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protein formulation,biopharmaceuticals

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https://www.readbyqxmd.com/read/29715533/lycopene-loaded-whey-protein-isolate-nanoparticles-an-innovative-endeavor-for-enhanced-bioavailability-of-lycopene-and-anti-cancer-activity
#1
Ashay Jain, Gajanand Sharma, Gargi Ghoshal, Prashant Kesharwani, Bhupinder Singh, U S Shivhare, O P Katare
The work entails a novel strategy of formulating the lycopene loaded whey protein isolate nanoparticles (LYC-WPI-NPs) solely using the rational blend of biomacromolecule without using equipment-intensive techniques. The LYC-WPI-NPs were fabricated as a substantial drug delivery platform, with maximum entrapment, spatial and controlled release manners, exceptional plasma concentration, and perspective for discrepancy delivery of therapeutics. Prepared nano-formulations were measured in ultra-fine size (100-350 nm) with sphere-shaped...
April 28, 2018: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29663661/amino-acid-based-advanced-liquid-formulation-development-for-highly-concentrated-therapeutic-antibodies-balances-physical-and-chemical-stability-and-low-viscosity
#2
Kristina Kemter, Jens Altrichter, Roland Derwand, Thomas Kriehuber, Eva Reinauer, Martin Scholz
To develop highly concentrated therapeutic antibodies enabling convenient subcutaneous application, well stabilizing pharmaceutical formulations with low viscosities are considered to be key. The purpose of this study was to select specific amino acid combinations that reduce and balance aggregation, fragmentation and chemical degradation and also lower viscosity of highly concentrated liquid antibodies. As a model, the therapeutically well-established antibody trastuzumab (25 - >200 mg/mL) in liquid formulation was used...
April 16, 2018: Biotechnology Journal
https://www.readbyqxmd.com/read/29663323/single-pass-diafiltration-integrated-into-a-fully-continuous-mab-purification-process
#3
Joanna Rucker-Pezzini, Lindsay Arnold, Kevin Hill-Byrne, Tom Sharp, Maksim Avazhanskiy, Chris Forespring
The concept of continuous manufacturing has gained significant interest from the biopharmaceutical industry over the past several years. Benefits include increased manufacturing productivity, improved quality control, reduction in plant footprint, and more flexible management of facility capacity. There are several technologies currently available that enable continuous processing for chromatography and ultrafiltration. However, a single pass diafiltration design that meets the required small molecule clearance and has been integrated into a fully continuous monoclonal antibody purification process has not been previously published...
April 16, 2018: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/29653178/surfactants-as-stabilizers-for-biopharmaceuticals-an-insight-into-the-molecular-mechanisms-for-inhibition-of-protein-aggregation
#4
Andrea Arsiccio, Roberto Pisano
PURPOSE: Surfactants are common stabilizers, often added to biopharmaceuticals formulations, but the mechanisms at the basis of their activity are unclear. The aim of this work is to provide insight into the molecular factors underlying surfactant effectiveness as protectants. METHODS: Molecular Dynamics simulations of human growth hormone (hGH) in the presence of Tween 20 were performed. The effect of Tween 20 was compared with the activity of commonly used protectants, such as the disaccharides...
April 10, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29644623/single-pass-diafiltration-integrated-into-a-fully-continuous-mab-purification-process
#5
Joanna Rucker-Pezzini, Lindsay Arnold, Kevin Hill-Byrne, Tom Sharp, Maksim Avazhanskiy, Chris Forespring
The concept of continuous manufacturing has gained significant interest from the biopharmaceutical industry over the past several years. Benefits include increased manufacturing productivity, improved quality control, reduction in plant footprint, and more flexible management of facility capacity. There are several technologies currently available that enable continuous processing for chromatography and ultrafiltration. However, a single pass diafiltration design that meets the required small molecule clearance and has been integrated into a fully continuous monoclonal antibody purification process has not been previously published...
