spread to other parts of the body. SS is a rare form of skin lymphoma that affects the blood and lymph nodes.

 

The approval was based on a clinical trial of 372 patients with relapsed MF or SS who received either Poteligeo or a type of chemotherapy called vorinostat. Progression-free survival (the amount of time a patient stays alive without the cancer growing) was longer for patients taking Poteligeo (median 7.6 months) compared to patients taking vorinostat (median 3.1 months).

The most common side effects of treatment with Poteligeo included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain and upper respiratory tract infection.

Serious warnings of treatment with Poteligeo include the risk of dermatologic toxicity, infusion reactions, infections, autoimmune problems (a condition where the immune cells in the body attack other cells or organs in the body), and complications of stem cell transplantation that uses donor stem cells (allogeneic) after treatment with the drug.

 

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Poteligeo is a monoclonal antibody that binds to a protein (called CC chemokine receptor type 4 or CCR4) found on some cancer cells.

The FDA granted this application Priority Review and Breakthrough Therapydesignation. Poteligeo also received Orphan Drug designation,

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Poteligeo is a monoclonal antibody that binds to a protein (called CC chemokine receptor type 4 or CCR4) found on some cancer cells. 

The FDA granted this application Priority Review and Breakthrough Therapydesignation. Poteligeo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

 

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Anti-interleukin 13 for asthma: stick or twist?

