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protein formulation,biopharmaceuticals

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https://www.readbyqxmd.com/read/28917988/a-comprehensive-screening-platform-for-aerosolizable-protein-formulations-for-intranasal-and-pulmonary-drug-delivery
#1
Martina Röhm, Stefan Carle, Frank Maigler, Johannes Flamm, Viktoria Kramer, Chrystelle Mavoungou, Otmar Schmid, Katharina Schindowski
Aerosolized administration of biopharmaceuticals to the airways is a promising route for nasal and pulmonary drug delivery, but - in contrast to small molecules - little is known about the effects of aerosolization on safety and efficacy of biopharmaceuticals. Proteins are sensitive against aerosolization-associated shear stress. Tailored formulations can shield proteins and enhance permeation, but formulation development requires extensive screening approaches. Thus, the aim of this study was to develop a cell-based in vitro technology platform that includes screening of protein quality after aerosolization and transepithelial permeation...
September 13, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28865117/development-of-a-general-defined-medium-for-pichia-pastoris
#2
Catherine Bartlett Matthews, Angel Kuo, Kerry Routenberg Love, J Christopher Love
Pichia pastoris is widely used as a host for recombinant protein production. More than 500 proteins have been expressed in the organism at a variety of cultivation scales, from small shake flasks to large bioreactors. Large-scale fermentation strategies typically employ chemically-defined growth medium because of its greater batch-to-batch consistency and in many cases, lower costs compared to complex medium. For biopharmaceuticals, defined growth medium may also simplify downstream purification and regulatory documentation...
September 2, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/28818376/an-overview-on-the-strategies-to-exploit-rice-endosperm-as-production-platform-for-biopharmaceuticals
#3
REVIEW
Fumio Takaiwa, Yuhya Wakasa, Shimpei Hayashi, Taiji Kawakatsu
Cereal seed has been utilized as production platform for high-value biopharmaceutical proteins. Especially, protein bodies (PBs) in seeds are not only natural specialized storage organs of seed storage proteins (SSPs), but also suitable intracellular deposition compartment for recombinant proteins. When various recombinant proteins were produced as secretory proteins by attaching N terminal ER signal peptide and C terminal KDEL endoplasmic reticulum (ER) retention signal or as fusion proteins with SSPs, high amounts of recombinant proteins can be predominantly accumulated in the PBs...
October 2017: Plant Science: An International Journal of Experimental Plant Biology
https://www.readbyqxmd.com/read/28716374/high-throughput-quantitation-of-fc-containing-recombinant-proteins-in-cell-culture-supernatant-by-fluorescence-polarization-spectroscopy
#4
Ben Thompson, Jerry Clifford, Mike Jenns, Andrew Smith, Ray Field, Kalpana Nayyar, David C James
Measurement of recombinant protein product titer critically underpins all biopharmaceutical manufacturing process development, as well as diverse research and discovery activity. Here, we describe a simple rapid (<2 min per 96 samples) 96-well microplate-based assay that enables high-throughput quantitation of recombinant immunoglobulin G and Fc-containing IgG derivatives in mammalian cell culture supernatant over a wide dynamic range of 2.5-80 mg/L, using microplate fluorescence polarization (FP) spectroscopy...
October 1, 2017: Analytical Biochemistry
https://www.readbyqxmd.com/read/28699244/biophysical-characterization-of-layer-by-layer-synthesis-of-aptamer-drug-microparticles-for-enhanced-cell-targeting
#5
Kei X Tan, Michael K Danquah, Amandeep Sidhu, Sie Yon Lau, Clarence M Ongkudon
Targeted delivery of drug molecules to specific cells in mammalian systems demonstrates a great potential to enhance the efficacy of current pharmaceutical therapies. Conventional strategies for pharmaceutical delivery are often associated with poor therapeutic indices and high systemic cytotoxicity, and this results in poor disease suppression, low surviving rates, and potential contraindication of drug formulation. The emergence of aptamers has elicited new research interests into enhanced targeted drug delivery due to their unique characteristics as targeting elements...
