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https://www.readbyqxmd.com/read/28094996/characterization-of-protein-excipient-microheterogeneity-in-biopharmaceutical-solid-state-formulations-by-confocal-fluorescence-microscopy
#1
Stijn H S Koshari, Jean L Ross, Purnendu K Nayak, Isidro E Zarraga, Karthikan Rajagopal, Norman J Wagner, Abraham M Lenhoff
Protein-stabilizer microheterogeneity is believed to influence long-term protein stability in solid-state biopharmaceutical formulations and its characterization is therefore essential for the rational design of stable formulations. However, the spatial distribution of the protein and the stabilizer in a solid-state formulation is, in general, difficult to characterize because of the lack of a functional, simple, and reliable characterization technique. We demonstrate the use of confocal fluorescence microscopy with fluorescently labeled monoclonal antibodies (mAbs) and antibody fragments (Fabs) to directly visualize three-dimensional particle morphologies and protein distributions in dried biopharmaceutical formulations, without restrictions on processing conditions or the need for extensive data analysis...
January 17, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28089934/evaluation-of-aggregate-and-silicone-oil-counts-in-pre-filled-siliconized-syringes-an-orthogonal-study-characterising-the-entire-subvisible-size-range
#2
Maryam Shah, Zahra Rattray, Katie Day, Shahid Uddin, Robin Curtis, Christopher F van der Walle, Alain Pluen
Characterisation of particulates in therapeutic monoclonal antibody (mAb) formulations is routinely extended to the sub-visible size-range (0.1-10μm). Additionally, with the increased use of pre-filled syringes (PFS), particle differentiation is required between proteinaceous and non-proteinaceous particles such as silicone-oil droplets. Here, three orthogonal techniques: Raster Image Correlation Spectroscopy (RICS), Resonance Mass Measurements (RMM) and Micro-Flow Imaging (MFI), were evaluated with respect to their sub-visible particle measurement and characterisation capabilities...
January 9, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28049357/monoclonal-antibodies-formulations-of-marketed-products-and-recent-advances-in-novel-delivery-system
#3
Yanan Cui, Ping Cui, Binlong Chen, Suxin Li, Hua Guan
Monoclonal antibodies (mAbs) are extensively employed for disease diagnosis and treatment because of their high homogeneity and antigen specificity. In recent years, important outcomes have been achieved with mAbs due to their admirable therapeutic efficacy and relatively rare side effects. In clinical practice, several mAb products have been approved by regulatory entities, but their formulations have been highly specific given the complex structure and proteinaceous nature of mAbs. Thus, a great deal of attention has focused on formulations...
January 4, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28035628/effects-of-histidine-and-sucrose-on-the-biophysical-properties-of-a-monoclonal-antibody
#4
Youngbin Baek, Nripen Singh, Abhiram Arunkumar, Andrew L Zydney
PURPOSE: Histidine is a commonly used buffer in formulation of monoclonal antibodies (mAb), often with excipients like sucrose. The objective of this study was to examine the effects of both histidine and sucrose on the biophysical characteristics of a mAb. METHODS: The hydrodynamic radius of the mAb was determined by dynamic light scattering and confirmed by size exclusion chromatography. Data were also obtained for the osmotic virial coefficients (from osmotic pressure measurements), the solution viscosity, and the mAb thermal stability (using differential scanning calorimetry) at selected conditions...
December 29, 2016: Pharmaceutical Research
https://www.readbyqxmd.com/read/27943242/knockout-of-a-difficult-to-remove-cho-host-cell-protein-lipoprotein-lipase-for-improved-polysorbate-stability-in-monoclonal-antibody-formulations
#5
Josephine Chiu, Kristin N Valente, Nicholas E Levy, Lie Min, Abraham M Lenhoff, Kelvin H Lee
While the majority of host cell protein (HCP) impurities are effectively removed in typical downstream purification processes, a small population of HCPs are particularly challenging. Previous studies have identified HCPs that are challenging for a variety of reasons. Lipoprotein lipase (LPL)-a Chinese hamster ovary (CHO) HCP that functions to hydrolyze esters in triglycerides-was one of ten HCPs identified in previous studies as being susceptible to retention in downstream processing. LPL may degrade polysorbate 80 (PS-80) and polysorbate 20 (PS-20) in final product formulations due to the structural similarity between polysorbates and triglycerides...
