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protein formulation,biopharmaceuticals

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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
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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...
March 14, 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
#7
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
#8
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
#9
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
#10
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
https://www.readbyqxmd.com/read/28094996/characterization-of-protein-excipient-microheterogeneity-in-biopharmaceutical-solid-state-formulations-by-confocal-fluorescence-microscopy
#11
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/27911829/supramolecular-pegylation-of-biopharmaceuticals
#12
Matthew J Webber, Eric A Appel, Brittany Vinciguerra, Abel B Cortinas, Lavanya S Thapa, Siddharth Jhunjhunwala, Lyle Isaacs, Robert Langer, Daniel G Anderson
The covalent modification of therapeutic biomolecules has been broadly explored, leading to a number of clinically approved modified protein drugs. These modifications are typically intended to address challenges arising in biopharmaceutical practice by promoting improved stability and shelf life of therapeutic proteins in formulation, or modifying pharmacokinetics in the body. Toward these objectives, covalent modification with poly(ethylene glycol) (PEG) has been a common direction. Here, a platform approach to biopharmaceutical modification is described that relies on noncovalent, supramolecular host-guest interactions to endow proteins with prosthetic functionality...
December 13, 2016: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/27889071/using-x-ray-crystallography-to-simplify-and-accelerate-biologics-drug-development
#13
REVIEW
Mark L Brader, Edward N Baker, Michael F Dunn, Thomas M Laue, John F Carpenter
Every major biopharmaceutical company incorporates a protein crystallography unit that is central to its structure-based drug discovery efforts. Yet these capabilities are rarely leveraged toward the formal higher order structural characterization that is so challenging but integral to large-scale biologics manufacturing. Although the biotech industry laments the shortcomings of its favored biophysical techniques, x-ray crystallography is not even considered for drug development. Why not? We suggest that this is due, at least in part, to outdated thinking (for a recent industry-wide survey, see Gabrielson JP, Weiss IV WF...
February 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27855600/optimization-on-fc-for-improvement-of-stability-and-aggregation-resistance
#14
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/27837528/preparation-of-drv-liposomes
#15
Sophia G Antimisiaris
Dried reconstituted vesicles (DRV) are liposomes that are formulated under mild conditions and have the capability to entrap substantially high amounts of hydrophilic solutes (compared to other types of liposomes). These characteristics make this liposome type ideal for entrapment of labile substances, as peptide, protein, or DNA vaccines, or in general biopharmaceuticals and sensitive drugs. In this chapter, all possible types of DRV liposomes (with respect to the encapsulated molecule characteristics and/or their applications in therapeutics) are introduced, and preparation methodologies (for each type) are described in detail...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/27836754/impact-of-additives-on-the-formation-of-protein-aggregates-and-viscosity-in-concentrated-protein-solutions
#16
COMPARATIVE STUDY
Katharina Christin Bauer, Susanna Suhm, Anna Katharina Wöll, Jürgen Hubbuch
In concentrated protein solutions attractive protein interactions may not only cause the formation of undesired aggregates but also of gel-like networks with elevated viscosity. To guarantee stable biopharmaceutical processes and safe formulations, both phenomenons have to be avoided as these may hinder regular processing steps. This work screens the impact of additives on both phase behavior and viscosity of concentrated protein solutions. For this purpose, additives known for stabilizing proteins in solution or modulating the dynamic viscosity were selected...
January 10, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/27813291/exploring-the-linkage-between-cell-culture-process-parameters-and-downstream-processing-utilizing-a-plackett-burman-design-for-a-model-monoclonal-antibody
#17
Cyrus D Agarabi, Brittany K Chavez, Scott C Lute, Erik K Read, Sarah Rogstad, David Awotwe-Otoo, Matthew R Brown, Michael T Boyne, Kurt A Brorson
Linkage of upstream cell culture with downstream processing and purification is an aspect of Quality by Design crucial for efficient and consistent production of high quality biopharmaceutical proteins. In a previous Plackett-Burman screening study of parallel bioreactor cultures we evaluated main effects of 11 process variables, such as agitation, sparge rate, feeding regimens, dissolved oxygen set point, inoculation density, supplement addition, temperature, and pH shifts. In this follow-up study, we observed linkages between cell culture process parameters and downstream capture chromatography performance and subsequent antibody attributes...
November 4, 2016: Biotechnology Progress
https://www.readbyqxmd.com/read/27776770/control-of-globular-protein-thermal-stability-in-aqueous-formulations-by-the-positively-charged-amino-acid-excipients
#18
Lauren Platts, Samuel J Darby, Robert J Falconer
The positively charged amino acids are commonly used excipients in biopharmaceutical formulations for stabilization of therapeutic proteins, yet the mechanisms for their modulation of protein stability are poorly understood. In this study, both lysine and histidine are shown to affect the thermal stability of myoglobin, bovine serum albumin, and lysozyme through a combination of mechanisms governed by their respective functional side chains and glycine, similar to arginine. This study provides evidence that at low concentrations, lysine and histidine interact with proteins by a combination of (1) direct electrostatic interactions with negatively charged side chains, (2) possible binding to high-affinity hydrophobic binding sites, and (3) glycine-mediated weak interactions with peptide backbone and polar side chains...
October 21, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27740776/oral-delivery-of-a-nanocrystal-formulation-of-schisantherin-a-with-improved-bioavailability-and-brain-delivery-for-the-treatment-of-parkinson-s-disease
#19
Tongkai Chen, Chuwen Li, Ye Li, Xiang Yi, Simon Ming-Yuen Lee, Ying Zheng
Schisantherin A (SA) is a promising anti-Parkinsonism Chinese herbal medicine but with poor water solubility and challenges to be delivered to the brain. We formulated SA as nanocrystals (SA-NC), aiming to improve its solubility and pharmacokinetic profile and thus provide a potential therapeutic agent for the treatment of Parkinson's disease (PD). The rod-shaped SA-NC had a particle size of ∼160 nm with 33.3% drug loading, and the nanocrystals exhibited a fast dissolution rate in vitro. The intact drug nanocrystals could be internalized into Madin-Darby canine kidney (MDCK) cells, which were followed by rapid intracellular release, and most of the drug was transported to the basolateral side in its soluble form...
November 7, 2016: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/27663383/a-comprehensive-evaluation-of-nanoparticle-tracking-analysis-nanosight-for-characterization-of-proteinaceous-submicron-particles
#20
Xinsheng Tian, M Reza Nejadnik, Dorrit Baunsgaard, Anette Henriksen, Christian Rischel, Wim Jiskoot
Nanoparticle tracking analysis (NTA) has attracted great interest for application in the field of submicron particle characterization for biopharmaceuticals. It has the virtue of direct sample visualization and particle-by-particle tracking, but the complexity of method development has limited its routine applicability. We systematically evaluated data collection and processing parameters as well as sample handling methods using shake-stressed protein samples. The camera shutter and gain were identified as the key factors influencing NTA results...
November 2016: Journal of Pharmaceutical Sciences
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