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https://www.readbyqxmd.com/read/26964748/analytical-detection-and-characterization-of-biopharmaceutical-glycosylation-by-ms
#1
Myung Jin Oh, Serenus Hua, Unyong Kim, Hyun Joong Kim, Jua Lee, Jae-Han Kim, Hyun Joo An
Glycosylation plays an important role in ensuring the proper structure and function of most biotherapeutic proteins. Even small changes in glycan composition, structure, or location can have a drastic impact on drug safety and efficacy. Recently, glycosylation has become the subject of increased focus as biopharmaceutical companies rush to create not only biosimilars, but also biobetters based on existing biotherapeutic proteins. Against this backdrop of ongoing biopharmaceutical innovation, updated methods for accurate and detailed analysis of protein glycosylation are critical for biopharmaceutical companies and government regulatory agencies alike...
April 2016: Bioanalysis
https://www.readbyqxmd.com/read/26554886/update-on-biosimilars-of-granulocyte-colony-stimulating-factor-when-no-news-is-good-news
#2
REVIEW
Miriam Schulz, Halvard Bonig
PURPOSE OF REVIEW: With the approval of the first biosimilar granulocyte colony-stimulating factor (G-CSF), biosimilars - copies of therapeutic biologicals whose patent protection has expired - have finally reached the US healthcare market. Its advent is an occasion for a closer look at recent insights into biosimilar G-CSF and an attempt at prognosticating the future (future role) of biosimilars in general. RECENT FINDINGS: Recent literature regarding biosimilar G-CSF orbits significantly around patient access and effects on healthcare expenditure...
January 2016: Current Opinion in Hematology
https://www.readbyqxmd.com/read/26387511/commercial-scale-biotherapeutics-manufacturing-facility-for-plant-made-pharmaceuticals
#3
REVIEW
Barry R Holtz, Brian R Berquist, Lindsay D Bennett, Vally J M Kommineni, Ranjith K Munigunti, Earl L White, Don C Wilkerson, Kah-Yat I Wong, Lan H Ly, Sylvain Marcel
Rapid, large-scale manufacture of medical countermeasures can be uniquely met by the plant-made-pharmaceutical platform technology. As a participant in the Defense Advanced Research Projects Agency (DARPA) Blue Angel project, the Caliber Biotherapeutics facility was designed, constructed, commissioned and released a therapeutic target (H1N1 influenza subunit vaccine) in <18 months from groundbreaking. As of 2015, this facility was one of the world's largest plant-based manufacturing facilities, with the capacity to process over 3500 kg of plant biomass per week in an automated multilevel growing environment using proprietary LED lighting...
October 2015: Plant Biotechnology Journal
https://www.readbyqxmd.com/read/26375407/key-strategic-factors-for-stakeholders-in-the-current-global-biosimilar-market
#4
Daniel Casey
What are the strategies of success in the global biosimilar market? In general, originators have short-term options available, such as patent litigation, but should focus on sustainable long-term strategies such as development of biobetters or incorporating biosimilars as complements to existing products. For new entrants to the market, the learning curve will be steep and only biosimilars developed to compete with the best-selling biologics will be successful over the next decade. The attitudes of physicians, patients and payers will be crucial to the reception future biosimilars will receive and it will be essential that other players contribute to this debate...
February 2016: Drug Discovery Today
https://www.readbyqxmd.com/read/26215462/basal-buffer-systems-for-a-newly-glycosylated-recombinant-human-interferon-%C3%AE-with-biophysical-stability-and-doe-approaches
#5
Nam Ah Kim, Kyoung Song, Dae Gon Lim, Shavron Hada, Young Kee Shin, Sangmun Shin, Seong Hoon Jeong
The purpose of this study was to develop a basal buffer system for a biobetter version of recombinant human interferon-β 1a (rhIFN-β 1a), termed R27T, to optimize its biophysical stability. The protein was pre-screened in solution as a function of pH (2-11) using differential scanning calorimetry (DSC) and dynamic light scattering (DLS). According to the result, its experimental pI and optimal pH range were 5.8 and 3.6-4.4, respectively. Design of experiment (DoE) approach was developed as a practical tool to aid formulation studies as a function of pH (2...
