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https://www.readbyqxmd.com/read/28440620/water-proton-nmr-a-tool-for-protein-aggregation-characterization
#1
Marc B Taraban, Roberto A DePaz, Brian Lobo, Yihua 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(1H2O)...
April 25, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28438697/predicting-drug-loading-in-pla-peg-nanoparticles
#2
M Meunier, A Goupil, P Lienard
Polymer nanoparticles present advantageous physical and biopharmaceutical properties as drug delivery systems compared to conventional liquid formulations. Active pharmaceutical ingredients (APIs) are often hydrophobic, thus not soluble in conventional liquid delivery. Encapsulating the drugs in polymer nanoparticles can improve their pharmacological and bio-distribution properties, preventing rapid clearance from the bloodstream. Such nanoparticles are commonly made of non-toxic amphiphilic self-assembling block copolymers where the core (poly-[D,L-lactic acid] or PLA) serves as a reservoir for the API and the external part (Poly-(Ethylene-Glycol) or PEG) serves as a stealth corona to avoid capture by macrophage...
April 21, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28432429/enhanced-production-of-recombinant-proteins-by-a-small-molecule-protein-synthesis-enhancer-in-combination-with-an-antioxidant-in-recombinant-chinese-hamster-ovary-cells
#3
Joseph Camire, Dongjoo Kim, Soonjo Kwon
The improvement in the production of recombinant proteins has been linked in a number of small molecules such as carboxylic acids to the inhibition of histone deacetylase, leading to increased transcription of genes. However, carboxylic acids such as pentanoic acid and butanoic acid have been shown to promote an apoptotic response in Chinese hamster ovary (CHO) cell culture. Supplementation of cultures with antioxidants has shown the ability to reduce the apoptotic response of carboxylic acid supplementation, leading to increased therapeutic protein production...
April 21, 2017: Bioprocess and Biosystems Engineering
https://www.readbyqxmd.com/read/28429292/preparation-of-chloramphenicol-amino-acid-combinations-exhibiting-enhanced-dissolution-rates-and-reduced-drug-induced-oxidative-stress
#4
Vanesa B Sterren, Virginia Aiassa, Claudia Garnero, Yamila Garro Linck, Ana K Chattah, Gustavo A Monti, Marcela R Longhi, Ariana Zoppi
Chloramphenicol is an old antibiotic agent that is re-emerging as a valuable alternative for the treatment of multidrug-resistant pathogens. However, it exhibits suboptimal biopharmaceutical properties and toxicity profiles. In this work, chloramphenicol was combined with essential amino acids (arginine, cysteine, glycine, and leucine) with the aim of improving its dissolution rate and reduce its toxicity towards leukocytes. The chloramphenicol/amino acid solid samples were prepared by freeze-drying method and characterized in the solid state by using Fourier transform infrared spectroscopy, powder X-ray diffraction, differential scanning calorimetry, scanning electron microscopy, and solid-state nuclear magnetic resonance...
April 20, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28429059/a-novel-method-to-recover-inclusion-body-protein-from-recombinant-e-coli-fed-batch-processes-based-on-phage-%C3%AE-x174-derived-lysis-protein-e
#5
Daniela Ehgartner, Patrick Sagmeister, Timo Langemann, Andrea Meitz, Werner Lubitz, Christoph Herwig
Production of recombinant proteins as inclusion bodies is an important strategy in the production of technical enzymes and biopharmaceutical products. So far, protein from inclusion bodies has been recovered from the cell factory through mechanical or chemical disruption methods, requiring additional cost-intensive unit operations. We describe a novel method that is using a bacteriophage-derived lysis protein to directly recover inclusion body protein from Escherichia coli from high cell density fermentation process: The recombinant inclusion body product is expressed by using a mixed feed fed-batch process which allows expression tuning via adjusting the specific uptake rate of the inducing substrate...
April 20, 2017: Applied Microbiology and Biotechnology
https://www.readbyqxmd.com/read/28428810/recent-achievements-obtained-by-chloroplast-transformation
#6
REVIEW
Muhamed Adem, Dereje Beyene, Tileye Feyissa
Chloroplasts play a great role for sustained wellbeing of life on the planet. They have the power and raw materials that can be used as sophisticated biological factories. They are rich in energy as they have lots of pigment-protein complexes capable of collecting sunlight, in sugar produced by photosynthesis and in minerals imported from the plant cell. Chloroplast genome transformation offers multiple advantages over nuclear genome which among others, include: integration of the transgene via homologus recombination that enables to eliminate gene silencing and position effect, higher level of transgene expression resulting into higher accumulations of foreign proteins, and significant reduction in environmental dispersion of the transgene due to maternal inheritance which helps to minimize the major critic of plant genetic engineering...
