keyword
MENU ▼
Read by QxMD icon Read
search

Biopharmaceuticals

keyword
https://www.readbyqxmd.com/read/29678593/characterisation-of-aptamer-bc-007-substance-and-product-using-circular-dichroism-and-nuclear-magnetic-resonance-spectroscopy
#1
Hardy Weisshoff, Katrin Wenzel, Sarah Schulze-Rothe, Heike Nikolenko, Hanna Davideit, Niels-Peter Becker, Peter Göttel, G Susan Srivatsa, Margitta Dathe, Johannes Müller, Annekathrin Haberland
Possible unwanted folding of biopharmaceuticals during manufacturing and storage has resulted in analysis schemes compared to small molecules that includes bioanalytical characterisation besides chemical characterisation. Whether bioanalytical characterisation is required for nucleotide-based drugs, may be decided on a case-by-case basis. Nucleotide-based pharmaceuticals, if chemically synthesised, occupy an intermediate position between small-molecule drugs and biologics. Here, we tested whether a physicochemical characterisation of a nucleotide-based drug substance, BC 007, was adequate, using circular dichroism (CD) spectroscopy...
April 17, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29678586/ms-based-conformation-analysis-of-recombinant-proteins-in-design-optimization-and-development-of-biopharmaceuticals
#2
REVIEW
Devrishi Goswami, Jun Zhang, Pavel V Bondarenko, Zhongqi Zhang
Mass spectrometry (MS)-based methods for analyzing protein higher order structures have gained increasing application in the field of biopharmaceutical development. The predominant methods used in this area include native MS, hydrogen deuterium exchange-MS, covalent labeling, cross-linking and limited proteolysis. These MS-based methods will be briefly described in this article, followed by a discussion on how these methods contribute at different stages of discovery and development of protein therapeutics.
April 17, 2018: Methods: a Companion to Methods in Enzymology
https://www.readbyqxmd.com/read/29678103/ouantitative-proteomic-analysis-of-cellular-responses-to-a-designed-amino-acid-feed-in-a-monoclonal-antibody-producing-chinese-hamster-ovary-cell-line
#3
Fatemeh Torkashvand, Fereidoun Mahboudi, Manouchehr Vossoughi, Elnaz Fatemi, Seyed Masoud Moosavi Basri, Amir Heydari, Behrouz Vaziri
Background: Chinese hamster ovary (CHO) cell line is considered as the most common cell line in the biopharmaceutical industry because of its capability in performing efficient post-translational modifications and producing the recombinant proteins, which are similar to natural human proteins. The optimization of the upstream process via different feed strategies has a great impact on the target molecule expression and yield. Methods: To determine and understand the molecular events beneath the feed effects on the CHO cell, a label-free quantitative proteomic analysis was applied...
April 21, 2018: Iranian Biomedical Journal
https://www.readbyqxmd.com/read/29670411/formative-usability-evaluation-of-a-fixed-dose-pen-injector-platform-device
#4
Jakob Lange, Tobias Nemeth
Background: This article for the first time presents a formative usability study of a fixed-dose pen injector platform device used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. The study was conducted with a user population of both naïve and experienced users across a range of ages. The goals of the study were to evaluate whether users could use the devices safely and effectively relying on the instructions for use (IFU) for guidance, as well as to benchmark the device against another similar injector established in the market...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29669501/biopharmaceutical-potential-of-selegiline-loaded-chitosan-nanoparticles-in-the-management-of-parkinson-s-disease
#5
Rajalakshmi Rukmangathen, Indira Muzib Yallamalli, Prasanna Raju Yalavarthi
Selegiline hydrochloride, a hydrophilic anti-Parkinson' moiety, undergoes extensive first-pass metabolism and has low bioavailability. A process to obtain of selegiline (SH) loaded chitosan nanoparticles was attempted to circumvent the above problem, through intranasal delivery. SH loaded polymeric nanoparticles were prepared by ionic gelation of chitosan with tripolyphosphate, and stabilized by tween 80/ poloxamer 188. The resulting nanoparticles (NPs) were characterized by Fourier transform infrared spectroscopy, differential scanning calorimetry, entrapment efficiency, particle size, zeta potential and surface morphology by scanning electron microscopy...
April 18, 2018: Current Drug Discovery Technologies
https://www.readbyqxmd.com/read/29666888/precise-determination-of-protein-extinction-coefficients-under-native-and-denaturing-conditions-using-sv-auc
#6
Andreas Hoffmann, Kerstin Grassl, Janine Gommert, Christian Schlesak, Alexander Bepperling
The accurate determination of protein concentration is an important though non-trivial task during the development of a biopharmaceutical. The fundamental prerequisite for this is the availability of an accurate extinction coefficient. Common approaches for the determination of an extinction coefficient for a given protein are either based on the theoretical prediction utilizing the amino acid sequence or the photometric determination combined with a measurement of absolute protein concentration. Here, we report on an improved SV-AUC based method utilizing an analytical ultracentrifuge equipped with absorbance and Rayleigh interference optics...