April 12, 2018: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/29604370/the-application-of-step-technology%C3%A2-for-particle-and-protein-dispersion-detection-studies-in-biopharmaceutical-research
#6
J Gross, N Herrmann, M Blech, S R Pinnapireddy, P Garidel, U Bakowsky
Particle detection and analysis techniques are essential in biopharmaceutical industries to evaluate the quality of various parenteral formulations regarding product safety, product quality and to meet the regulations set by the authority agencies. Several particle analysis systems are available on the market, but for the operator, it is quite challenging to identify the suitable method to analyze the sample. At the same time these techniques are the basis to gain a better understanding in biophysical processes, e...
March 28, 2018: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29537925/modification-of-the-kinetic-stability-of-immunoglobulin-g-by-solvent-additives
#7
Jonas V Schaefer, Erik Sedlák, Florian Kast, Michal Nemergut, Andreas Plückthun
Biophysical properties of antibody-based biopharmaceuticals are a critical part of their release criteria. In this context, finding the appropriate formulation is equally important as optimizing their intrinsic biophysical properties through protein engineering, and both are mutually dependent. Most previous studies have empirically tested the impact of additives on measures of colloidal stability, while mechanistic aspects have usually been limited to only the thermodynamic stability of the protein. Here we emphasize the kinetic impact of additives on the irreversible denaturation steps of immunoglobulins G (IgG) and their antigen-binding fragments (Fabs), as these are the key committed steps preceding aggregation, and thus especially informative in elucidating the molecular parameters of activity loss...
March 14, 2018: MAbs
https://www.readbyqxmd.com/read/29528066/clarifying-the-role-of-cryo-and-lyo-protectants-in-the-biopreservation-of-proteins
#8
Andrea Arsiccio, Roberto Pisano
Biopharmaceuticals are frequently stored in the frozen state to avoid rapid degradation. Moreover, therapeutic proteins are frequently made into a dried form to provide long-term storage. However, both freezing and drying stresses can result in protein unfolding and aggregation. Thus, a proper formulation, containing suitable excipients, must be used to avoid loss of activity. Here, the conformational stability of a model protein, human growth hormone, is studied during freezing, and in the dried state as well, using molecular dynamics...
March 28, 2018: Physical Chemistry Chemical Physics: PCCP
https://www.readbyqxmd.com/read/29522899/impact-of-fast-and-conservative-freeze-drying-on-product-quality-of-protein-mannitol-sucrose-glycerol-lyophilizates
#9
Jacqueline Horn, Julia Schanda, Wolfgang Friess
PURPOSE: Mannitol/sucrose formulations are employed to generate lyophilizates for biopharmaceuticals with an elegant cake appearance. The aim of this study was to dry protein/mannitol/sucrose formulations as fast as possible without loss of cake appearance and protein stability. Glycerol was included as potential additional protein stabilizer. Three proteins (lysozyme and two monoclonal antibodies) at low and high concentration were analyzed comparing fast with conservative freeze-drying...
June 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29511969/ionic-liquids-as-biocompatible-stabilizers-of-proteins
#10
REVIEW
Mouhamad Reslan, Veysel Kayser
Ionic liquids (ILs) have recently emerged as versatile solvents and additives in the field of biotechnology, particularly as stabilizers of proteins and enzymes. Of interest to the biotechnology industry is the formulation of stable biopharmaceuticals, therapeutic proteins, and vaccines which have revolutionized the treatment of many diseases including debilitating conditions such as cancers and auto-immune diseases. The stabilization of therapeutic proteins is typically achieved using additives that prevent unfolding and aggregation of these proteins during manufacture, transport, and long-term storage...