Anti-interleukin 13 for asthma: stick or twist? | Top Selling Monoclonal Antibodies 2014 | Scoop.it
CORRESPONDENCE|ONLINE FIRST Anti-interleukin 13 for asthma: stick or twist? Published:August 02, 2018DOI:https://doi.org/10.1016/S2213-2600(18)30275-3 Linked Article The results of the STRATOS trials1 of the anti-interleukin 13 monoclonal antibody tralokinumab for severe asthma might at first sight seem disappointing. The trials showed variable effects of tralokinumab on asthma exacerbations and FEV1 in patients with raised fractional exhaled nitric oxide (FENO), whereas Asthma Control Questionnaire-6 scores were significantly reduced by tralokinumab treatment in both studies, albeit less than the minimal important difference. Perhaps we should think outside of the box and take clues from other therapeutic areas. Benralizumab effectively blocks interleukin 5 for the treatment of severe eosinophilic asthma; however, some individuals have only a partial response and still have a persistent disease burden,2,  3 perhaps inferring that also blocking the unopposed effects of interleukin 13 might have a potential benefit. In this regard, as shown by the MESOS study,4 tralokinumab decreases FENO and IgE—but not blood eosinophils—in patients with moderate-to-severe asthma. We therefore propose that a combined approach, blocking interleukin 5 with benralizumab and interleukin 13 with tralokinumab, might be required to comprehensively suppress type 2 inflammation and achieve better outcomes (figure 1). This combined regimen could perhaps be considered akin to using co-trimoxazole for infection, or valsartan and sacubitril for heart failure. The patients who would benefit most from this combined treatment would be those with high eosinophils and FENO, although individual biomarker thresholds might be lower; for example, a combination of FENO >25 ppb and >150 eosinophils per μl, which occurs in approximately 40% of patients, might identify optimal responders to benralizumab and tralokinumab, as was previously seen with dupilumab.5 We believe that studies comparing combined benralizumab and tralokinumab with benralizumab alone are warranted to assess whether this strategy (albeit expensive) translates into improved outcomes in terms of control in severe eosinophilic asthma. It is perhaps surprising that the MESOS study4 showed no significant effect on bronchial and sputum eosinophil counts after neutralisation of interleukin 13 with tralokinumab, given that interleukin 13 is involved in the migration of eosinophils from blood vessels into tissues, regulated by interleukin 5 and eotaxin.6 Indeed, a putative trafficking effect of interleukin 13 would be consistent with the 17% increase (p=0·055) in blood eosinophils observed with tralokinumab.4 We postulate that blockade of interleukin 13 alone, in the presence of unopposed interleukin 4 signalling, is ineffective at arresting tissue eosinophil migration (figure 2). Notably, patients with eosinophilic oesophagitis showed a 92% reduction in epithelial eosinophils in response to dupilumab,7 which blocks signalling of both interleukin 4 and interleukin 13. We therefore await the results of the EXPEDITION study of dupilumab (NCT02573233) in patients with persistent asthma, in whom we would expect to see similar reductions in submucosal eosinophils from bronchial biopsy. In patients with severe persistent asthma, the use of dupilumab was associated with 48% fewer exacerbations despite a transient increase in blood eosinophils,5 in turn suggesting that airway eosinophils might have been reduced, although tissue eosinophils were not directly measured. Thus, we propose that blockade of both interleukin 4 and interleukin 13 is required to regulate eosinophil tissue trafficking in patients with asthma. Studies might therefore be indicated to directly compare the clinical efficacy of combined blockade with interleukin4 and interleukin 13 versus interleukin 5 and interleukin 13 in severe eosinophilic asthma. There is also the prospect of blocking thymic stromal lymphopoietin higher up the type 2 pathway with tezepelumab, which reduces FENO, IgE, and eosinophils. BL reports grants and personal fees from AstraZeneca and Sanofi, personal fees and other from Teva, personal fees from Novartis and Genentech, grants from Roche, and other from GlaxoSmithKline in relation to the submitted work; grants and personal fees from Meda, Boehringer Ingelheim, and Chiesi, grants from Janssen, personal fees from Lupin, Cipla, and Dr. Reddy's Laboratories, and Circassia, and consulting for Sandoz and Circassia outside of the submitted work; and his son is employee of Boehringer Ingelheim. SJ reports personal fees and non-financial support from Chiesi, Pfizer, and AstraZeneca, non-financial support from Teva, Meda, and Napp, personal fees from Boehringer Ingelheim, and travel fees from Napp outside of the submitted work. CRK reports personal fees and non-financial support from Pfizer outside of the submitted work. References Panettieri, RASjöbring, UPéterffy, A et al. Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials. Lancet Respir Med. 2018; 6: 511-525 FitzGerald, JMBleecker, ERNair, P et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016; 388: 2128-2141 Bleecker, ERFitzGerald, JMChanez, P et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016; 388: 2115-2127 Russell, RJChachi, LFitzGerald, JM et al. Effect of tralokinumab, an interleukin-13 neutralising monoclonal antibody, on eosinophilic airway inflammation in uncontrolled moderate-to-severe asthma (MESOS): a multicentre, double-blind, randomised, placebo-controlled phase 2 trial. Lancet Respir Med. 2018; 6: 499-510 Castro, MCorren, JPavord, ID et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018; 378: 2486-2496 Pope, SMBrandt, EBMishra, A et al. IL-13 induces eosinophil recruitment into the lung by an IL-5- and eotaxin-dependent mechanism. J Allergy Clin Immunol. 2001; 108: 594-601 Hirano I, Dellon ES, Hamilton JD, et al. Dupilumab efficacy and safety in adult patients with active eosinophilic esophagitis: a randomized double-blind placebo-controlled phase 2 trial. World Congress of Gastroenterology at ACG2017; Orlando, FL; Oct 13–18, 2017. Abstract 20. Article Info Publication History Published: August 02, 2018 IDENTIFICATION DOI: 10.1016/S2213-2600(18)30275-3 Copyright © 2018 Elsevier Ltd. All rights reserved. ScienceDirect Access this article on ScienceDirect
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Isatuximab: a ‘next-generation monoclonal antibody’

Isatuximab: a ‘next-generation monoclonal antibody’ | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Speaking from the 23rd Congress of the European Hematology Association (EHA) 2018, held in Stockholm, Sweden, Paul Richardson, MD, of the Dana-Farber Cancer Institute, Boston, MA, tells us about isatuximab, a revolutionary new antibody that has already been making waves in the multiple myeloma...
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Monoclonal Antibodies—An allergist perspective on the new biologics

Monoclonal Antibodies—An allergist perspective on the new biologics | Top Selling Monoclonal Antibodies 2014 | Scoop.it
The latest rage in treatment for allergic disease is a class of biologic drugs called monoclonal antibodies. They are miracle drugs for those who have trouble controlling asthma and eczema. They are also very expensive.
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Shaving Is an Epiphenomenon of Type I and II Anti-CD20–Mediated Phagocytosis, whereas Antigenic Modulation Limits Type I Monoclonal Antibody Efficacy

Shaving Is an Epiphenomenon of Type I and II Anti-CD20–Mediated Phagocytosis, whereas Antigenic Modulation Limits Type I Monoclonal Antibody Efficacy | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Rituximab is an anti-CD20 mAb used in the treatment of B cell malignancies. Loss of surface CD20 Ag from the surface of target cells is thought to be one mechanism governing resistance to rituximab, but how this occurs is not completely understood.
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Roche - Bispecific Antibodies