July 11, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/28649842/lipo-oligomer-nanoformulations-for-targeted-intracellular-protein-delivery
#6
Peng Zhang, Benjamin Steinborn, Ulrich Lächelt, Stefan Zahler, Ernst Wagner
Here, we report novel lipo-oligoaminoamide nanoformulations for targeted intracellular protein delivery. Formulations are generated by first bioreversibly conjugating a sequence-defined amphiphilic lipo-oligomer 728 to the cargo protein via disulfide bonds, followed by formulation of the formed 728-SS-protein conjugate with different helper lipids in various compositions. The triblock oligoaminoamide 728 contains cysteines for reversible covalent protein conjugation and cross-link-stabilization of formed nanoparticles, polyethylene glycol (PEG) for shielding, and providing a hydrophilic domain, eight cationizable succinoyl tetraethylene pentamine (Stp) repeats for endosomal buffering and escape into the cytosol, and a tetra-oleic acid block for hydrophobic stabilization...
July 10, 2017: Biomacromolecules
https://www.readbyqxmd.com/read/28625725/closing-the-gap-counting-and-sizing-of-particles-across-submicron-range-by-flow-cytometry-in-therapeutic-protein-products
#7
Liling Zhang, Shuai Shi, Valentyn Antochshuk
Quantification and size distribution characterization of subvisible particles in parenteral biopharmaceutics, present as both proteinaceous and nonproteinaceous particles in the size range from 0.1 to 100 μm, are important for biopharmaceutical industry due to their potential safety and efficacy implications. Although a number of analytical techniques are available to count and size subvisible particles, characterization of particles ≤2 μm remains a significant challenge due to technical limitations of existing particle counting instruments...
June 15, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28624419/thermo-optical-protein-characterization-for-straightforward-preformulation-development
#8
Randy Wanner, Dennis Breitsprecher, Stefan Duhr, Philipp Baaske, Gerhard Winter
The determination of protein unfolding and aggregation characteristics during preformulation is of major significance for the development of biopharmaceuticals. The aim of this study was to investigate the feasibility of a new immobilization- and label-free thermo-optical approach as an orthogonal method for material and time-saving early formulation and drugability screenings. In the experimental setup used, changes in the intrinsic tryptophan fluorescence of the protein were measured during IR laser-induced heating of the samples...
June 15, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28617076/characterization-of-highly-concentrated-antibody-solution-a-toolbox-for-the-description-of-protein-long-term-solution-stability
#9
Marie-Therese Schermeyer, Anna K Wöll, Bas Kokke, Michel Eppink, Jürgen Hubbuch
High protein titers are gaining importance in biopharmaceutical industry. A major challenge in the development of highly concentrated mAb solutions is their long-term stability and often incalculable viscosity. The complexity of the molecule itself, as well as the various molecular interactions, make it difficult to describe their solution behavior. To study the formulation stability, long- and short-range interactions and the formation of complex network structures have to be taken into account. For a better understanding of highly concentrated solutions, we combined established and novel analytical tools to characterize the effect of solution properties on the stability of highly concentrated mAb formulations...
June 15, 2017: MAbs
https://www.readbyqxmd.com/read/28593474/high-throughput-prediction-approach-for-monoclonal-antibody-aggregation-at-high-concentration
#10
Mitja Zidar, Ana Šušterič, Miha Ravnik, Drago Kuzman
PURPOSE: Characterization of the monoclonal antibody aggregation process and identification of stability factors that could be used as indicators of aggregation propensity with an emphasis on a large number of samples and low protein material consumption. METHODS: Differential scanning calorimetry, dynamic light scattering and size exclusion chromatography were used as the main methodological approaches. Conformational stability, colloidal stability and aggregation kinetics were assessed for two different IgG monoclonal antibody (mAbs) subclasses...
