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https://www.readbyqxmd.com/read/28535451/a-novel-carbohydrate-labeling-method-utilizing-transfer-hydrogenation-mediated-reductive-amination
#1
Zsuzsanna Kovács, Gábor Papp, Henrietta Horváth, Ferenc Joó, András Guttman
One of the most frequently used high-resolution glycan analysis methods in the biopharmaceutical and biomedical fields is capillary electrophoresis with laser-induced fluorescence (CE-LIF) detection. Glycans are usually labeled by reductive amination with a charged fluorophore containing a primary amine, which reacts with the aldehyde group at the reducing end of the glycan structures. In this reaction, first a Schiff base is formed that is reduced to form a stable conjugate by a hydrogenation reagent, such as sodium cyanoborohydride...
May 13, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28535102/why-value-framework-assessments-arrive-at-different-conclusions-a-multiple-myeloma-case-study
#2
Kimberly Westrich, Lisabeth Buelt, Robert W Dubois
As the United States transitions from a volume-based health care system to one that rewards value, new frameworks are emerging to help patients, providers, and payers assess the value of medical services and biopharmaceutical products. These value assessment frameworks are intended to support various types of health care decision making. They have the potential to substantially affect patients, whether as tools for shared decision making with their doctors, as an input to care pathways used by providers, or through payer use of the frameworks to make coverage or reimbursement decisions...
June 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28534676/applications-of-raman-spectroscopy-in-biopharmaceutical-manufacturing-a-short-review
#3
Kevin Buckley, Alan G Ryder
The production of active pharmaceutical ingredients (APIs) is currently undergoing its biggest transformation in a century. The changes are based on the rapid and dramatic introduction of protein- and macromolecule-based drugs (collectively known as biopharmaceuticals) and can be traced back to the huge investment in biomedical science (in particular in genomics and proteomics) that has been ongoing since the 1970s. Biopharmaceuticals (or biologics) are manufactured using biological-expression systems (such as mammalian, bacterial, insect cells, etc...
June 2017: Applied Spectroscopy
https://www.readbyqxmd.com/read/28533680/preparation-characterization-and-in-vitro-vivo-studies-of-oleanolic-acid-loaded-lactoferrin-nanoparticles
#4
Xiaojing Xia, Haowei Liu, Huixia Lv, Jing Zhang, Jianping Zhou, Zhiying Zhao
Oleanolic acid (OA), a pentacyclic triterpene, is used to safely and economically treat hepatopathy. However, OA, a Biopharmaceutics Classification System IV category drug, has low bioavailability owing to low solubility (<1 μg/mL) and biomembrane permeability. We developed a novel OA nanoparticle (OA-NP)-loaded lactoferrin (Lf) nanodelivery system with enhanced in vitro OA dissolution and improved oral absorption and bioavailability. The OA-NPs were prepared using NP albumin-bound technology and characterized using dynamic light scattering, scanning electron microscopy, X-ray powder diffraction, differential scanning calorimetry, and in vitro dissolution test...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28528850/overview-of-solidification-techniques-for-self-emulsifying-drug-delivery-systems-from-industrial-perspective
#5
J Mandić, A Zvonar Pobirk, F Vrečer, M Gašperlin
Self-emulsifying drug delivery systems (SEDDS) are lipid formulations that improve solubility and oral bioavailability of the incorporated drug with poor biopharmaceutical properties. As liquids they are traditionally filled into soft or hard capsules. Transformation of SEDDS into solid dosage form has been extensively investigated in the recent years because solid dosage forms improve stability, handling and patient compliance. By using different solidification techniques selfemulsifying powders, granules, pellets and tablets can be produced...
May 18, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28527735/advances-in-combination-therapy-of-lung-cancer-rationales-delivery-technologies-and-dosage-regimens
#6
REVIEW
Lan Wu, Donglei Leng, Dongmei Cun, Camilla Foged, Mingshi Yang
Lung cancer is a complex disease caused by a multitude of genetic and environmental factors. The progression of lung cancer involves dynamic changes in the genome and a complex network of interactions between cancer cells with multiple, distinct cell types that form tumors. Combination therapy using different pharmaceuticals has been proven highly effective due to the ability to affect multiple cellular pathways involved in the disease progression. However, the currently used drug combination designs are primarily based on empirical clinical studies, and little attention has been given to dosage regimens, i...
May 17, 2017: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/28527520/recent-advances-in-smart-biotechnology-hydrogels-and-nanocarriers-for-tailored-bioactive-molecules-depot
#7
REVIEW
Gesmi Milcovich, Stefania Lettieri, Filipe E Antunes, Bruno Medronho, Ana C Fonseca, Jorge F J Coelho, Paolo Marizza, Francesca Perrone, Rossella Farra, Barbara Dapas, Gabriele Grassi, Mario Grassi, Silvia Giordani
Over the past ten years, the global biopharmaceutical market has remarkably grown, with ten over the top twenty worldwide high performance medical treatment sales being biologics. Thus, biotech R&D (research and development) sector is becoming a key leading branch, with expanding revenues. Biotechnology offers considerable advantages compared to traditional therapeutic approaches, such as reducing side effects, specific treatments, higher patient compliance and therefore more effective treatments leading to lower healthcare costs...