October 12, 2015: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/26177629/fusion-proteins-for-half-life-extension-of-biologics-as-a-strategy-to-make-biobetters
#6
REVIEW
William R Strohl
The purpose of making a "biobetter" biologic is to improve on the salient characteristics of a known biologic for which there is, minimally, clinical proof of concept or, maximally, marketed product data. There already are several examples in which second-generation or biobetter biologics have been generated by improving the pharmacokinetic properties of an innovative drug, including Neulasta(®) [a PEGylated, longer-half-life version of Neupogen(®) (filgrastim)] and Aranesp(®) [a longer-half-life version of Epogen(®) (epoetin-α)]...
August 2015: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/26096711/rational-design-of-biobetters-with-enhanced-stability
#7
Fabienne Courtois, Curtiss P Schneider, Neeraj J Agrawal, Bernhardt L Trout
Biotherapeutics are the fastest growing class of pharmaceutical with a rapidly evolving market facing the rise of biosimilar and biobetter products. In contrast to a biosimilar, which is derived from the same gene sequence as the innovator product, a biobetter has enhanced properties, such as enhanced efficacy or reduced immunogenicity. Little work has been carried out so far to increase the intrinsic stability of biotherapeutics via sequence changes, even though, aggregation, the primary degradation pathway of proteins, leads to issues ranging from manufacturing failure to immunological response and to loss of therapeutic activity...
August 2015: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/26011014/moss-made-pharmaceuticals-from-bench-to-bedside
#8
REVIEW
Ralf Reski, Juliana Parsons, Eva L Decker
Over the past two decades, the moss Physcomitrella patens has been developed from scratch to a model species in basic research and in biotechnology. A fully sequenced genome, outstanding possibilities for precise genome-engineering via homologous recombination (knockout moss), a certified GMP production in moss bioreactors, successful upscaling to 500 L wave reactors, excellent homogeneity of protein glycosylation, remarkable batch-to-batch stability and a safe cryopreservation for master cell banking are some of the key features of the moss system...
October 2015: Plant Biotechnology Journal
https://www.readbyqxmd.com/read/25922318/extraction-and-downstream-processing-of-plant-derived-recombinant-proteins
#9
REVIEW
J F Buyel, R M Twyman, R Fischer
Plants offer the tantalizing prospect of low-cost automated manufacturing processes for biopharmaceutical proteins, but several challenges must be addressed before such goals are realized and the most significant hurdles are found during downstream processing (DSP). In contrast to the standardized microbial and mammalian cell platforms embraced by the biopharmaceutical industry, there are many different plant-based expression systems vying for attention, and those with the greatest potential to provide inexpensive biopharmaceuticals are also the ones with the most significant drawbacks in terms of DSP...
November 1, 2015: Biotechnology Advances
https://www.readbyqxmd.com/read/25865457/biosimilar-what-it-is-not
#10
REVIEW
Fernando de Mora
A biosimilar is a high quality biological medicine shown to be in essence the same as an original product. The European Medicines Agency (EMA) paved the way in the regulatory arena by creating a safeguarding framework for the development of biosimilars. Biosimilar is thus a regulatory term that alludes to the evidence-based studies required to demonstrate such very high similarity. They are therefore not innovative products but the pathway laid down by the EMA for their approval represented a new paradigm. This has brought some confusion and has cast doubts among healthcare professionals about the scientific evidence behind their authorization...