December 12, 2016: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/27916504/the-state-of-play-and-future-of-antibody-therapeutics
#6
REVIEW
Zehra Elgundi, Mouhamad Reslan, Esteban Cruz, Vicki Sifniotis, Veysel Kayser
It has been over four decades since the development of monoclonal antibodies (mAbs) using a hybridoma cell line was first reported. Since then more than thirty therapeutic antibodies have been marketed, mostly as oncology, autoimmune and inflammatory therapeutics. While antibodies are very efficient, their cost-effectiveness has always been discussed owing to their high costs, accumulating to more than one billion dollars from preclinical development through to market approval. Because of this, therapeutic antibodies are inaccessible to some patients in both developed and developing countries...
December 2, 2016: Advanced Drug Delivery Reviews
https://www.readbyqxmd.com/read/27872686/engineering-translation-in-mammalian-cell-factories-to-increase-protein-yield-the-unexpected-use-of-long-non-coding-sineup-rnas
#7
REVIEW
Silvia Zucchelli, Laura Patrucco, Francesca Persichetti, Stefano Gustincich, Diego Cotella
Mammalian cells are an indispensable tool for the production of recombinant proteins in contexts where function depends on post-translational modifications. Among them, Chinese Hamster Ovary (CHO) cells are the primary factories for the production of therapeutic proteins, including monoclonal antibodies (MAbs). To improve expression and stability, several methodologies have been adopted, including methods based on media formulation, selective pressure and cell- or vector engineering. This review presents current approaches aimed at improving mammalian cell factories that are based on the enhancement of translation...
2016: Computational and Structural Biotechnology Journal
https://www.readbyqxmd.com/read/27855600/optimization-on-fc-for-improvement-of-stability-and-aggregation-resistance
#8
Xiaobo Chen, Fang Zeng, Tao Huang, Liang Cheng, Huan Liu, Rui Gong
Fc-based therapeutics including therapeutic full-size monoclonal antibodies (mAbs) and Fc-fusion proteins represent fastest-growing market in biopharmaceutical industrial. However, one major challenge during development of Fc-based therapeutics is how to maintain their efficacy in clinic use. Many factors may lead to failure in final marketing. For example, the stability and aggregation resistance might not be high enough for bearing the disadvantages during fermentation, purification, formulation, storage, shipment and other steps in manufacture and sale...
November 17, 2016: Current Pharmaceutical Biotechnology
https://www.readbyqxmd.com/read/27789805/processing-impact-on-monoclonal-antibody-drug-products-protein-subvisible-particulate-formation-induced-by-grinding-stress
#9
Benson Gikanga, Devon Roshan-Eisner, Robert Ovadia, Eric S Day, Oliver Boris Stauch, Yuh-Fun Maa
Subvisible particle formation in monoclonal antibody (mAb) drug product resulting from mixing and filling operations represents a significant processing risk that can lead to filter fouling and thereby lead to process delays or failures. Several previous studies from our lab and others demonstrated the formation of subvisible particulates in mAb formulations resulting from mixing operations using some bottom-mounted mixers or stirrer bars. It was hypothesized that the stress (e.g. shear/cavitation) derived from tight clearance and/or close contact between the impeller and shaft was responsible for SvP generation...
October 27, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27695087/production-quality-control-stability-and-pharmacotoxicity-of-a-malaria-vaccine-comprising-three-highly-similar-pfama1-protein-molecules-to-overcome-antigenic-variation
#10
Bart W Faber, Stephan Hellwig, Sophie Houard, Nicolas Havelange, Jürgen Drossard, Hubert Mertens, Alexander Croon, Robin Kastilan, Richard Byrne, Nicole van der Werff, Marjolein van der Eijk, Alan W Thomas, Clemens H M Kocken, Edmond J Remarque
Plasmodium falciparum apical membrane antigen 1 (PfAMA1) is a leading asexual blood stage vaccine candidate for malaria. In preparation for clinical trials, three Diversity Covering (DiCo) PfAMA1 ectodomain proteins, designed to overcome the intrinsic polymorphism that is present in PfAMA1, were produced under Good Manufacturing Practice (GMP) in Pichia pastoris. Using identical methodology, the 3 strains were cultivated in 70-L scale fed-batch fermentations and PfAMA1-DiCos were purified by two chromatography steps, an ultrafiltration/diafiltration procedure and size exclusion chromatography, resulting in highly pure (>95%) PfAMA1-DiCo1, PfAMA1 DiCo2 and PfAMA1 DiCo3, with final yields of 1...