Roche - Bispecific Antibodies | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Bispecific Antibodies Bispecific Antibodies combine two or more antigen-recognizing elements into a single construct, able to bind to two or more targets. This accounts for the fact that more than one pathway is often at the root of the disease. One approach implies engineering multiple antigen binding domains into a single molecule. At Roche, we also have designed a new format for bispecific antibodies, called CrossMAbs (where MAb stands for Monoclonal Antibody). In contrast to other technologies the CrossMAb allows production and correct chain assembly using a standard process applied for the production of therapeutic antibodies. In December 2014, we announced the acquisition of Dutalys to strengthen our capabilities in the discovery and development of fully human, bi-specific antibodies based on their proprietary DutaMabs™ technology. The DutaMab™ technology platform further enables the development of bi-specific antibodies on a single arm of the antibody that are characterized by a high affinity and simultaneous binding against both targets, excellent stability and good manufacturing properties. Tags: Biotechnology
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Safety and tolerability of tildrakizumab, an anti–interleukin-23p19 monoclonal antibody, in patients with chronic plaque psoriasis over two years of treatment: Results from long-term extensions of ...

Safety and tolerability of tildrakizumab, an anti–interleukin-23p19 monoclonal antibody, in patients with chronic plaque psoriasis over two years of treatment: Results from long-term extensions of ... | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Background: We evaluated tildrakizumab (TIL), an anti–IL-23p19 monoclonal antibody, in the first year of ongoing long-term extension periods for the phase 3 reSURFACE studies following 64- and 52-week base periods.

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Antibodies |  Design Principles for Bispecific IgGs, Opportunities and Pitfalls of Artificial Disulfide Bonds

Antibodies |  Design Principles for Bispecific IgGs, Opportunities and Pitfalls of Artificial Disulfide Bonds | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Bispecific antibodies (bsAbs) are antibodies with two binding sites directed at different antigens, enabling therapeutic strategies not achievable with conventional monoclonal antibodies (mAbs). Since bispecific antibodies are regarded as promising therapeutic agents, many different bispecific...
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The GAGOme: a cell-based library of displayed glycosaminoglycans

The GAGOme: a cell-based library of displayed glycosaminoglycans | Top Selling Monoclonal Antibodies 2014 | Scoop.it
A CHO cell library displaying a near-complete repertoire of glycosaminoglycan (GAG) modifications provides a resource for cell-based binding assays, recombinant proteoglycan expression, and assembly of GAG glycan microarrays.
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Development of a Hydrodynamic Cleaning Cycle for Ultrafiltration/Diafiltration Processes Used for Monoclonal Antibody Formulation - Industrial & Engineering Chemistry Research (ACS Publications)

Development of a Hydrodynamic Cleaning Cycle for Ultrafiltration/Diafiltration Processes Used for Monoclonal Antibody Formulation - Industrial & Engineering Chemistry Research (ACS Publications) | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Development of a Hydrodynamic Cleaning Cycle for Ultrafiltration/Diafiltration Processes Used for Monoclonal Antibody Formulation...

 

Ultrafiltration/diafiltration (UFDF) processes are used for final formulation of high value biotherapeutics like monoclonal antibodies. Membrane fouling and cleaning are both critical factors governing the performance of these processes, but there is very limited data on either of these phenomena, particularly at the high monoclonal antibody concentrations used in current UFDF systems. The objective of this study was to compare the effectiveness of different cleaning regimens for composite regenerated cellulose membranes in Pellicon 3 tangential flow filtration cassettes after UFDF of a monoclonal antibody product. The water permeability after UFDF was 20 ± 5% smaller than the clean membrane permeability due to fouling. Membranes could be successfully cleaned with 0.5 N NaOH, but this caused an increase in permeability and a loss in solute rejection due to an opening of the membrane pores. Cleaning with DI water was not very effective under normal flow conditions but provided very good recovery of water permeability when the flow was into the retentate exit port and out through the feed port, without any damage to the membrane as seen with NaOH. These results demonstrate the potential of using a hydrodynamic cleaning cycle without any aggressive cleaning chemicals for antibody fouled membranes.

