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https://www.readbyqxmd.com/read/28541681/platelet-microcapsule-hybrids-leverage-contractile-force-for-targeted-delivery-of-hemostatic-agents
#1
Caroline E Hansen, David R Myers, Wallace Hunter Baldwin, Yumiko Sakurai, Shannon L Meeks, L Andrew Lyon, Wilbur A Lam
We report a cell-mediated, targeted drug delivery system utilizing polyelectrolyte multilayer capsules that hybridize with the patient's own platelets upon intravenous administration. The hybridized platelets function as the sensor and actuator for targeted drug delivery and controlled release in our system. These capsules are biochemically and mechanically tuned to enable platelet adhesion and capsule rupture upon platelet activation and contraction, enabling the targeted and controlled "burst" release of an encapsulated biotherapeutic...
May 25, 2017: ACS Nano
https://www.readbyqxmd.com/read/28539564/improvement-of-local-cell-delivery-using-helix-transendocardial-delivery-catheter-in-a-porcine-heart
#2
Yoshiaki Mitsutake, Wook Bum Pyun, Didier Rouy, Cheryl Wong Po Foo, Simon H Stertzer, Peter Altman, Fumiaki Ikeno
Cardiac regeneration strategies using stem cells have shown variable and inconsistent results with respect to patient cardiac function and clinical outcomes. There has been increasing consensus that improving the efficiency of delivery may improve results. The Helix transendocardial delivery system (BioCardia Inc.) has been developed to enable percutaneous transendocardial biotherapeutic delivery. Therefore, we evaluated cell retention using this unique system compared with direct transepicardial injection and intracoronary infusion in an animal model...
May 23, 2017: International Heart Journal
https://www.readbyqxmd.com/read/28536452/exploring-the-trails-less-travelled-trail-in-cancer-biology-and-therapy
#3
REVIEW
Silvia von Karstedt, Antonella Montinaro, Henning Walczak
The discovery that the tumour necrosis factor-related apoptosis-inducing ligand (TRAIL) can induce apoptosis of cancer cells without causing toxicity in mice has led to the in-depth study of pro-apoptotic TRAIL receptor (TRAIL-R) signalling and the development of biotherapeutic drug candidates that activate TRAIL-Rs. The outcome of clinical trials with these TRAIL-R agonists has, however, been disappointing so far. Recent evidence indicates that many cancers, in addition to being TRAIL resistant, use the endogenous TRAIL-TRAIL-R system to their own advantage...
May 24, 2017: Nature Reviews. Cancer
https://www.readbyqxmd.com/read/28528575/characterization-of-a-cyclic-olefin-polymer-microcentrifuge-tube
#4
Lloyd Waxman, Rachel L Erwin, Vinod D Vilivalam
Here, we describe the properties of a prototype microcentrifuge tube made from the plastic cyclic olefin polymer (COP). This material has been used in the manufacture of primary containers including syringes and vials for the storage, shipment, and delivery of biotherapeutics, vaccines, and cell therapy products. Its low level of extractable substances and metals along with its glass-like clarity make COP an attractive material for the fabrication of microcentrifuge tubes and other consumable laboratory plasticware where contamination is an important consideration, such as in the storage and analysis of labile proteins, nucleic acids, and metabolites...
May 1, 2017: BioTechniques
https://www.readbyqxmd.com/read/28526733/discovery-and-optimization-of-hkt288-a-cadherin-6-targeting-adc-for-the-treatment-of-ovarian-and-renal-cancer
#5
Carl U Bialucha, Scott D Collins, Xiao Li, Parmita Saxena, Xiamei Zhang, Clemens Dürr, Bruno LaFont, Pierric Prieur, Yeonju Shim, Rebecca Mosher, David Lee, Lance Ostrom, Tiancen Hu, Sanela Bilic, Ivana Liric Rajlic, Vladimir Capka, Wei Jiang, Joel P Wagner, GiNell Elliott, Artur Veloso, Jessica C Piel, Meghan M Flaherty, Keith G Mansfield, Emily K Meseck, Tina Rubic-Schneider, Anne Serdakowski London, William R Tschantz, Markus Kurz, Duc Nguyen, Aaron Bourret, Matthew J Meyer, Jason E Faris, Mary J Janatpour, Vivien W Chan, Nicholas C Yoder, Kalli C Catcott, Molly A McShea, Xiuxia Sun, Hui Gao, Juliet Williams, Francesco Hofmann, Jeffrey A Engelman, Seth A Ettenberg, William R Sellers, Emma Lees
Despite an improving therapeutic landscape, significant challenges remain in treating the majority of advanced ovarian and renal cancer patients. We identified the cell-cell adhesion molecule cadherin-6 (CDH6) as a lineage gene having significant differential expression in ovarian and kidney cancer. HKT288 is an optimized CDH6-targeting DM4-based antibody drug conjugate (ADC) developed for the treatment of these diseases. Our study provides mechanistic evidence supporting the importance of linker choice for optimal anti-tumor activity and highlights CDH6 as a novel antigen for biotherapeutic development...