September 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28496465/effect-of-nonionic-surfactants-dodecyl-maltoside-and-polysorbate-20-on-prevention-of-aggregation-and-conformational-changes-of-recombinant-human-ifn%C3%AE-_1b-induced-by-light
#11
Najmeh Mahjoubi, Ahmad Fazeli, Rassoul Dinarvand, Mohammad Reza Khoshayand, Maryam Shekarchi, Mohammad Reza Fazeli
Liquid protein formulations are prone to form aggregates. The effect of nonionic surfactants such as Polysorbate 20 (PS 20) and n-Dodecyl β-D-maltoside (DDM) on the prevention of aggregation and conformational changes of recombinant human IFNβ-1b (rhIFN β_1b) was explored. Polysorbate has been used in formulations of protein pharmaceuticals. There have been concerns about using PS 20 due to its residual peroxide content which may negatively affect protein efficacy. n-Dodecyl β-D-maltoside has been of interest and shown to be highly effective in prevention of aggregation...
2017: Iranian Journal of Pharmaceutical Research: IJPR
https://www.readbyqxmd.com/read/28476626/nile-red-fluorescence-spectrum-decomposition-enables-rapid-screening-of-large-protein-aggregates-in-complex-biopharmaceutical-formulations-like-influenza-vaccines
#12
Ziya Sahin, Senem Akkoc, Ronald Neeleman, Jonathan Haines, Veysel Kayser
The extensive presence of large (high molecular weight) protein aggregates in biopharmaceutical formulations is a concern for formulation stability and possibly safety. Tests to screen large aggregate content in such bioformulations are therefore needed for rapid and reliable quality control in industrial settings. Herein, non-commercial seasonal influenza split-virus vaccine samples, produced using various strains and extracted from selected industrial processing steps, were used as model complex bioformulations...
May 2, 2017: Vaccine
https://www.readbyqxmd.com/read/28440620/water-proton-nmr-a-tool-for-protein-aggregation-characterization
#13
Marc B Taraban, Roberto A DePaz, Brian Lobo, Y Bruce Yu
Formulation stability is a critical attribute of any protein-based biopharmaceutical drug due to a protein's inherent tendency to aggregate. Advanced analytical techniques currently used for characterization of protein aggregates are prone to a number of limitations and usually require additional manipulations with the sample, such as dilution, separation, labeling, and use of special cuvettes. In the present work, we compared conventional techniques for the analysis of protein aggregates with a novel approach that employs the water proton transverse relaxation rate R2((1)H2O)...
May 3, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28342056/formulation-delivery-and-stability-of-bone-morphogenetic-proteins-for-effective-bone-regeneration
#14
REVIEW
Inas El Bialy, Wim Jiskoot, M Reza Nejadnik
Bone morphogenetic proteins (BMPs) are responsible for bone formation during embryogenesis and bone regeneration and remodeling. The osteoinductive action of BMPs, especially BMP-2 and BMP-7, has led to their use in a range of insurmountable treatments where intervention is required for effective bone regeneration. Introduction of BMP products to the market, however, was not without reports of multiple complications and side effects. Aiming for optimization of the therapeutic efficacy and safety, efforts have been focused on improving the delivery of BMPs to lower the administered dose, localize the protein, and prolong its retention time at the site of action...
June 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28341309/polymorphic-distribution-of-proteins-in-solution-by-mass-spectrometry-the-analysis-of-insulin-analogues
#15
Maely P Fávero-Retto, Luiz Henrique Guerreiro, Cássio M Pessanha, Leonardo C Palmieri, Luís Maurício T R Lima
The characterization of conformational and oligomeric distribution of proteins is of paramount importance for the understanding of the correlation between structure and function. Among the bioanalytical approaches currently available, the electrospray ionization-mass spectrometry (ESI-MS) coupled to ion mobility spectrometry (IMS) is the best suited for high resolution identification with high sensitivity, allowing the in situ separation of oligomeric and conformational species. We tested the performance of the ESI-MS technique along with the IMS separation approach on a broad variety of insulin and insulin analogues with distinct oligomeric distribution pattern...