2016: PloS One
https://www.readbyqxmd.com/read/27662755/hydrogen-deuterium-exchange-mass-spectrometry-in-biopharmaceutical-discovery-and-development-a-review
#11
REVIEW
Bin Deng, Cristina Lento, Derek J Wilson
Protein therapeutics have emerged as a major class of biopharmaceuticals over the past several decades, a trend that has motivated the advancement of bioanalytical technologies for protein therapeutic characterization. Hydrogen deuterium exchange mass spectrometry (HDX-MS) is a powerful and sensitive technique that can probe the higher order structure of proteins and has been used in the assessment and development of monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs) and biosimilar antibodies. It has also been used to quantify protein-ligand, protein-receptor and other protein-protein interactions involved in signaling pathways...
October 12, 2016: Analytica Chimica Acta
https://www.readbyqxmd.com/read/27630232/fc-receptor-mediated-activities-of-env-specific-human-monoclonal-antibodies-generated-from-volunteers-receiving-the-dna-prime-protein-boost-hiv-vaccine-dp6-001
#12
Matthew R Costa, Justin Pollara, Regina Whitney Edwards, Michael S Seaman, Miroslaw K Gorny, David C Montefiori, Hua-Xin Liao, Guido Ferrari, Shan Lu, Shixia Wang
: HIV-1 is able to elicit broadly potent neutralizing antibodies in a very small subset of individuals only after several years of infection, and therefore, vaccines that elicit these types of antibodies have been difficult to design. The RV144 trial showed that moderate protection is possible and that this protection may correlate with antibody-dependent cellular cytotoxicity (ADCC) activity. Our previous studies demonstrated that in an HIV vaccine phase I trial, the DP6-001 trial, a polyvalent Env DNA prime-protein boost formulation could elicit potent and broadly reactive, gp120-specific antibodies with positive neutralization activities...
November 15, 2016: Journal of Virology
https://www.readbyqxmd.com/read/27628177/development-of-separation-technology-for-the-removal-of-radium-223-from-targeted-thorium-conjugate-formulations-part-i-purification-of-decayed-thorium-227-on-cation-exchange-columns
#13
Janne Olsen Frenvik, Knut Dyrstad, Solveig Kristensen, Olav B Ryan
Targeted Thorium Conjugates (TTCs) are being explored as a potential future platform for specific tumour targeting pharmaceuticals. In TTCs the alpha emitting radionuclide thorium-227 ((227)Th) with a half-life of 18.697 days is labelled to targeting moieties, such as monoclonal antibodies (mAbs). The amount of daughter nuclide radium-223 ((223)Ra, t1/2 = 11.435 days) will increase during manufacture and distribution, and so a technology for purification is required to assure an acceptable level of (223)Ra is administrated to the patient...
September 15, 2016: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/27604040/development-of-downstream-processing-to-minimize-beta-glucan-impurities-in-gmp-manufactured-therapeutic-antibodies
#14
Kim Vigor, John Emerson, Robert Scott, Julia Cheek, Claire Barton, Heather J Bax, Debra H Josephs, Sophia N Karagiannis, James F Spicer, Heike Lentfer
The presence of impurities or contaminants in biological products such as monoclonal antibodies (mAb) could affect efficacy or cause adverse reactions in patients. ICH guidelines (Q6A and Q6B) are in place to regulate the level of impurities within clinical drug products. An impurity less often reported and, therefore, lacking regulatory guideline is beta-glucan. Beta-glucans are polysaccharides of d-glucose monomers linked by (1-3) beta-glycosidic bonds, and are produced by prokaryotic and eukaryotic organisms, including plants...
November 2016: Biotechnology Progress
https://www.readbyqxmd.com/read/27589351/characterizing-monoclonal-antibody-formulations-in-arginine-glutamate-solutions-using-1-h-nmr-spectroscopy
#15
Priscilla Kheddo, Matthew J Cliff, Shahid Uddin, Christopher F van der Walle, Alexander P Golovanov
Assessing how excipients affect the self-association of monoclonal antibodies (mAbs) requires informative and direct in situ measurements for highly concentrated solutions, without sample dilution or perturbation. This study explores the application of solution nuclear magnetic resonance (NMR) spectroscopy for characterization of typical mAb behavior in formulations containing arginine glutamate. The data show that the analysis of signal intensities in 1D (1)H NMR spectra, when compensated for changes in buffer viscosity, is invaluable for identifying conditions where protein-protein interactions are minimized...