March 6, 2018: Biophysical Reviews
https://www.readbyqxmd.com/read/29430179/sodium-deoxycholate-decorated-zein-nanoparticles-for-a-stable-colloidal-drug-delivery-system
#11
Agnese Gagliardi, Donatella Paolino, Michelangelo Iannone, Ernesto Palma, Massimo Fresta, Donato Cosco
Background: The use of biopolymers is increasing in drug delivery, thanks to the peculiar properties of these compounds such as their biodegradability, availability, and the possibility of modulating their physico-chemical characteristics. In particular, protein-based systems such as albumin are able to interact with many active compounds, modulating their biopharmaceutical properties. Zein is a protein of 20-40 kDa made up of many hydrophobic amino acids, generally regarded as safe (GRAS) and used as a coating material...
2018: International Journal of Nanomedicine
https://www.readbyqxmd.com/read/29388872/improving-titer-while-maintaining-quality-of-final-formulated-drug-substance-via-optimization-of-cho-cell-culture-conditions-in-low-iron-chemically-defined-media
#12
Jianlin Xu, Matthew S Rehmann, Xuankuo Xu, Chao Huang, Jun Tian, Nan-Xin Qian, Zheng Jian Li
During biopharmaceutical process development, it is important to improve titer to reduce drug manufacturing costs and to deliver comparable quality attributes of therapeutic proteins, which helps to ensure patient safety and efficacy. We previously reported that relative high-iron concentrations in media increased titer, but caused unacceptable coloration of a fusion protein during early-phase process development. Ultimately, the fusion protein with acceptable color was manufactured using low-iron media, but the titer decreased significantly in the low-iron process...
April 2018: MAbs
https://www.readbyqxmd.com/read/29339145/ocular-delivery-of-proteins-and-peptides-challenges-and-novel-formulation-approaches
#13
Abhirup Mandal, Dhananjay Pal, Vibhuti Agrahari, Hoang My Trinh, Mary Joseph, Ashim K Mitra
The impact of proteins and peptides on the treatment of various conditions including ocular diseases over the past few decades has been advanced by substantial breakthroughs in structural biochemistry, genetic engineering, formulation and delivery approaches. Formulation and delivery of proteins and peptides, such as monoclonal antibodies, aptamers, recombinant proteins and peptides to ocular tissues poses significant challenges owing to their large size, poor permeation and susceptibility to degradation. A wide range of advanced drug delivery systems including polymeric controlled release systems, cell-based delivery and nanowafers are being exploited to overcome the challenges of frequent administration to ocular tissues...
January 13, 2018: Advanced Drug Delivery Reviews
https://www.readbyqxmd.com/read/29315487/using-extensional-flow-to-reveal-diverse-aggregation-landscapes-for-three-igg1-molecules
#14
Leon F Willis, Amit Kumar, John Dobson, Nicholas J Bond, David Lowe, Richard Turner, Sheena E Radford, Nikil Kapur, David J Brockwell
Monoclonal antibodies (mAbs) currently dominate the biopharmaceutical sector due to their potency and efficacy against a range of disease targets. These proteinaceous therapeutics are, however, susceptible to unfolding, mis-folding, and aggregation by environmental perturbations. Aggregation thus poses an enormous challenge to biopharmaceutical development, production, formulation, and storage. Hydrodynamic forces have also been linked to aggregation, but the ability of different flow fields (e.g., shear and extensional flow) to trigger aggregation has remained unclear...
May 2018: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/29288093/notorious-but-not-understood-how-liquid-air-interfacial-stress-triggers-protein-aggregation
#15
Ellen Koepf, Simon Eisele, Rudolf Schroeder, Gerald Brezesinski, Wolfgang Friess
Protein aggregation is a major challenge in the development of biopharmaceuticals. As the pathways of aggregation are manifold, good understanding of the mechanisms behind is essential. Particularly, the presence of liquid-air interfaces has been identified to trigger the formation of large protein particles. Investigations of two monoclonal antibodies (IgGs) at the liquid-air interface exhibited the formation of a highly compressible film. An inhomogeneous protein distribution across the interface with areas of increased packing density was discovered by Brewster-Angle microscopy...