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Native™ Shark Antibody Discovery Service - Creative Biolabs

Native™ Shark Antibody Discovery Service - Creative Biolabs | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Creative Biolabs offers native shark monoclonal antibody development for global clients through our unique Native™ shark antibody discovery service.
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Pre‐ and posttransplant use of mogamulizumab in patients with aggressive adult T‐cell leukemia‐lymphoma: A statement from key opinion leaders in Japan - Fuji - 2018 - ADVANCES IN CELL AND GENE THER...

Recently, the anti‐CCR4 antibody mogamulizumab (Moga, Kyowa Hakko Kirin Co., Ltd, Tokyo, Japan) was approved as a treatment for CCR4‐positive adult T‐cell leukemia‐lymphoma (ATL) in Japan. We use Moga before or after allogeneic hematopoietic stem cell transplantation (allo‐HSCT) in patients with aggressive ATL. A recent retrospective analysis using a database from a nationwide survey showed that the use of Moga before allo‐HSCT was associated with an increased risk of severe/steroid‐refractory acute GVHD and inferior overall survival. Meanwhile, it was reported that a number of patients with chemotherapy‐refractory ATL achieved disease control with Moga, including those who subsequently underwent allo‐HSCT. To address these issues pertaining to Moga in transplant‐eligible patients with ATL, a key opinion leader (KOL) meeting comprising hematologists and transplant physicians was conducted by Kyowa Hakko Kirin Co., Ltd. in Japan. The goal of this KOL meeting was to design a framework to guide decision‐making on the use of Moga in transplant‐eligible patients with ATL. KOLs first presented their experiences, and after a subsequent discussion, the KOLs agreed on the key scientific statement as summarized in this Expert Commentary. Our experiences suggest that a good number of patients benefited from Moga, achieving disease control that was often unattainable by conventional chemotherapies. However, as our statement is based largely on retrospective studies and real clinical practice, it requires further validation. Nevertheless, we believe that this statement should help efficiently guide decision‐making concerning Moga use in transplant‐eligible patients with ATL.
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Biology and regulation of IL-2: from molecular mechanisms to human therapy

Biology and regulation of IL-2: from molecular mechanisms to human therapy | Top Selling Monoclonal Antibodies 2014 | Scoop.it
IL-2 is well known for its crucial role in driving T cell responses. Now, with improved knowledge of its expression, signalling and regulation, the therapeutic potential of administering or inhibiting IL-2 is being explored to treat autoimmune diseases, infectious diseases and cancer.
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A Role for Fc Function in Therapeutic Monoclonal Antibody-Mediated Protection against Ebola Virus

A Role for Fc Function in Therapeutic Monoclonal Antibody-Mediated Protection against Ebola Virus | Top Selling Monoclonal Antibodies 2014 | Scoop.it
While antibodies provide protection against Ebola virus, the mechanism is unclear.
Gunn et al. dissect the contribution of Fc-functions to protection using a library
of Ebola virus-specific antibodies.
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RSV Fusion Glycoprotein – Biologic Models

RSV Fusion Glycoprotein – Biologic Models | Top Selling Monoclonal Antibodies 2014 | Scoop.it
The Human Respiratory Syncytial Virus (HSV) is a major cause of lower respiratory tract infection. Deadly to newborn babies, new therapies are being developed to keep infants alive. By understanding how dynamic structural changes in the Fusion F Glycoprotein reveal and hide binding sites, new therapies more effectively target RSV and prevent infection. Model Description 3D printed protein models of RSV Fusion F Glycoprotein visualize the conformational changes of this viral protein during membrane fusion. Each chain is colored uniquely, with one chain colored blue to red from N to C-Terminal. Protein Description Respiratory syncytial virus (RSV) invades host cells via a type I fusion (F) glycoprotein that undergoes dramatic structural rearrangements during the fusion process. Neutralizing monoclonal antibodies, such as 101F, palivizumab, and motavizumab, target two major antigenic sites on the RSV F glycoprotein. The structures of these sites as peptide complexes with motavizumab and 101F have been previously determined, but a structure for the trimeric RSV F glycoprotein ectodomain has remained elusive. To address this issue, we undertook structural and biophysical studies on stable ectodomain constructs. Here, we present the 2.8-Å crystal structure of the trimeric RSV F ectodomain in its postfusion conformation. The structure revealed that the 101F and motavizumab epitopes are present in the postfusion state and that their conformations are similar to those observed in the antibody-bound peptide structures. Both antibodies bound the postfusion F glycoprotein with high affinity in surface plasmon resonance experiments. Modeling of the antibodies bound to the F glycoprotein predicts that the 101F epitope is larger than the linear peptide and restricted to a single protomer in the trimer, whereas motavizumab likely contacts residues on two protomers, indicating a quaternary epitope. Mechanistically, these results suggest that 101F and motavizumab can bind to multiple conformations of the fusion glycoprotein and can neutralize late in the entry process. The structural preservation of neutralizing epitopes in the postfusion state suggests that this conformation can elicit neutralizing antibodies and serve as a useful vaccine antigen. PDB ID: 5TDL, 3RRR Customize 3D Print of RSV Fusion F Glycoprotein Using the interface below, configure the scale and materials using the horizontal slider and drop-down menu. PrefusionPostfusion
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Recent advances and emerging therapies in the non-surgical management of ulcerative colitis - F1000Research