May 9, 2017: Advances in Colloid and Interface Science
https://www.readbyqxmd.com/read/28523633/synthesis-comparison-and-optimization-of-a-humic-acid-quat10-polyelectrolyte-complex-by-complexation-precipitation-versus-extrusion-spheronization
#8
Margaret Siyawamwaya, Yahya E Choonara, Pradeep Kumar, Pierre P D Kondiah, Lisa C du Toit, Viness Pillay
A novel humic acid and polyquaternium-10 polyelectrolyte complex (PEC) was synthesized utilizing two methods and the solubility and permeability of efavirenz (EFV) were established. Complexation-precipitation and extrusion-spheronization were used to synthesize and compare the drug-loaded PECs. The chemical integrity, thermo-mechanical differences, and morphology between the drug-loaded PECs produced by the two methods were assessed by attenuated total reflectance-Fourier transform infrared, differential scanning calorimetry, and SEM...
May 18, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28521373/paediatric-medicines-regulatory-and-scientific-issues
#9
Chrysa Daousani, Vangelis D Karalis
In the past, dosage regimens authorized for adults were extrapolated to children relying mainly on empirical dosage adjustments. However, children are not small adults, but a distinct and heterogeneous group in terms of physiology, disease occurrence, pharmacokinetics, pharmacodynamics and also psychological, cognitive, and behavioral aspects. Even though it would be helpful to know the physiological changes and the special drug treatment needs in children, this task could not be performed due to ethical reasons...
May 18, 2017: Drug Research
https://www.readbyqxmd.com/read/28516359/evolution-of-choice-of-solubility-and-dissolution-media-after-two-decades-of-biopharmaceutical-classification-system
#10
Nadia Bou-Chacra, Katherine Jasmine Curo Melo, Ivan Andrés Cordova Morales, Erika S Stippler, Filippos Kesisoglou, Mehran Yazdanian, Raimar Löbenberg
The introduction of the biopharmaceutics drug classification system (Biopharmaceutics Classification System (BCS)), in 1995, provided a simple way to describe the biopharmaceutics behavior of a drug. Solubility and permeability are among the major parameters, which determine the fraction dose absorbed of a drug substance and consequently its chances to be bioavailable. The purpose of this review is to summarize the evolution of the media used for determining solubility and dissolution and how this can be used in modern drug development...
May 17, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28512175/2015-2016-quality-risk-management-benchmarking-survey
#11
Kelly Waldron, Emma Ramnarine, Jeffrey Hartman
This paper investigates the concept of Quality Risk Management (QRM) maturity as it applies to the pharmaceutical and biopharmaceutical industries, using the results and analysis from a QRM benchmarking survey conducted in 2015 and 2016. QRM maturity can be defined as the effectiveness and efficiency of a quality risk management program, moving beyond 'check-the-box' compliance with guidelines such as ICH Q9 Quality Risk Management, to explore the value QRM brings to business and quality operations. While significant progress has been made towards full adoption of quality risk management principles and practices across industry, the full benefits of QRM have not yet been fully realized...
May 15, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28509555/differential-phosphoproteomic-analysis-of-recombinant-chinese-hamster-ovary-cells-following-temperature-shift
#12
Michael Henry, Martin Power, Prashant Kaushik, Orla Coleman, Martin Clynes, Paula Meleady
Phosphorylation is one of the most important post-translational modifications, playing a crucial role in regulating many cellular processes including transcription, cytoskeletal rearrangement, cell proliferation, differentiation, apoptosis and signal transduction. However, to date little work has been carried out on the phosphoproteome in CHO cells. In this study we have carried out a large scale differential phosphoproteomic analysis of recombinant CHO cells following a reduction of culture temperature (temperature shift)...
May 16, 2017: Journal of Proteome Research
https://www.readbyqxmd.com/read/28502897/a-multifunctional-%C3%AE-cyclodextrin-conjugate-photodelivering-nitric-oxide-with-fluorescence-reporting
#13
Gábor Benkovics, Marta Perez-Lloret, Damien Afonso, András Darcsi, Szabolcs Béni, Éva Fenyvesi, Milo Malanga, Salvatore Sortino
This contribution reports the design, synthesis and photochemical properties of a novel cationic, water soluble, β-cyclodextrin (βCD) conjugate integrating an anthracene moiety and a nitroaniline derivative within the primary side of the βCD scaffold. Photoinduced energy transfer between the anthracene and the nitroaniline chromophores effectively suppresses the fluorescence of the anthracene unit. Excitation with visible light triggers the release of nitric oxide (NO) from the nitroaniline chromophore, accompanied to the concomitant revival of the anthracene fluorescence, which acts as an optical reporter for detecting the amount of the NO released...