May 19, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28526278/biotherapeutics-in-chronic-rhinosinusitis-with-and-without-nasal-polyps
#6
Claus Bachert, Philippe Gevaert, Peter Hellings
In western countries, 85% of chronic rhinosinusitis with nasal polyp disease reveals a type 2 inflammatory pattern with expression of IL-4, -5, and -13 as well as increased concentrations of IgE, whereas chronic rhinosinusitis without nasal polyps merely expresses these biomarkers. The degree of type 2 inflammation furthermore is associated with disease severity, asthma comorbidity, and recurrence of disease after surgery. Therefore, these biomarkers also form the targets for innovative therapeutic approaches such as monoclonal antibodies directed against IgE, IL-5, and IL-4 receptor alpha, blocking the activity of IL-4 and -13...
May 16, 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/28509534/analysis-of-three-epoetin-alpha-products-by-lc-and-lc-ms-indicates-differences-in-glycosylation-critical-quality-attributes-including-sialic-acid-content
#7
Rebecca I Thomson, Richard Andrew Gardner, Katja Strohfeldt, Daryl L Fernandes, Graham Philip Stafford, Daniel I R Spencer, Helen M I Osborn
Erythropoietin (EPO) is one of the main treatments for anaemic patients, greatly improving their quality of life. In this study, biosimilars Binocrit and a development product, called here CIGB-EPO, were compared to the originator product, Eprex. All three are epoetin alpha products, reputed to have similar glycosylation profiles. The quality, safety and efficacy of this biotherapeutic depend on the following glycosylation critical quality attributes (GCQAs): sialylation, N-glycolyl-neuraminic acid (Neu5Gc) content, branching, N-acetyl-lactosamine (LacNAc) extensions and, arguably, O-acetylation pattern...
May 16, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28493135/characterization-of-host-cell-proteins-hcps-in-cho-cell-bioprocesses
#8
Catherine E M Hogwood, Lesley M Chiverton, C Mark Smales
Host cell protein content during bioprocessing of biotherapeutic proteins generated from cultured Chinese hamster ovary (CHO) cells is typically measured using immunological and gel-based methods. Estimation of HCP concentration is usually undertaken using Enzyme-Linked ImmunoSorbent Assays (ELISA), while estimation of HCP clearance/presence can be achieved by comparing 2D-PAGE images of samples and by undertaking western blotting of 2D-PAGE analyzed samples. Here, we describe the analyses of HCP content using these methodologies...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28493121/glycoengineering-of-cho-cells-to-improve-product-quality
#9
Qiong Wang, Bojiao Yin, Cheng-Yu Chung, Michael J Betenbaugh
Chinese hamster ovary (CHO) cells represent the predominant platform in biopharmaceutical industry for the production of recombinant biotherapeutic proteins, especially glycoproteins. These glycoproteins include oligosaccharide or glycan attachments that represent one of the principal components dictating product quality. Especially important are the N-glycan attachments present on many recombinant glycoproteins of commercial interest. Furthermore, altering the glycan composition can be used to modulate the production quality of a recombinant biotherapeutic from CHO and other mammalian hosts...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28488883/ultrasensitive-bioanalysis-current-status-and-future-trends
#10
Stéphanie Simon, Eric Ezan
Ligand-binding techniques such as immunoassays, the reference for clinical diagnosis, offer a wide range of innovative approaches based on signal DNA amplification, nanotechnologies or digital assays, which result in technologies with sensitivities more than 1000-times that of formats used 20 years ago. Providing that these technologies gain acceptance and translate into robust commercial platforms, we expect that several fields will be impacted in the near future, including the clinical diagnosis of cancer markers, the early detection of infectious diseases and the safety of biotherapeutics...
May 10, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28488174/characterization-of-apolipoprotein-c3-apo-c3-lna-dna-impurities-and-degradation-products-by-lc-ms-ms
#11
Olga V Friese, Justin B Sperry, Yan He, Liji Joseph, James A Carroll, Jason C Rouse
Apolipoprotein C3 (Apo C3) LNA/DNA gapmer was evaluated under various stress and formulation conditions for the purpose of its development as a potential biotherapeutic for low density lipoprotein (LDL) lowering. Using ion-pairing (IP) reversed-phase (RP) liquid chromatography ultra-high resolution (UHR) tandem mass spectrometry (IP-RPLC-MS/MS), a combination of accurate mass measurements and collision-induced dissociation enabled in-depth characterization of Apo C3 LNA/DNA oligonucleotide, in particular the inherent impurities following synthesis and degradation products after exposure to stress conditions...
May 9, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28486471/model-based-analysis-of-n-glycosylation-in-chinese-hamster-ovary-cells
#12
Frederick J Krambeck, Sandra V Bennun, Mikael R Andersen, Michael J Betenbaugh
The Chinese hamster ovary (CHO) cell is the gold standard for manufacturing of glycosylated recombinant proteins for production of biotherapeutics. The similarity of its glycosylation patterns to the human versions enable the products of this cell line favorable pharmacokinetic properties and lower likelihood of causing immunogenic responses. Because glycan structures are the product of the concerted action of intracellular enzymes, it is difficult to predict a priori how the effects of genetic manipulations alter glycan structures of cells and therapeutic properties...