January 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28302541/trends-on-analytical-characterization-of-polysorbates-and-their-degradation-products-in-biopharmaceutical-formulations
#16
REVIEW
Ariadna Martos, Wendelin Koch, Wim Jiskoot, Klaus Wuchner, Gerhard Winter, Wolfgang Friess, Andrea Hawe
Among many other applications, polysorbates (PSs) are used as the most common surfactants in biopharmaceutical products in particular to protect proteins against interfacial stress. Structural heterogeneity, presence of degradants and other impurities, and tendency for degradation are interrelated features found in commercial PSs with a direct impact on their functional properties in biopharmaceutical products. These pose a challenge for the analytical characterization of PSs at different stages of product development...
July 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28247754/small-sized-mpeg-plga-nanoparticles-of-schisantherin-a-with-sustained-release-for-enhanced-brain-uptake-and-anti-parkinsonian-activity
#17
Tongkai Chen, Chuwen Li, Ye Li, Xiang Yi, Ruibing Wang, Simon Ming-Yuen Lee, Ying Zheng
Schisantherin A (SA) is a promising anti-Parkinsonism natural product. However, its poor water solubility and rapid serum clearance impose significant barriers to delivery of SA to the brain. This work aimed to develop SA in a nanoparticle formulation that extended SA circulation in the bloodstream and consequently an increased brain uptake and thus to be potentially efficacious for the treatment of Parkinson's disease (PD). Spherical SA nanoparticles with a mean particle size of 70 nm were prepared by encapsulating SA into methoxy poly(ethylene glycol)-block-poly(d,l)-lactic-co-glycolic acid (mPEG-PLGA) nanoparticles (SA-NPs) with an encapsulation efficiency of ∼91% and drug loading of ∼28%...
March 22, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28213844/self-nanoemulsified-drug-delivery-system-of-hydrochlorothiazide-for-increasing-dissolution-rate-and-diuretic-activity
#18
Cassiana Mendes, Aline Buttchevitz, Jéssica Henriques Kruger, Thiago Caon, Patricia de Oliveira Benedet, Elenara Lemos-Senna, Marcos Antônio Segatto Silva
Hydrochlorothiazide (HCTZ) is a class IV drug according to the Biopharmaceutical Classification System. This study aimed the development of self-nanoemulsifying drug delivery system (SNEDDS) for HCTZ as an approach to overcome the biopharmaceutical limitations. Pre-formulation screening and ternary phase diagrams were carried out to select the oil phase, the surfactant, and the co-surfactant as the amount of each constituent. The optimized formulations, with reduced amount of surfactant, and composed of medium chain triglycerides, Cremophor EL and Transcutol P did not affect the pH or show drug incompatibilities...
February 17, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28130198/effect-of-peg-molecular-weight-and-pegylation-degree-on-the-physical-stability-of-pegylated-lysozyme
#19
Josefine Morgenstern, Pascal Baumann, Carina Brunner, Jürgen Hubbuch
During production, purification, formulation, and storage proteins for pharmaceutical or biotechnological applications face solution conditions that are unfavorable for their stability. Such harmful conditions include extreme pH changes, high ionic strengths or elevated temperatures. The characterization of the main influencing factors promoting undesired changes of protein conformation and aggregation, as well as the manipulation and selective control of protein stabilities are crucially important to biopharmaceutical research and process development...
March 15, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28120725/bile-salt-stabilized-vesicles-bilosomes-a-novel-nano-pharmaceutical-design-for-oral-delivery-of-proteins-and-peptides
#20
Javed Ahmad, Madhur Singhal, Saima Amin, Md Rizwanullah, Sohail Akhter, Mohammad Amjad Kamal, Nafis Haider, Patrick Midoux, Chantal Pichon
With the advent of novel vesicular drug delivery systems especially bilosomes, for large molecular weight proteins and peptides, their oral administration seems a viable approach. These nano-vesicles have shown promising results for the effective delivery of insulin and other therapeutics, perhaps due to their structural composition. The present review has elaborated the biopharmaceutical challenges for the oral delivery of therapeutic proteins and peptides as well as presented a novel approach to deliver the essential macromolecules through oral route as bilosomes...
January 24, 2017: Current Pharmaceutical Design
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