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https://www.readbyqxmd.com/read/29474833/one-step-integrated-clarification-and-purification-of-a-monoclonal-antibody-using-protein-a-mag-sepharose-beads-and-a-cgmp-compliant-high-gradient-magnetic-separator
#1
Moritz Ebeler, Ola Lind, Nils Norrman, Ronnie Palmgren, Matthias Franzreb
Monoclonal antibodies are a dominant component of today's biopharmaceutical market and are typically purified by classical platform processes. However, high costs and rising demands are drivers for the development of new, efficient and flexible integrated purification processes. Currently, high-gradient magnetic separation as a direct capturing tool for protein purification suffers from the lack of suitable GMP-compliant separation equipment for industrial scale. As a solution for this bottleneck, we present a purification process for a monoclonal antibody directly from CHO cell culture by use of protein A-functionalized magnetic particles together with the first pilot-scale GMP-compliant 'rotor-stator' high-gradient magnetic separator...
February 20, 2018: New Biotechnology
https://www.readbyqxmd.com/read/29471208/understanding-biopharmaceutical-production-at-single-nucleotide-resolution-using-ribosome-footprint-profiling
#2
REVIEW
Ioanna Tzani, Craig Monger, Paul Kelly, Niall Barron, Ronan M Kelly, Colin Clarke
Biopharmaceuticals such as monoclonal antibodies have revolutionised the treatment of a variety of diseases. The production of recombinant therapeutic proteins, however, remains expensive due to the manufacturing complexity of mammalian expression systems and the regulatory burden associated with administrating these medicines to patients in a safe and efficacious manner. In recent years, academic and industrial groups have begun to develop a greater understanding of the biology of host cell lines, such as Chinese hamster ovary (CHO) cells and utilise that information for process development and cell line engineering...
February 19, 2018: Current Opinion in Biotechnology
https://www.readbyqxmd.com/read/29464592/delivery-considerations-of-highly-viscous-polymeric-fluids-mimicking-concentrated-biopharmaceuticals-assessment-of-injectability-via-measurement-of-total-work-done-w-t
#3
Qiangnan Zhang, Mona A Fassihi, Reza Fassihi
An account is given of the recent development of the highly viscous complex biopharmaceuticals in relation to syringeability and injectability. The specific objective of this study is to establish a convenient method to examine problem of the injectability for the needle-syringe-formulation system when complex formulations with diverse viscosities are used. This work presents the inter-relationship between needle size, syringe volume, viscosity, and injectability of polymeric solutions having typical viscosities encountered in concentrated biologics, by applying a constant probe crosshead speed on the plunger-syringe needle assembly and continuously recording the force-distance profiles...
February 20, 2018: AAPS PharmSciTech
https://www.readbyqxmd.com/read/29462683/overcoming-the-polycation-dilemma-explorative-studies-to-characterise-the-efficiency-and-biocompatibility-of-newly-designed-lipofection-reagents
#4
Julia Giselbrecht, Christopher Janich, Shashank Reddy Pinnapireddy, Gerd Hause, Udo Bakowsky, Christian Wölk, Andreas Langner
In this explorative study of the novel cationic lipid OO4 in two different formulations the complex formation with DNA, the biopharmaceutical stability of the lipid/DNA complexes in physiological media, and the transfection efficiency were analysed. We investigated liposomes composed of two binary mixtures of OO4 with either DOPE or DPPE as co-lipids in the molar ratio of 1:3. These formulations were compared with regard to their ability to bind the DNA using gel retardation electrophoresis, ethidium bromide exclusion and zeta potential measurements...
February 17, 2018: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29458685/optimizing-host-cell-physiology-and-stress-avoidance-for-the-production-of-recombinant-human-tumour-necrosis-factor-%C3%AE-in-escherichia-coli
#5
Tania Selas Castiñeiras, Steven G Williams, Antony Hitchcock, Jeffrey A Cole, Daniel C Smith, Tim W Overton
As high-level recombinant protein production (RPP) exerts a massive stress on the production host, an extensive literature on RPP optimization focuses on separating the growth phase from RPP production once sufficient biomass has been obtained. The aim of the current investigation was to optimize the benefits of the relatively neglected alternative strategy to achieve high-level RPP during growth by minimizing stress on the host. High yields of the biopharmaceutical recombinant human tumour necrosis factor alpha (rhTNFα) were obtained by fed-batch fermentation relevant to industrial production based upon parameters that most severely affected RPP in preliminary laboratory scale batch cultures...