November 2015: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/25800010/cutting-edge-mass-spectrometry-characterization-of-originator-biosimilar-and-biobetter-antibodies
#11
Alain Beck, François Debaene, Hélène Diemer, Elsa Wagner-Rousset, Olivier Colas, Alain Van Dorsselaer, Sarah Cianférani
The approval process for antibody biosimilars relies primarily on comprehensive analytical data to establish comparability and high similarity with the originator. Mass spectrometry (MS) in combination with liquid chromatography (LC) and electrophoretic methods are the corner stone for comparability and biosimilarity evaluation. In this special feature we report head-to-head comparison of trastuzumab and cetuximab with corresponding biosimilar and biobetter candidates based on cutting-edge mass spectrometry techniques such as native MS and ion-mobility MS at different levels (top, middle and bottom)...
February 2015: Journal of Mass Spectrometry: JMS
https://www.readbyqxmd.com/read/24957160/biosimilars-the-need-the-challenge-the-future-the-fda-perspective
#12
Michael S Epstein, Eli D Ehrenpreis, Prasad M Kulkarni
OBJECTIVES: This article summarizes the brief history of the biosimilars industry, the FDA's regulations and guidance for biosimilars development, and the issues and challenges facing developers and regulators in bringing biosimilars to market. METHODS: Current literature, regulations, and FDA guidance documents were summarized and interpreted to define biosimilars and to present their financial and clinical implications. RESULTS: Some biologic agents that will lose patent protection during the next few years may be replaced with lower cost follow-on biologics...
December 2014: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/24889955/regulatory-and-cost-barriers-are-likely-to-limit-biosimilar-development-and-expected-savings-in-the-near-future
#13
Henry G Grabowski, Rahul Guha, Maria Salgado
In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing biosimilars to the market currently requires large investments of money, fewer biosimilars are expected to enter the biologics market than has been the case with generic drugs entering the small-molecule drug market. Additionally, given the high regulatory hurdles to obtaining interchangeability-which would allow pharmacists to substitute a biosimilar for its reference product, subject to evolving state substitution laws-most biosimilars will likely compete as therapeutic alternatives instead of as therapeutic equivalents...
June 2014: Health Affairs
https://www.readbyqxmd.com/read/24858932/glycoengineering-of-interferon-%C3%AE-1a-improves-its-biophysical-and-pharmacokinetic-properties
#14
Kyoung Song, In-Soo Yoon, Nam Ah Kim, Dong-Hwan Kim, Jongmin Lee, Hee Jung Lee, Saehyung Lee, Sunghyun Choi, Min-Koo Choi, Ha Hyung Kim, Seong Hoon Jeong, Woo Sung Son, Dae-Duk Kim, Young Kee Shin
The purpose of this study was to develop a biobetter version of recombinant human interferon-β 1a (rhIFN-β 1a) to improve its biophysical properties, such as aggregation, production and stability, and pharmacokinetic properties without jeopardizing its activity. To achieve this, we introduced additional glycosylation into rhIFN-β 1a via site-directed mutagenesis. Glycoengineering of rhIFN-β 1a resulted in a new molecular entity, termed R27T, which was defined as a rhIFN-β mutein with two N-glycosylation sites at 80th (original site) and at an additional 25th amino acid due to a mutation of Thr for Arg at position 27th of rhIFN-β 1a...
2014: PloS One
https://www.readbyqxmd.com/read/24748667/the-esa-scenario-gets-complex-from-biosimilar-epoetins-to-activin-traps
#15
REVIEW
Wolfgang Jelkmann
Recombinant human erythropoietin (rhEpo, epoetin) has proved beneficial in preventing transfusion-dependent anaemia in patients with chronic kidney disease. Apart from copied epoetins distributed in less regulated markets, 'biosimilar' epoetins have gained currency in many regions, where they compete with the originals and with rhEpo analogues with prolonged survival in circulation ('biobetter'). Recombinant erythropoiesis stimulating agents are potent and well tolerated. However, their production is costly, and they must be administered by the parenteral route...