April 17, 2018: European Biophysics Journal: EBJ
https://www.readbyqxmd.com/read/29665036/stable-mirna-overexpression-in-human-cap-cells-engineering-alternative-production-systems-for-advanced-manufacturing-of-biologics-using-mir-136-and-mir-3074
#7
Benjamin L Weis, Nadine Guth, Simon Fischer, Silke Wissing, Simon Fradin, Karl-Heinz Holzmann, René Handrick, Kerstin Otte
Chinese hamster ovary (CHO) cells still represent the major production host for therapeutic proteins. However, multiple limitations have been acknowledged leading to the search for alternative expression systems. CEVEC's amniocyte production (CAP) cells are human production cells demonstrated to enable efficient overexpression of recombinant proteins with human glycosylation pattern. However, CAP cells have not yet undergone any engineering approaches to optimize process parameters for a cheaper and more sustainable production of biopharmaceuticals...
April 17, 2018: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/29663918/theranostic-applications-of-antibody-based-systems-in-human-diseases
#8
Fei Ding, Yangguang Gao, Xianran He, Yongmin Zhang
Since antibodies are one of the most successful classes of biopharmaceuticals for cancer treatment, it is very important to discuss the functionality and biological activity of endogenous antibodies in the diagnosis and treatment of the diseases. Antibodies act on tumor cells in diverse ways, including engaging in antibody-dependent effector mechanisms, internalizing to deliver toxins, and displaying direct effects on cells. In this review, we outline three kinds of antibody-based therapeutic systems, namely Antibody-based Drug Conjugates (Ab-DCs), Antibody-based Recruiting Small Molecules (Ab-RSMs) and Carbohydrate Epitopes Recruiting Natural Antibodies (CERNA) for human disease treatment and imaging...
March 1, 2018: Journal of Biomedical Nanotechnology
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
#9
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
#10
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/29660405/microbiome-mediated-bile-acid-modification-role-in-intestinal-drug-absorption-and-metabolism
#11
REVIEW
Elaine F Enright, Brendan T Griffin, Cormac G M Gahan, Susan A Joyce
Once regarded obscure and underappreciated, the gut microbiota (the microbial communities colonizing the gastrointestinal tract) is gaining recognition as an influencer of many aspects of human health. Also increasingly apparent is the breadth of interindividual variation in these co-evolved microbial-gut associations, presenting novel quests to explore implications for disease and therapeutic response. In this respect, the unearthing of the drug-metabolizing capacity of the microbiota has provided impetus for the integration of microbiological and pharmacological research...
April 13, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/29660390/review-of-embryo-fetal-developmental-toxicity-studies-performed-for-pharmaceuticals-approved-by-fda-in-2016-and-2017
#12
REVIEW
Paul Barrow
Details of embryo-fetal development (EFD) studies were compiled for all FDA drug approvals in 2016-17. Rats and rabbits were used for 63% of small molecule (SM) drugs. The cynomolgus monkey was used for 47% of biopharmaceuticals. Rodent studies using the clinical mAb or animal homologue replaced monkey studies under some circumstances. EFD studies were not required for anti-cancer drugs when the mode of action was associated with known developmental risk. One quarter of SM non-oncology drugs and all tested SM anti-cancer drugs were teratogenic in at least one species...
April 13, 2018: Reproductive Toxicology
https://www.readbyqxmd.com/read/29658548/a-solution-nmr-toolset-to-probe-the-molecular-mechanisms-of-amyloid-inhibitors
#13
Rashik Ahmed, Giuseppe Melacini
The self-association of the amyloid beta (Aβ) peptide into toxic oligomers is implicated in the early events leading to Alzheimer's disease (AD). Blocking the formation of Aβ oligomers and their interactions with the extracellular and cellular environment through small molecules and biopharmaceuticals is therefore a promising preventive strategy for AD. However, given the heterogeneity and transient nature of the Aβ oligomeric species, detailed structural and kinetic characterizations of such oligomers and oligomer:inhibitor complexes have proven to be challenging...
April 16, 2018: Chemical Communications: Chem Comm
https://www.readbyqxmd.com/read/29657738/lupus-community-panel-proposals-for-optimising-clinical-trials-2018
#14
REVIEW
Joan T Merrill, Susan Manzi, Cynthia Aranow, Anca Askenase, Ian Bruce, Eliza Chakravarty, Ben Chong, Karen Costenbader, Maria Dall'Era, Ellen Ginzler, Leslie Hanrahan, Ken Kalunian, Joseph Merola, Sandra Raymond, Brad Rovin, Amit Saxena, Victoria P Werth
Formidable impediments stand in the way of treatment development for lupus. These include the unwieldy size of current trials, international competition for scarce patients, complex outcome measures and a poor understanding of these outcomes in the world at large. The heterogeneity of the disease itself coupled to superimposition of variegated background polypharmacy has created enough immunological noise to virtually ensure the failure of lupus treatment trials, leaving an understandable suspicion that at least some of the results in testing failed drugs over the years may not have been negative, but merely uninterpretable...