2017: Plant Methods
https://www.readbyqxmd.com/read/28427886/identification-of-excipients-for-stabilizing-fiberless-adenovirus-as-biopharmaceuticals
#7
Grit Kupgan, Shyamal P Choudhari, Nicholas H Flynn, Adane Nigatu, Sravanthi Vupputuri, William D Picking, Wendy L Picking, Joshua D Ramsey
Reducing the promiscuous tropism of native adenovirus by using fiberless adenovirus is advantageous towards its use as a gene therapy vector or vaccine component. The removal of the fiber protein on native adenovirus abrogates several undesirable interactions; however, this approach decreases the particle's physical stability. In order to create stable fiberless adenovirus for pharmaceutical use, the effects of temperature and pH on the particle's stability profile must be addressed. Our results indicate that the stability of fiberless adenovirus is increased when it is stored in mildly acidic conditions around pH 6...
April 17, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28426392/design-and-validation-of-a-new-method-to-detect-and-quantify-residual-host-cell-dna-in-human-recombinant-erythropoietin-repo
#8
Shima Zamanian, Samira Mohammadi-Yeganeh, Vahid Kia, Hooman Kaghazian, Mahdi Paryan
During the purification of Human Recombinant EPO (rEPO) from host cells, residual DNA may remain in final products. This contamination is a risk factor for patients and may result in the inactivation of some tumor suppressor genes (TSG) or activation of oncogenes if its concentration is more than the standard defined by WHO. Based on WHO's criteria, acceptable level of residual DNA in biopharmaceuticals is less than 10-100 picograms/dose. In this study we have designed a sensitive and specific Quantitative Real-time PCR assay for detection of residual DNA in human rEPO products...
April 20, 2017: Preparative Biochemistry & Biotechnology
https://www.readbyqxmd.com/read/28425637/cover-image-volume-114-number-6-june-2017
#9
Lisa Goers, Catherine Ainsworth, Cher Hui Goey, Cleo Kontoravdi, Paul S Freemont, Karen M Polizzi
Cover Legend The cover image, by Lisa Goers et al., is based on the Article Whole-cell Escherichia coli lactate biosensor for monitoring mammalian cell cultures during biopharmaceutical production, DOI: 10.1002/bit.26254.
June 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/28423954/the-design-and-scale-up-of-spray-dried-particle-delivery-systems
#10
Ali Al-Khattawi, Andrew Bayly, Andy Phillips, David Wilson
The rising demand for pharmaceutical particles with tailored physico-chemical properties has opened new markets for the spray drying technology especially for solubility enhancement, improvement of inhalation medicines and stabilization of biopharmaceuticals. Despite this, the literature on spray drying is scattered and often does not address the fundamental principles underpinning the robust development of pharmaceutical products. It is therefore necessary to present a clearer picture of the field and highlight the principles and factors influencing particle design and scale-up...
April 19, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28422566/content-uniformity-testing-for-stratified-samples-via-parametric-tolerance-interval-testing
#11
Steven Novick, Buffy Hudson-Curtis
Historically in the biopharmaceutical setting, USP <905>has been used to establish that a batch of drug product has acceptable content uniformity. More recently, alternative approaches, such as the two one-sided parametric tolerance interval test (PTI-TOST), have been proposed to establish content uniformity. Traditionally, the PTI-TOST is implemented as a sequential, two-tiered test, under the generally accepted assumption that the data are independently and identically distributed. Since the material is sequenced through the manufacturing process over a period of time, there are conceptually arguable locations within each batch, for instance: beginning, middle, and end...
April 19, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28419778/single-and-multiple-dose-pharmacokinetics-of-once-daily-formulations-of-raltegravir
#12
Rajesh Krishna, Matthew L Rizk, Patrick Larson, Valerie Schulz, Filippos Kesisoglou, Radu Pop
A new once-daily formulation of raltegravir, an integrase strand transfer inhibitor indicated in combination with other antiretroviral drugs for the treatment of human immunodeficiency virus-1 infection, is under development. Single-dose and steady-state pharmacokinetics of 1200 mg for 2 formulations of raltegravir were characterized in 2 open-label phase 1 studies in healthy male and female subjects aged 18 to 55 years. The new raltegravir 600-mg formulation had a higher relative bioavailability compared with the 400-mg tablets...
April 17, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28418683/physical-characterization-of-tobramycin-inhalation-powder-ii-state-diagram-of-an-amorphous-engineered-particle-formulation
#13
Dan Miller, Trixie Tan, John Nakamura, Richard Malcolmson, Tom Tarara, Jeff Weers
Tobramycin Inhalation Powder (TIP) is a spray-dried engineered particle formulation used in TOBI® Podhaler®, a drug/device combination for treatment of cystic fibrosis. A TIP particle consists of two phases: amorphous, glassy tobramycin sulfate and a gel-phase phospholipid (DSPC). The objective of this work was to characterize both the amorphous and gel phases following exposure of TIP to a broad range of relative humidity and temperature. Because, in principle, changes in either particle morphology or the solid-state form of the drug could affect drug delivery or biopharmaceutical properties, understanding physical stability was critical to development and registration of this product...