May 11, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28501469/routes-for-drug-translocation-across-the-blood-brain-barrier-exploiting-peptides-as-delivery-vectors
#14
REVIEW
Mie Kristensen, Birger Brodin
A number of potent drugs for the treatment of brain diseases are available. However, in order for them to reach their target site of action, they must pass the blood-brain barrier (BBB). The capillary endothelium comprises the major barrier of the BBB and allows only passive permeation of some small lipophilic molecules. Brain delivery of the larger biopharmaceuticals, which today includes an increasing number of novel drug entities, is therefore restricted; both due to their molecular size and their hydrophilic nature...
May 10, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28500668/advanced-multivariate-data-analysis-to-determine-the-root-cause-of-trisulfide-bond-formation-in-a-novel-antibody-peptide-fusion
#15
Stephen Goldrick, William Holmes, Nick Bond, Gareth Lewis, Marcel Kuiper, Richard Turner, Suzanne S Farid
Product quality heterogeneities, such as a trisulfide bond (TSB) formation, can be influenced by multiple interacting process parameters. Identifying their root cause is a major challenge in biopharmaceutical production. To address this issue, this paper describes the novel application of advanced multivariate data analysis (MVDA) techniques to identify the process parameters influencing TSB formation in a novel recombinant antibody-peptide fusion expressed in mammalian cell culture. The screening dataset was generated with a high-throughput (HT) micro-bioreactor system (Ambr(TM) 15) using a design of experiments (DoE) approach...
May 13, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/28500590/autolysis-of-pichia-pastoris-induced-by-cold
#16
Yaneth Bartolo-Aguilar, Luc Dendooven, Cipriano Chávez-Cabrera, Luis B Flores-Cotera, María E Hidalgo-Lara, Lourdes Villa-Tanaca, Rodolfo Marsch
The production of recombinant biopharmaceutical proteins is a multi-billion dollar market. Protein recovery represents a major part of the production costs. Pichia pastoris is one of the microbial systems most used for the production of heterologous proteins. The use of a cold-induced promoter to express lytic enzymes in the yeast after the growth stage could reduce protein recovery costs. This study shows that a cold-shock can be applied to induce lysis of the yeast cells. A strain of P. pastoris was constructed in which the endogenous eng gene encoding a putative endo-β-1,3-glucanase was overexpressed using the cold-shock induced promoter of the cctα gene from Saccharomyces cerevisiae...
December 2017: AMB Express
https://www.readbyqxmd.com/read/28497258/clinical-pharmacokinetics-and-mass-balance-of-veliparib-in-combination-with-temozolomide-in-subjects-with-nonhematologic-malignancies
#17
Silpa Nuthalapati, Wijith Munasinghe, Vincent Giranda, Hao Xiong
BACKGROUND AND OBJECTIVES: Veliparib is an orally active potent poly(ADP-ribose) polymerase (PARP) inhibitor currently in phase III clinical trials in solid tumors. This phase I study evaluated the pharmacokinetics and mass balance of veliparib administered alone and in combination with temozolomide, and assessed any potential pharmacokinetic drug-drug interaction between veliparib and temozolomide. METHODS: This was an open-label, dose-escalation study of veliparib in combination with temozolomide in 42 subjects with nonhematologic malignancies...
May 11, 2017: Clinical Pharmacokinetics
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
#18
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/28493134/glycosylation-analysis-of-therapeutic-glycoproteins-produced-in-cho-cells
#19
Sara Carillo, Stefan Mittermayr, Amy Farrell, Simone Albrecht, Jonathan Bones
In the last decades, the number of approved therapeutic proteins drugs is increasing exponentially and a large number of new therapeutic entities are progressing through clinical trials, solidifying biologics as the most promising class of pharmaceuticals on the market. Several cell lines are available for biopharmaceutical processes but mammalian cells are preferred since they give fewer problems for immunogenicity as they produce human-like post-translational modifications (PTMs). Glycosylation is the most common and complex (for both bioprocess engineering and quality control) of these modifications...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28493131/filter-aided-sample-preparation-fasp-for-improved-proteome-analysis-of-recombinant-chinese-hamster-ovary-cells
#20
Orla Coleman, Michael Henry, Martin Clynes, Paula Meleady
Chinese hamster ovary (CHO) cells are the most commonly used mammalian host cell line for biopharmaceutical production because of their ability to correctly fold and posttranslationally modify recombinant proteins that are compatible with human use. Proteomics, along with other 'omic platforms, are being used to understand the biology of CHO cells with the ultimate aim of enhancing CHO cell factories for more efficient production of biopharmaceuticals. In this chapter, we will describe an efficient protocol called Filter Aided Sample Preparation (FASP) for the extraction of proteins from CHO cells for proteomic studies...
2017: Methods in Molecular Biology
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