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https://www.readbyqxmd.com/read/28502677/biophysical-study-of-bevacizumab-structure-and-bioactivity-under-thermal-and-ph-stresses
#1
Flávia Sousa, Bruno Sarmento, Maria Teresa Neves-Petersen
The evaluation of the structural stability and bioactivity of monoclonal antibodies (mAb) is a crucial step in the development of mAb therapeutic based products, since immunogenicity needs to be avoided. In the present work, a study was carried out to understand the changes on the structure and bioactivity of mAbs induced by different pH and temperature values. Structural changes of bevacizumab were monitored using fluorescence spectroscopy, circular dichroism (CD) and Attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR)...
May 11, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28495581/dipicolinic-acid-as-a-novel-spore-inspired-excipient-for-antibody-formulation
#2
Iris L Batalha, Peng Ke, Esther Tejeda-Montes, Shahid Uddin, Christopher F van der Walle, Graham Christie
Ionic excipients are commonly used in aqueous therapeutic monoclonal antibody (mAb) formulations. Novel excipients are of industrial interest, with a recent focus on Arg salt forms and their application as viscosity reducing and stabilizing additives. Here, we report that the calcium salt of dipicolinic acid (DPA, pyridine-2,6-dicarboxylic acid), uniquely present in nature in the core of certain bacterial spores, reduces the viscosity of a mAb formulated at 150mg/mL, below that achieved by Arg hydrochloride at the same concentration (10mM)...
May 8, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28486309/rationale-for-therapeutic-drug-monitoring-of-biopharmaceuticals-in-inflammatory-diseases
#3
Gilles Paintaud, Christophe Passot, David Ternant, Bertolotto Antonio, Theodora Bejan-Angoulvant, Dora Pascual-Salcedo, Denis Mulleman
Biopharmaceuticals bring together a number of specific characteristics as compared with other drugs. However, as done for most drugs, an individual adjustment of their dose may be necessary. Similar to "chemical" drugs, biopharmaceuticals used in immuno-inflammatory diseases have a rather narrow therapeutic range, lack good early clinical or biological marker of response, have variable pharmacokinetics, and their serum concentration are most often related with response. Monoclonal antibodies (mAbs) have additional specific sources of pharmacokinetic variability...
May 5, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28479354/lyophilization-cycle-design-for-dual-chamber-cartridges-and-a-method-for-online-process-control-the-dcc-lyomate-procedure
#4
Christoph Korpus, Wolfgang Frieß
Freeze-Drying process design is a challenging task that necessitates a profound understanding of the complex interrelation between critical process parameters (e.g. shelf temperature and chamber pressure), heat transfer characteristics of the involved materials (e.g. product containers and holder devices) and critical quality attributes of the product (e.g. collapse temperatures). The Dual Chamber Cartridge "(DCC) LyoMate" (from lyophilization and automated), is a manometric temperature measurement (MTM) -based process control strategy that was developed within this study to streamline this complicated task...
May 4, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28464237/ultrafiltration-behavior-of-monoclonal-antibodies-and-fc-fusion-proteins-effects-of-physical-properties
#5
Youngbin Baek, Nripen Singh, Abhiram Arunkumar, Michael Borys, Zheng J Li, Andrew L Zydney
Ultrafiltration (UF) is used for the final concentration and formulation of essentially all antibody-based therapeutics including both monoclonal antibodies (mAbs) and Fc-fusion proteins. The objective of this study was to quantitatively compare the filtrate flux behavior for two highly purified mAbs and an Fc-fusion protein under identical flow and buffer conditions. Filtrate flux data were obtained using a Pellicon 3 tangential flow filtration cassette over a wide range of transmembrane pressures and bulk protein concentrations...
May 2, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/28464235/multi-criteria-manufacturability-indices-for-ranking-high-concentration-monoclonal-antibody-formulations
#6
Yang Yang, Ajoy Velayudhan, Nina F Thornhill, Suzanne S Farid
The need for high-concentration formulations for subcutaneous delivery of therapeutic monoclonal antibodies (mAbs) can present manufacturability challenges for the final ultrafiltration/diafiltration (UF/DF) step. Viscosity levels and the propensity to aggregate are key considerations for high-concentration formulations. This work presents novel frameworks for deriving a set of manufacturability indices related to viscosity and thermostability to rank high-concentration mAb formulation conditions in terms of their ease of manufacture...
May 2, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/28421387/pharmacokinetics-of-monoclonal-antibodies-and-fc-fusion-proteins
#7
REVIEW
Liming Liu
There are many factors that can influence the pharmacokinetics (PK) of a mAb or Fc-fusion molecule with the primary determinant being FcRn-mediated recycling. Through Fab or Fc engineering, IgG-FcRn interaction can be used to generate a variety of therapeutic antibodies with significantly enhanced half-life or ability to remove unwanted antigen from circulation. Glycosylation of a mAb or Fc-fusion protein can have a significant impact on the PK of these molecules. mAb charge can be important and variants with pI values of 1-2 unit difference are likely to impact PK with lower pI values being favorable for a longer half-life...