April 18, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28418635/enhancing-protein-production-yield-from-cho-cells-by-crispr-interference-crispri
#14
Chih-Che Shen, Li-Yu Sung, Shih-Yeh Lin, Mei-Wei Lin, Yu-Chen Hu
CHO cell is an important host for biopharmaceutical production. Generation of stable CHO cell typically requires co-integration of dhfr and foreign gene into chromosomes and subsequent methotrexate (MTX) selection for co-amplification of dhfr and foreign gene. CRISPR interference (CRISPRi) is an emerging system that effectively suppresses gene transcription through the coordination of dCas9 protein and guide RNA (gRNA). However, CRISPRi has yet to be exploited in CHO cells. Here we constructed vectors expressing the functional CRISPRi system and proved effective CRISPRi-mediated suppression of dhfr transcription in CHO cells...
April 18, 2017: ACS Synthetic Biology
https://www.readbyqxmd.com/read/28416374/comparing-originator-biologics-and-biosimilars-a-review-of-the-relevant-issues
#15
REVIEW
Corrado Blandizzi, Pier Luigi Meroni, Giovanni Lapadula
PURPOSE: We provide a review of current knowledge on comparability between biosimilars and originator biologics in view of the continuous evolution occurring in this highly dynamic area. METHODS: English-language literature indexed in MEDLINE was explored, without time limits, to July 31, 2016, using the terms biosimilar, biotechnologic drug, biologic drug, monoclonal antibody, fusion protein, and anti-tumor necrosis factor. The reference lists of identified articles were examined carefully for additional pertinent publications...
April 14, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28415414/bionanocomposite-systems-based-on-montmorillonite-and-biopolymers-for-the-controlled-release-of-olanzapine
#16
Artur S Oliveira, Ana C S Alcântara, Sibele B C Pergher
Olanzapine (OLZ) is a drug that is used in the treatment of schizophrenia and other psychoses, and it belongs to the thienobenzodiazepine class. The OLZ molecule has low solubility decreasing bioavailability, but has high permeability in membrane biological being classified as a Class II drug substance according to the Biopharmaceutics Classification System. It was reported many side effects of administering OLZ orally. So, in order to increase the bioavailability of drug and possibly reducing some of side effects, this paper proposes a new material able to controllably release the drug in the body...
June 1, 2017: Materials Science & Engineering. C, Materials for Biological Applications
https://www.readbyqxmd.com/read/28414239/a-novel-sample-preparation-for-shotgun-proteomics-characterization-of-hcps-in-antibodies
#17
Lihua Huang, Ning Wang, Charles E Mitchell, Tammy J Brownlee, Steven R Maple, Michael R De Felippis
Residual host cell proteins (HCPs) in biopharmaceuticals derived from recombinant DNA technology can present potential safety risks to patients or compromise product stability. Thus, the downstream purification process is designed to demonstrate robust removal of these impurities. ELISA using polyclonal anti-HCP antibodies as reagents for capture, detection and quantitation purposes is most commonly used to monitor HCP removal during process development but this technique has limitations. More recently, LC-MS for residual HCP characterization has emerged as a powerful tool to support purification process development...
April 17, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28414067/effective-strategies-for-host-cell-protein-clearance-in-downstream-processing-of-monoclonal-antibodies-and-fc-fusion-proteins
#18
REVIEW
Yifeng Li
Recombinant therapeutic proteins are typically produced through cell culture process. Host cell proteins (HCPs) are endogenous proteins derived from the host cells used for such bioproduction. HCPs form a major class of process-related impurities and even at low levels they can potentially compromise the safety and efficacy of biopharmaceuticals. Therefore, they need to be adequately removed via the downstream process. HCPs are complex mixtures with diverse physiochemical properties, and certain subpopulations can bind to the intended product...
April 13, 2017: Protein Expression and Purification
https://www.readbyqxmd.com/read/28410804/neutron-reflectivity-measurement-of-protein-a-antibody-complex-at-the-solid-liquid-interface
#19
Alice R Mazzer, Luke A Clifton, Tatiana Perevozchikova, Paul D Butler, Christopher J Roberts, Daniel G Bracewell
Chromatography is a ubiquitous unit operation in the purification of biopharmaceuticals yet few studies have addressed the biophysical characterisation of proteins at the solution-resin interface. Chromatography and other adsorption and desorption processes have been shown to induce protein aggregation which is undesirable in biopharmaceutical products. In order to advance understanding of how adsorption processes might impact protein stability, neutron reflectivity was used to characterise the structure of adsorbed immunoglobulin G (IgG) on model surfaces...
April 1, 2017: Journal of Chromatography. A
https://www.readbyqxmd.com/read/28410475/exploring-the-potential-of-saccharomyces-cerevisiae-for-biopharmaceutical-protein-production
#20
REVIEW
Guokun Wang, Mingtao Huang, Jens Nielsen
Production of recombinant proteins by yeast plays a vital role in the biopharmaceutical industry. It is therefore desirable to develop yeast platform strains for over-production of various biopharmaceutical proteins, but this requires fundamental knowledge of the cellular machinery, especially the protein secretory pathway. Integrated analyses of multi-omics datasets can provide comprehensive understanding of cellular function, and can enable systems biology-driven and mathematical model-guided strain engineering...
April 11, 2017: Current Opinion in Biotechnology
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