Recent advances and emerging therapies in the non-surgical management of ulcerative colitis - F1000Research | Top Selling Monoclonal Antibodies 2014 | Scoop.it
The so-called “biologicals” (monoclonal antibodies to various inflammatory targets like tumor necrosis factor or integrins) have revolutionized the treatment of inflammatory bowel diseases. In ulcerative colitis, they have an established role in inducing remission in steroid-refractory disease...
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Monoclonal Antibodies

Monoclonal Antibodies | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Monoclonal antibodies (biologicals) are increasingly emerging as targeted therapies for severe asthma. Monoclonal antibodies work by binding to and blocking the function of specific target molecules. Detailed patient phenotyping is required to predict whether individual patients will respond to...
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A Tolerogenic Artificial APC Durably Ameliorates Experimental Autoimmune Encephalomyelitis by Directly and Selectively Modulating Myelin Peptide–Autoreactive CD4+ and CD8+ T Cells

A Tolerogenic Artificial APC Durably Ameliorates Experimental Autoimmune Encephalomyelitis by Directly and Selectively Modulating Myelin Peptide–Autoreactive CD4+ and CD8+ T Cells | Top Selling Monoclonal Antibodies 2014 | Scoop.it
In this study, a tolerogenic artificial APC (TaAPC) was developed to directly and selectively modulate myelin-autoreactive CD4+ and CD8+ T cells in the myelin oligodendrocyte glycoprotein (MOG)35–55 peptide–induced experimental autoimmune encephalomyelitis in C57BL/6J mice.
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Roche - Monoclonal Antibodies

Roche - Monoclonal Antibodies | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Monoclonal Antibodies Monoclonal Antibodies (MABs) are antibodies that are made by identical immune cells, cloned from a single parent cell. They are therefore of constant structure and bind to the same foreign markers (called “antigens”). The technology behind the generation of monoclonal antibodies was discovered in 1972 by César Milstein and Georges Köhler – scientists at the Roche-funded Basel Institute for Immunology – who were later to win the Nobel Prize. Monoclonal antibodies revolutionized biological research and built the basis for the use of therapeutic antibodies in medicine and for the entire biotechnology industry. At Roche, we use different approaches to generate libraries of MABs to a specific antigen. Besides living organisms, we also deploy an vitro technology, antibody phage display, to generate antibodies. Here, the antibody diversity is generated in a DNA encoded library in vitro that will lead to the display of a large collection of human antibody molecules on the surface of cultured cells. Subsequent selection and screening steps with an antigen of choice towards this pool of cells leads to the isolation of high affinity binders. In vitro display technologies allow targeting specific properties, like the antibody response on certain predefined part of the antigen. Tags: Biotechnology
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Population pharmacokinetic modeling of tildrakizumab (MK-3222), an anti–interleukin-23p19 monoclonal antibody, in healthy volunteers and subjects with psoriasis

Population pharmacokinetic modeling of tildrakizumab (MK-3222), an anti–interleukin-23p19 monoclonal antibody, in healthy volunteers and subjects with psoriasis | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Background: Tildrakizumab is an anti–IL-23p19 monoclonal antibody (mAb) in development for the treatment of chronic plaque psoriasis. In this analysis, we characterize the population pharmacokinetics (popPK) of tildrakizumab and identify covariates influencing its exposure.

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Peptide secretion triggers diabetes

Peptide secretion triggers diabetes | Top Selling Monoclonal Antibodies 2014 | Scoop.it
An autoimmune attack on cells that make the hormone insulin causes type 1 diabetes. A mouse study reveals that pancreatic-cell release of insulin peptide fragments into the bloodstream triggers this harmful process.
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