April 2015: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/24308020/a-report-from-cphi-worldwide-2013-fifth-annual-pre-connect-conference-october-22-24-2013-frankfurt-germany
#16
K Kuhrt, J Gilpatrick
A day before the start of the 2013 Conference on Pharmaceutical Ingredients (CPhI) Worldwide, the world's leading pharmaceutical networking event, a number of attendees gathered for the Fifth Annual Pre-Connect Conference to discuss trends in business development, manufacturing and regulatory arenas. Of the six modules presented at the meeting, one was dedicated to the sourcing environment in emerging markets, with special attention paid to developments in India and China. Other modules evaluated the current trends in the creation of generics and supergenerics in emerging markets...
November 2013: Drugs of Today
https://www.readbyqxmd.com/read/24273483/physiology-and-pharmacology-of-erythropoietin
#17
REVIEW
Wolfgang Jelkmann
Human erythropoietin (Epo) is a 30.4 kDa glycoprotein hormone composed of a single 165 amino acid residues chain to which four glycans are attached. The kidneys are the primary sources of Epo, its synthesis is controlled by hypoxia-inducible transcription factors (HIFs). Epo is an essential factor for the viability and proliferation of erythrocytic progenitors. Whether Epo exerts cytoprotection outside the bone marrow still needs to be clarified. Epo deficiency is the primary cause of the anemia in chronic kidney disease (CKD)...
October 2013: Transfusion Medicine and Hemotherapy
https://www.readbyqxmd.com/read/24007193/time-resolved-native-ion-mobility-mass-spectrometry-to-monitor-dynamics-of-igg4-fab-arm-exchange-and-bispecific-monoclonal-antibody-formation
#18
François Debaene, Elsa Wagner-Rousset, Olivier Colas, Daniel Ayoub, Nathalie Corvaïa, Alain Van Dorsselaer, Alain Beck, Sarah Cianférani
Monoclonal antibodies (mAbs) and derivatives such as antibody-drug conjugates (ADC) and bispecific antibodies (bsAb), are the fastest growing class of human therapeutics. Most of the therapeutic antibodies currently on the market and in clinical trials are chimeric, humanized, and human immunoglobulin G1 (IgG1). An increasing number of IgG2s and IgG4s that have distinct structural and functional properties are also investigated to develop products that lack or have diminished antibody effector functions compared to IgG1...
October 15, 2013: Analytical Chemistry
https://www.readbyqxmd.com/read/23949696/flexible-biomanufacturing-processes-that-address-the-needs-of-the-future
#19
Bernhard Diel, Christian Manzke, Thorsten Peuker
: As the age of the blockbuster drug recedes, the business model for the biopharmaceutical industry is evolving at an ever-increasing pace. The personalization of medicine, the emergence of biosimilars and biobetters, and the need to provide vaccines globally are just some of the factors forcing biomanufacturers to rethink how future manufacturing capability is implemented. One thing is clear: the traditional manufacturing strategy of constructing large-scale, purpose-built, capital-intensive facilities will no longer meet the industry's emerging production and economic requirements...
2014: Advances in Biochemical Engineering/biotechnology
https://www.readbyqxmd.com/read/23751726/comparability-analysis-of-anti-cd20-commercial-rituximab-and-rnai-mediated-fucosylated-antibodies-by-two-lc-ms-approaches
#20
COMPARATIVE STUDY
Chen Li, Anthony Rossomando, Shiaw-Lin Wu, Barry L Karger
In developing biosimilar or biobetter products, comparability to the reference product is required to claim similar integrity or intended purpose. In this work, an anti-CD20 monoclonal antibody developed using RNA interference to decrease core fucosylation (RNAi-mediated) was comprehensively characterized by LC-MS and compared with the commercially-available anti-CD20 rituximab (MabThera (®) ). As anticipated, < 30% core fucose was found within the RNAi-produced molecule (compared with > 90% in rituximab), and the reduction in fucose resulting in a significant improvement in FcγRΙΙΙa binding and antibody-dependent cell-mediated cytotoxicity...
July 2013: MAbs
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