April 19, 2017: Protein & Cell
https://www.readbyqxmd.com/read/28402743/generation-and-application-of-monoclonal-antibody-against-lycopene
#8
Valeriy V Tsibezov, Yuriy K Bashmakov, Dmitry V Pristenskiy, Naylia A Zigangirova, Ludmila V Kostina, Natalya E Chalyk, Alexey Y Kozlov, Elena Y Morgunova, Marina P Chernyshova, Marina V Lozbiakova, Nigel H Kyle, Ivan M Petyaev
A monoclonal antibody (Mab) against lycopene was developed from hybridoma clones obtained from BALB/c mice immunized with trans-isomer of lycopene (t-lycopene, t-LC) conjugated with colloidal gold particles. An alternating immunization schedule which included injection of both formulations of immunogen (without and with Freund's adjuvant) was most effective in the elucidation of a measurable immune response to the t-Lycopene conjugate. Selected hybridoma clones were able to produce an Mab positive in competition assay...
April 12, 2017: Monoclonal Antibodies in Immunodiagnosis and Immunotherapy
https://www.readbyqxmd.com/read/28400066/development-of-a-fast-workflow-to-screen-the-charge-variants-of-therapeutic-antibodies
#9
Elsa Wagner-Rousset, Szabolcs Fekete, Laura Morel-Chevillet, Olivier Colas, Nathalie Corvaïa, Sarah Cianférani, Davy Guillarme, Alain Beck
Chemical or enzymatic modifications of therapeutic monoclonal antibodies (mAbs) having high risk towards safety and efficacy are defined as critical quality attributes (CQAs). During therapeutic mAbs process development, a variety of analytical techniques have to be used for the thorough characterization and quantitative monitoring of CQAs. This paper describes the development of a rapid analytical platform to assess and rank charge variants of mAbs. The workflow is first based on a cation exchange chromatography (CEX) comparative analysis of intact IgGs versus F(ab)'2 and Fc sub-domains generated by IdeS digestion...
February 27, 2017: Journal of Chromatography. A
https://www.readbyqxmd.com/read/28263844/a-high-throughput-bioluminescent-assay-to-monitor-the-deamidation-of-asparagine-and-isomerization-of-aspartate-residues-in-therapeutic-proteins-and-antibodies
#10
Kevin Hsiao, Juliano Alves, Rushikesh Patel, Monica Adams, Vishal Nashine, Said Goueli
Since the introduction of Herceptin and Rituximab in 1986, therapeutic antibodies have gained tremendous momentum in the treatment of broad range of several diseases such as cancer and inflammation. Selection of the clinical candidate mAb usually starts with large-scale in vitro screening and profiling of multiple mAbs to identify candidates that show high in vitro or in vivo activity, and thus it is necessarily to identify and eliminate potentially unstable mAbs during the lead selection process. Antibodies undergo a variety of degradation reactions that may result in compromised bioactivity and safety profile...
March 2, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28212986/correlating-the-effects-of-antimicrobial-preservatives-on-conformational-stability-aggregation-propensity-and-backbone-flexibility-of-an-igg1-mab
#11
Jayant Arora, Sangeeta B Joshi, C Russell Middaugh, David D Weis, David B Volkin
Multidose formulations of biotherapeutics, which offer better dosage management and reduced production costs, require the addition of antimicrobial preservatives (APs). APs have been shown, however, to decrease protein stability in solution and cause protein aggregation. In this report, the effect of 4 APs, m-cresol, phenol, phenoxyethanol, and benzyl alcohol on conformational stability, aggregation propensity, and backbone flexibility of an IgG1 mAb, mAb-4, is investigated. Compared with no preservative control, each of the APs decreased the conformational stability of mAb-4 as measured by differential scanning calorimetry and extrinsic fluorescence spectroscopy...
February 14, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28186329/effects-of-antibody-disulfide-bond-reduction-on-purification-process-performance-and-final-drug-substance-stability
#12
Wai Keen Chung, Brian Russell, Yanhong Yang, Michael Handlogten, Suzanne Hudak, Mingyan Cao, Jihong Wang, David Robbins, Sanjeev Ahuja, Min Zhu
Antibody disulfide bond reduction during monoclonal antibody (mAb) production is a phenomenon that has been attributed to the reducing enzymes from CHO cells acting on the mAb during the harvest process. However, the impact of antibody reduction on the downstream purification process has not been studied. During the production of an IgG2 mAb, antibody reduction was observed in the harvested cell culture fluid (HCCF), resulting in high fragment levels. In addition, aggregate levels increased during the low pH treatment step in the purification process...
June 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/28125318/in-silico-prediction-of-concentration-dependent-viscosity-curves-for-monoclonal-antibody-solutions
#13
Dheeraj S Tomar, Li Li, Matthew P Broulidakis, Nicholas G Luksha, Christopher T Burns, Satish K Singh, Sandeep Kumar
Early stage developability assessments of monoclonal antibody (mAb) candidates can help reduce risks and costs associated with their product development. Forecasting viscosity of highly concentrated mAb solutions is an important aspect of such developability assessments. Reliable predictions of concentration-dependent viscosity behaviors for mAb solutions in platform formulations can help screen or optimize drug candidates for flexible manufacturing and drug delivery options. Here, we present a computational method to predict concentration-dependent viscosity curves for mAbs solely from their sequence-structural attributes...
April 2017: MAbs
https://www.readbyqxmd.com/read/28094996/characterization-of-protein-excipient-microheterogeneity-in-biopharmaceutical-solid-state-formulations-by-confocal-fluorescence-microscopy
#14
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
#15
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...
March 15, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28049357/monoclonal-antibodies-formulations-of-marketed-products-and-recent-advances-in-novel-delivery-system
#16
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, more attention has been given on formulations...
April 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
#17
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
#18
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...
May 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/27916504/the-state-of-play-and-future-of-antibody-therapeutics
#19
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
#20
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
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