February 14, 2018: Microbiology
https://www.readbyqxmd.com/read/29455987/design-and-biological-response-of-doxycycline-loaded-chitosan-microparticles-for-periodontal-disease-treatment
#6
Silvana Gjoseva, Nikola Geskovski, Simona Dimchevska Sazdovska, Riste Popeski-Dimovski, Gjorgji Petruševski, Kristina Mladenovska, Katerina Goracinova
The aim of this study was to develop chitosan (CS) microparticulated mucoadhesive drug delivery system (DDS) with improved therapeutic performance and biological responce. Ionotropic gelation/spray drying process was used for preparation of doxycycline hyclate (DOXY) loaded low and medium molecular weight (LMw and MMw) CS/sodium tripolyphosphate microparticles (CS/TPP MPs), further coated with ethyl cellulose (EC) using coacervation/solvent displacement technique. The relevant physico-chemical and biopharmaceutical properties were optimized using experimental design approach...
April 15, 2018: Carbohydrate Polymers
https://www.readbyqxmd.com/read/29453714/backbone-1-h-13-c-and-15-n-assignments-of-the-extracellular-region-of-human-fc%C3%AE-receptor-iiib
#7
Rina Yogo, Saeko Yanaka, Koichi Kato
Fcγ receptor (FcγR) promotes various immune responses through interactions with the Fc portion of immunoglobulin G (IgG). FcγRIIIb is a glycosylphosphatidylinositol-linked protein expressed on neutrophils and triggers degranulation and opsonic phagocytosis. The extracellular region of FcγR is composed of two Ig-fold domains and can be cleaved as a soluble form (sFcγRIIIb), which is also reactive with complement receptor type 3. Although structure and Fc interaction of sFcγRIIIb have been characterized by X-ray crystallography, little has been known about its structure in solution...
February 16, 2018: Biomolecular NMR Assignments
https://www.readbyqxmd.com/read/29452210/computer-simulations-for-bioequivalence-trials-selection-of-analyte-in-bcs-class-ii-and-iv-drugs-with-first-pass-metabolism-two-metabolic-pathways-and-intestinal-efflux-transporter
#8
V Mangas-Sanjuan, C Navarro-Fontestad, A García-Arieta, I F Trocóniz, M Bermejo
A semi-physiological two compartment pharmacokinetic model with two active metabolites (primary (PM) and secondary metabolites (SM)) with saturable and non-saturable pre-systemic efflux transporter, intestinal and hepatic metabolism has been developed. The aim of this work is to explore in several scenarios which analyte (parent drug or any of the metabolites) is the most sensitive to changes in drug product performance (i.e. differences in in vivo dissolution) and to make recommendations based on the simulations outcome...
February 13, 2018: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29450829/artificial-lipid-membrane-permeability-method-for-predicting-intestinal-drug-transport-probing-the-determining-step-in-the-oral-absorption-of-sulfadiazine-influence-of-the-formation-of-binary-and-ternary-complexes-with-cyclodextrins
#9
Alicia Delrivo, Carolina Aloisio, Marcela R Longhi, Gladys Granero
We propose an in vitro permeability assay by using a modified lipid membrane to predict the in vivo intestinal passive permeability of drugs. Two conditions were tested, one with a gradient pH (pH 5.5 donor/pH 7.4 receptor) and the other with an iso-pH 7.4. The predictability of the method was established by correlating the obtained apparent intestinal permeability coefficients (P app ) and the oral dose fraction absorbed in humans (f a ) of 16 drugs with different absorption properties. The P app values correlated well with the absorption rates under the two conditions, and the method showed high predictability and good reproducibility...
February 15, 2018: AAPS PharmSciTech
https://www.readbyqxmd.com/read/29450806/dissolution-and-oral-bioavailability-enhancement-of-praziquantel-by-solid-dispersions
#10
Yanyan Liu, Tianzi Wang, Wenya Ding, Chunliu Dong, Xiaoting Wang, Jianqing Chen, Yanhua Li
The aim of the present investigation was to enhance the solubility, dissolution, and oral bioavailability of praziquantel (PZQ), a poorly water-soluble BCS II drug (Biopharmaceutical Classification System), using a solid dispersion (SD) technique involving hydrophilic copolymers. The SD formulations were prepared by a solvent evaporation method with PZQ and PEG 4000 (polyethylene glycol 4000), PEG 6000, or P 188 polymers at various weight ratios or a combination of PEG 4000/P 188. The optimized SD formulation, which had the highest solubility in distilled water, was further characterized by its surface morphology, crystallinity, and dissolution in 0...