February 15, 2018: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29258899/preferential-exclusion-mechanism-by-carbohydrates-on-protein-stabilization-using-thermodynamic-evaluation
#16
Nam Ah Kim, Ritu Thapa, Seong Hoon Jeong
Carbohydrates are widely used as additives for biopharmaceutical formulations, but the mechanisms by which they confer stability to and their applicability on protein stability remain undiscovered. Herein, we aimed to elucidate these mechanisms, by studying the thermodynamic changes using isothermal titration calorimetry and micro-differential scanning calorimetry. Furthermore, conventional biophysical analyses, namely circular dichroism, dynamic light scattering, and size-exclusion chromatography, were used to investigate the beneficial effects of carbohydrates on protein stability...
April 1, 2018: International Journal of Biological Macromolecules
https://www.readbyqxmd.com/read/29197156/identification-of-aggregates-in-therapeutic-formulations-of-recombinant-full-length-factor-viii-products-by-sedimentation-velocity-analytical-ultracentrifugation
#17
J F Healey, E T Parker, P Lollar
Essentials Factor VIII inhibitors are the most serious complication in patients with hemophilia A. Aggregates in biopharmaceutical products are an immunogenic risk factor. Aggregates were identified in recombinant full-length factor VIII products. Aggregates in recombinant factor VIII products are identified by analytical ultracentrifugation. SUMMARY: Background The development of inhibitory anti-factor VIII antibodies is the most serious complication in the management of patients with hemophilia A...
February 2018: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/29192343/a-view-on-the-importance-of-multi-attribute-method-for-measuring-purity-of-biopharmaceuticals-and-improving-overall-control-strategy
#18
Richard S Rogers, Michael Abernathy, Douglas D Richardson, Jason C Rouse, Justin B Sperry, Patrick Swann, Jette Wypych, Christopher Yu, Li Zang, Rohini Deshpande
Today, we are experiencing unprecedented growth and innovation within the pharmaceutical industry. Established protein therapeutic modalities, such as recombinant human proteins, monoclonal antibodies (mAbs), and fusion proteins, are being used to treat previously unmet medical needs. Novel therapies such as bispecific T cell engagers (BiTEs), chimeric antigen T cell receptors (CARTs), siRNA, and gene therapies are paving the path towards increasingly personalized medicine. This advancement of new indications and therapeutic modalities is paralleled by development of new analytical technologies and methods that provide enhanced information content in a more efficient manner...
November 30, 2017: AAPS Journal
https://www.readbyqxmd.com/read/29183741/arginine-as-an-excipient-for-protein-freeze-drying-a-mini-review
#19
Peter Stärtzel
Successful development of marketable freeze-dried protein formulations requires adequate stabilization of the active biopharmaceutical ingredient. The choice of a stabilizer must therefore be based on sound knowledge of the physical and chemical properties of the excipients and specific needs of the protein component. Amino acids, such as arginine, have exhibit cryo- and lyoprotective effects similar to those of sugars and polymers and may therefore be considered to be an alternative approach to these established formulation strategies...
April 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29141152/t-m-values-and-unfolded-fraction-can-predict-aggregation-rates-for-granulocyte-colony-stimulating-factor-variant-formulations-but-not-under-predominantly-native-conditions
#20
Mathew J Robinson, Paul Matejtschuk, Adrian F Bristow, Paul A Dalby
Protein engineering and formulation optimization strategies can be taken to minimize protein aggregation in the biopharmaceutical industry. Short-term stability measures such as the midpoint transition temperature (Tm ) for global unfolding provide convenient surrogates for longer-term (e.g., 2-year) degradation kinetics, with which to optimize formulations on practical time-scales. While successful in some cases, their limitations have not been fully evaluated or understood. Tm values are known to correlate with chemical degradation kinetics for wild-type granulocyte colony stimulating factor (GCSF) at pH 4-5...
January 2, 2018: Molecular Pharmaceutics
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