August 11, 2016: MAbs
https://www.readbyqxmd.com/read/27502107/a-simultaneous-assessment-metric-for-mab-quantity-and-glycan-quality
#16
Gerald Drouillard, Gordon Hayward, Julie Vale, Roshni Dutton
As a critical quality attribute, glycosylation represents an important consideration when analyzing the success of a glycoprotein production process. Though critical, glycosylation is not the only measure of culture success; other factors, including culture size, maintenance, and productivity, are also critical. A new metric was developed to address both product quality, as measured through glycosylation, and product quantity, as measured through product concentration. A monoclonal antibody Chinese hamster ovary cell culture model system was used to assess this metric across various media formulations...
October 2016: Cytotechnology
https://www.readbyqxmd.com/read/27494835/dr5-mab-conjugated-dtic-loaded-immuno-nanoparticles-effectively-and-specifically-kill-malignant-melanoma-cells-in-vivo
#17
Baoyue Ding, Wei Zhang, Xin Wu, Jeffrey Wang, Chen Xie, Xuan Huang, Shuyu Zhan, Yongxia Zheng, Yueyan Huang, Ningyin Xu, Xueying Ding, Shen Gao
We combined chemo- and immunotherapies by constructing dual therapeutic function immuno-nanoparticles (NPs) consisting of death receptor 5 monoclonal antibody (DR5 mAb)-conjugated nanoparticles loaded with dacarbazine (DTIC) (DTIC-NPs-DR5 mAb). We determined the in vivo targeting specificity of DTIC-NPs-DR5 mAb by evaluating distribution in tumor-bearing nude mice using a real-time imaging system. Therapeutic efficacy was assessed in terms of its effect on tumor volume, survival time, histomorphology, microvessel density (MVD), and apoptotic index (AI)...
August 30, 2016: Oncotarget
https://www.readbyqxmd.com/read/27475350/approaching-the-basis-set-limit-for-dft-calculations-using-an-environment-adapted-minimal-basis-with-perturbation-theory-formulation-proof-of-concept-and-a-pilot-implementation
#18
Yuezhi Mao, Paul R Horn, Narbe Mardirossian, Teresa Head-Gordon, Chris-Kriton Skylaris, Martin Head-Gordon
Recently developed density functionals have good accuracy for both thermochemistry (TC) and non-covalent interactions (NC) if very large atomic orbital basis sets are used. To approach the basis set limit with potentially lower computational cost, a new self-consistent field (SCF) scheme is presented that employs minimal adaptive basis (MAB) functions. The MAB functions are optimized on each atomic site by minimizing a surrogate function. High accuracy is obtained by applying a perturbative correction (PC) to the MAB calculation, similar to dual basis approaches...
July 28, 2016: Journal of Chemical Physics
https://www.readbyqxmd.com/read/27452237/high-concentration-biotherapeutic-formulation-and-ultrafiltration-part-1-pressure-limits
#19
Herb Lutz, Joshua Arias, Yu Zou
High therapeutic dosage requirements and the desire for ease of administration drive the trend to subcutaneous administration using delivery systems such as subcutaneous pumps and prefilled syringes. Because of dosage volume limits, prefilled syringe administration requires higher concentration liquid formulations, limited to about 30 cP or roughly 100-300 g L(-1) for mAb's. Ultrafiltration (UF) processes are routinely used to formulate biological therapeutics. This article considers pressure constraints on the UF process that may limit its ability to achieve high final product concentrations...
July 25, 2016: Biotechnology Progress
https://www.readbyqxmd.com/read/27433338/fcrn-binding-is-not-sufficient-for-achieving-systemic-therapeutic-levels-of-immunoglobulin-g-after-oral-delivery-of-enteric-coated-capsules-in-cynomolgus-macaques
#20
Salman Muzammil, John R Mabus, Philip R Cooper, Randall J Brezski, Courtney B Bement, Rob Perkinson, Norman D Huebert, Suzanne Thompson, Dalia Levine, Connie Kliwinski, Dino Bradley, Pamela J Hornby
Although much speculation has surrounded intestinally expressed FcRn as a means for systemic uptake of orally administered immunoglobulin G (IgG), this has not been validated in translational models beyond neonates or in FcRn-expressing cells in vitro. Recently, IgG1 intestinal infusion acutely in anesthetized cynomolgus resulted in detectable serum monoclonal antibody (mAb) levels. In this study, we show that IgG2 has greater protease resistance to intestinal enzymes in vitro and mice in vivo, due to protease resistance in the hinge region...
June 2016: Pharmacology Research & Perspectives
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