February 15, 2018: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/29444996/a-model-of-analysis-in-analytical-methodology-for-biopharmaceutical-quality-control
#11
Cleyton Andrade, Miguel de la O Herrera, Elezer Lemes
One key quality control parameter for biopharmaceutical products is the analysis of residual cellular DNA (rcDNA). To determine small amounts of DNA (around 100pg) that may be in a biologically-derived drug substance, an analytical method should be sensitive, robust, reliable and accurate. In principle, three techniques have the ability to measure rcDNA: radioactive dot-blot a type of Hybridization; Threshold and quantitative Polymerase Chain Reaction (qPCR). Quality Risk Management (QRM) is a systematic process for evaluating, controlling and reporting of risks which may affects method capabilities and supports a scientific and practical approach to decision making...
February 14, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29444992/microbiological-control-for-affinity-capture-chromatography-processing-an-industry-perspective
#12
Marie Murphy, Brian Bell, James Moshi, Robert Grassi, Ren-Yo Forng, Angel Salaman, Petra Wawra Jordi, Simin Zaidi, Marcella Goodnight, Kim McFarland, Diane Hardy, Michael Knight, Mousumi Paul, Andreas Keller, Bill Carpenter, Donal McLaughlin, Una Hearty, Jose Marrero, David Bain, Derek Willison-Parry
The purpose of this paper is to provide a summary of a BPOG-led industry survey of the microbiological control aspects of affinity chromatography processing in the biopharmaceutical industry. The document provides a summary of historical microbiological control concerns, coupled with industry-derived best practices for material, equipment, and storage controls required to mitigate the potential for microbial ingress and contamination of chromatography resin and equipment. These best practice guidelines, which are derived from the members of the BPOG Bioburden Working Group, are intended to assist biopharmaceutical manufacturers enhance microbial control and monitoring strategies for chromatography systems...
February 14, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29443902/repurposing-plant-virus-nanoparticles
#13
REVIEW
Kathleen L Hefferon
Plants have been explored for many years as inexpensive and versatile platforms for the generation of vaccines and other biopharmaceuticals. Plant viruses have also been engineered to either express subunit vaccines or act as epitope presentation systems. Both icosahedral and helical, filamentous-shaped plant viruses have been used for these purposes. More recently, plant viruses have been utilized as nanoparticles to transport drugs and active molecules into cancer cells. The following review describes the use of both icosahedral and helical plant viruses in a variety of new functions against cancer...
February 14, 2018: Vaccines
https://www.readbyqxmd.com/read/29439861/enhancement-of-glycosylation-by-stable-co-expression-of-two-sialylation-related-enzymes-on-chinese-hamster-ovary-cells
#14
Nguyen Thi Sam, Ryo Misaki, Takao Ohashi, Kazuhito Fujiyama
Sialic acid plays important roles in stabilization and modulation of the interaction of molecules and membranes in organisms. Due to its high electronegativity, sialic acid can promote binding effects of molecules and support the transportation of drugs and ions in cells. This also strengthens cells against degradation from glycosidases and proteases. Hence sialic acid helps glycoproteins extend their half-lives and bioactivity. On the other hand, Chinese hamster ovary (CHO) cells have been widely used as a workhorse in biopharmaceutical fields in part due to the similarity between their glycan properties and those in humans...
February 10, 2018: Journal of Bioscience and Bioengineering
https://www.readbyqxmd.com/read/29439680/microtiter-miniature-shaken-bioreactor-system-as-a-scale-down-model-for-process-development-of-production-of-therapeutic-alpha-interferon2b-by-recombinant-escherichia-coli
#15
Joo Shun Tan, Sahar Abbasiliasi, Saeid Kadkhodaei, Yew Joon Tam, Teck-Kim Tang, Yee-Ying Lee, Arbakariya B Ariff
BACKGROUND: Demand for high-throughput bioprocessing has dramatically increased especially in the biopharmaceutical industry because the technologies are of vital importance to process optimization and media development. This can be efficiently boosted by using microtiter plate (MTP) cultivation setup embedded into an automated liquid-handling system. The objective of this study was to establish an automated microscale method for upstream and downstream bioprocessing of α-IFN2b production by recombinant Escherichia coli...