2018: Lupus Science & Medicine
https://www.readbyqxmd.com/read/29653347/development-and-validation-of-a-bioassay-to-evaluate-binding-of-adalimumab-to-cell-membrane-anchored-tnf%C3%AE-using-flow-cytometry-detection
#15
Rosa Camacho-Sandoval, Eréndira N Sosa-Grande, Edith González-González, Alejandra Tenorio-Calvo, Carlos A López-Morales, Marco Velasco-Velázquez, Lenin Pavón-Romero, Sonia Mayra Pérez-Tapia, Emilio Medina-Rivero
Physicochemical and structural properties of proteins used as active pharmaceutical ingredients of biopharmaceuticals are determinant to carry out their biological activity. In this regard, the assays intended to evaluate functionality of biopharmaceuticals provide confirmatory evidence that they contain the appropriate physicochemical properties and structural conformation. The validation of the methodologies used for the assessment of critical quality attributes of biopharmaceuticals is a key requirement for manufacturing under GMP environments...
March 30, 2018: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29653178/surfactants-as-stabilizers-for-biopharmaceuticals-an-insight-into-the-molecular-mechanisms-for-inhibition-of-protein-aggregation
#16
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/29653105/cst3-and-gdf15-ameliorate-renal-fibrosis-by-inhibiting-fibroblast-growth-and-activation
#17
Young-Im Kim, Hyun-Woo Shin, Yang-Sook Chun, Jong-Wan Park
The final strategies to care patients with end-stage renal fibrosis rely on dialysis and kidney transplantation. Because such treatments are invasive and cause health problems eventually, it is necessary to develop new therapeutic strategies for delaying the disease progress. We here searched for cytokines showing an anti-fibrotic activity in cell-based experiments. Cystatin C (CST3) and Growth differentiation factor 15 (GDF15) were identified to have anti-fibrotic activities in a cytokine array screening. In primary fibroblasts isolated from the mouse kidneys subjected to ureteral obstruction-induced fibrosis, each cytokine induced apoptotic cell death and reduced collagen production...
April 13, 2018: Biochemical and Biophysical Research Communications
https://www.readbyqxmd.com/read/29650684/epidermal-growth-factor-receptor-tyrosine-kinase-inhibitors-for-central-nervous-system-metastases-from-non-small-cell-lung-cancer
#18
REVIEW
Manmeet S Ahluwalia, Kevin Becker, Benjamin P Levy
Central nervous system (CNS) metastases are a common complication in patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), resulting in a poor prognosis and limited treatment options. Treatment of CNS metastases requires a multidisciplinary approach, and the optimal treatment options and sequence of therapies are yet to be established. Many systemic therapies have poor efficacy in the CNS due to the challenges of crossing the blood-brain barrier (BBB), creating a major unmet need for the development of agents with good BBB-penetrating biopharmaceutical properties...
April 12, 2018: Oncologist
https://www.readbyqxmd.com/read/29649528/hyaluronic-acid-based-biopharmaceutical-delivery-and-tumor-targeted-drug-delivery-system
#19
REVIEW
Gangliang Huang, Hualiang Huang
Hyaluronic acid (HA) is a natural polysaccharide with good biocompatibility and degradability. HA and its derivatives can be used as sustained-release carriers for drugs, which can delay the release of drugs and have a long-acting effect. They can be used for the delivery of various drugs such as proteins, nucleic acids and anti-tumor drugs. HA and its derivatives can specifically bind to multiple receptors on the cell surface and can be used for targeted drug delivery, especially for the delivery of anti-tumor drugs...
April 9, 2018: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/29648833/manufacturing-amorphous-solid-dispersions-with-a-tailored-amount-of-crystallized-api-for-biopharmaceutical-testing
#20
Frank Theil, Johanna Milsmann, Sankaran Anantharaman, Holger van Lishaut
The preparation of an amorphous solid dispersion (ASD) by dissolving a poorly water-soluble active pharmaceutical ingredient (API) in a polymer matrix can improve the bioavailability by orders of magnitude. Crystallization of the API in the ASD, though, is an inherent threat for bioavailability. Commonly, the impact of crystalline API on the drug release of the dosage form is studied with samples containing spiked crystallinity. These spiked samples possess implicit differences compared to native crystalline samples, regarding size and spatial distribution of the crystals as well as their molecular environment...
April 12, 2018: Molecular Pharmaceutics
keyword
keyword
60437
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"