January 4, 2018: BMC Microbiology
https://www.readbyqxmd.com/read/29433310/quantifying-the-average-number-of-nucleic-acid-therapeutics-per-nanocarrier-by-single-particle-tracking-microscopy
#16
Elisa Zagato, Lotte Vermeulen, Heleen Dewitte, Griet Van Imschoot, Roosmarijn E Vandenbroucke, Jo Demeester, Stefaan C De Schmedt, Kristiaan Neyts, Katrien Remaut, Kevin Braeckmans
Nucleic acid biopharmaceuticals are being investigated as potential therapeutics. They need to be incorporated into a bio-compatible carrier so as to overcome several biological barriers. Rational development of suitable nanocarriers requires high quality characterization techniques. While size, concentration and stability can be very well measured these days, even in complex biological fluids, a method to accurately quantify the number of nucleic acid therapeutics encapsulated in nanocarriers is still missing...
February 12, 2018: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/29432762/synthesis-of-a-glibenclamide-cocrystal-full-spectroscopic-and-thermal-characterization
#17
Silvério Ferreira Silva Filho, Andreia Cardoso Pereira, Jorge M G Sarraguça, Mafalda C Sarraguça, João Lopes, Pedro Freitas Filho, Adenilson Oliveira Dos Santos, Paulo Roberto da Silva Ribeiro
A cocrystal of glibenclamide (GLB), an antidiabetic drug classified as type II compound according to the Biopharmaceutics Classification System (BCS), has been synthesised using tromethamine (TRIS) as coformer in 1:1 molar ratio, by slow solvent evaporation cocrystalization. The cocrystal obtained was characterized by X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), Raman, mid infrared (MIR), and near-infrared (NIR) spectroscopy. The results consistently show the formation of a cocrystal between API and conformer with the synthons corresponding to hydrogen bonding between hydrogen in amines of tromethamine and carbonyl and sulfonyl groups in glibenclamide...
February 9, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29430629/recent-advances-and-development-in-epidermal-and-dermal-drug-deposition-enhancement-technology
#18
Babar Iqbal, Javed Ali, Sanjula Baboota
Skin is the largest and easily accessible organ of the body. Increases in incidences of dermatological disorders, demand for drug targeting, and patient compliance have increased the popularity of topical drug delivery amongst the people. However, drug delivery across the skin is still a challenge for researchers because permeation of maximum drugs is hindered by the upper layer of the epidermis (stratum corneum). Several approaches like use of chemical permeation enhancers and physical methods such as sonophoresis, iontophoresis, electroporation, microneedles, etc...
February 12, 2018: International Journal of Dermatology
https://www.readbyqxmd.com/read/29430600/the-nistmab-reference-material-8671-lifecycle-management-and-quality-plan
#19
John E Schiel, Abigail Turner
Comprehensive analysis of monoclonal antibody therapeutics involves an ever expanding cadre of technologies. Lifecycle-appropriate application of current and emerging techniques requires rigorous testing followed by discussion between industry and regulators in a pre-competitive space, an effort that may be facilitated by a widely available test metric. Biopharmaceutical quality materials, however, are often difficult to access and/or are protected by intellectual property rights. The NISTmAb, humanized IgG1κ Reference Material 8671 (RM 8671), has been established with the intent of filling that void...
February 12, 2018: Analytical and Bioanalytical Chemistry
https://www.readbyqxmd.com/read/29430179/sodium-deoxycholate-decorated-zein-nanoparticles-for-a-stable-colloidal-drug-delivery-system
#20
Agnese Gagliardi, Donatella Paolino, Michelangelo Iannone, Ernesto Palma, Massimo Fresta, Donato Cosco
Background: The use of biopolymers is increasing in drug delivery, thanks to the peculiar properties of these compounds such as their biodegradability, availability, and the possibility of modulating their physico-chemical characteristics. In particular, protein-based systems such as albumin are able to interact with many active compounds, modulating their biopharmaceutical properties. Zein is a protein of 20-40 kDa made up of many hydrophobic amino acids, generally regarded as safe (GRAS) and used as a coating material...
2018: International Journal of Nanomedicine
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