2017: PloS One
https://www.readbyqxmd.com/read/28475417/challenges-and-opportunities-for-the-future-of-monoclonal-antibody-development-improving-safety-assessment-and-reducing-animal-use
#13
Fiona Sewell, Kathryn Chapman, Jessica Couch, Maggie Dempster, Shawn Heidel, Lise Loberg, Curtis Maier, Tim K McLachlan, Marque Todd, Jan Willem van der Laan
The market for biotherapeutic monoclonal antibodies (mAbs) is large and is growing rapidly. However, attrition poses a significant challenge for the development of mAbs, and for biopharmaceuticals in general, with large associated costs in resource and animal use. Termination of candidate mAbs may occur due to poor translation from preclinical models to human safety. It is critical that the industry addresses this problem in order to maintain productivity. Though attrition poses a significant challenge for pharmaceuticals in general, there are specific challenges related to the development of antibody-based products...
May 5, 2017: MAbs
https://www.readbyqxmd.com/read/28454057/application-of-2d-nmr-with-room-temperature-nmr-probes-for-the-assessment-of-the-higher-order-structure-of-filgrastim
#14
Robert G Brinson, Houman Ghasriani, Derek J Hodgson, Kristie M Adams, Ian McEwen, Darón I Freedberg, Kang Chen, David A Keire, Yves Aubin, John P Marino
The higher order structure (HOS) of biotherapeutics is a critical quality attribute that can be evaluated by nuclear magnetic resonance (NMR) spectroscopy at atomic resolution. NMR spectral mapping of HOS can be used to establish HOS consistency of a biologic across manufacturing changes or to compare a biosimilar to an innovator reference product. A previous inter-laboratory study performed using filgrastim drug products demonstrated that two-dimensional (2D)-NMR (1)H(N)-(15)N(H) heteronuclear correlation spectroscopy is a highly robust and precise method for mapping the HOS of biologic drugs at natural abundance using high sensitivity NMR 'cold probes...
April 4, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28440276/next-generation-probiotics-the-spectrum-from-probiotics-to-live-biotherapeutics
#15
Paul W O'Toole, Julian R Marchesi, Colin Hill
The leading probiotics currently available to consumers are generally drawn from a narrow range of organisms. Knowledge of the gut microbiota and its constituent actors is changing this paradigm, particularly given the phylogenetic range and relatively unknown characteristics of the organisms under investigation as novel therapeutics. For this reason, and because their development is likely to be more amenable to a pharmaceutical than a food delivery route, these organisms are often operationally referred to as next-generation probiotics, a concept that overlaps with the emerging concept of live biotherapeutic products...
April 25, 2017: Nature Microbiology
https://www.readbyqxmd.com/read/28436240/biotherapeutic-potential-and-mechanisms-of-action-of-colchicine
#16
Kashyap Kumar Dubey, Punit Kumar, Nikolaos E Labrou, Pratyoosh Shukla
Cancer is a clinical situation caused by uncontrolled cell division and is responsible for a large number of deaths worldwide. Colchicine is a classical antimitotic, tubulin-binding agent (TBA) which is being explored for its antitumor activities, although its tubulin-binding ability leads to some toxicity toward normal cells proliferation. Colchicine derivatives are considered as potent antitumor compounds with less toxicity compared to colchicine. Derivatives with substituted functional groups at A-ring (methoxy), B-ring (acetamide) or C-ring (methoxy) have been synthesized via chemical and microbial routes and show modified bioactivities and altered tropolonic functionality...
April 23, 2017: Critical Reviews in Biotechnology
https://www.readbyqxmd.com/read/28435459/aptamer-internalization-via-endocytosis-inducing-s-phase-arrest-and-priming-maver-1-lymphoma-cells-for-cytarabine-chemotherapy
#17
Huan Li, Shuanghui Yang, Ge Yu, Liangfang Shen, Jia Fan, Ling Xu, Hedong Zhang, Nianxi Zhao, Zihua Zeng, Tony Hu, Jianguo Wen, Youli Zu
The goal of precision therapy is to efficiently treat cancer without side effects. Aptamers are a class of small ligands composed of single-stranded oligonucleotides that bind to their targets with high affinity and specificity. In this study, we identified an ssDNA aptamer specifically targeting Maver-1 lymphoma cells with high binding affinity (Kd = 70±8 pmol/L). Interestingly, cellular cycle studies revealed that exposure of Maver-1 cells to synthetic aptamers triggered S-phase arrest of 40% of the cells (vs...
2017: Theranostics
https://www.readbyqxmd.com/read/28425960/studying-lactoferrin-n-glycosylation
#18
REVIEW
Sercan Karav, J Bruce German, Camille Rouquié, Annabelle Le Parc, Daniela Barile
Lactoferrin is a multifunctional glycoprotein found in the milk of most mammals. In addition to its well-known role of binding iron, lactoferrin carries many important biological functions, including the promotion of cell proliferation and differentiation, and as an anti-bacterial, anti-viral, and anti-parasitic protein. These functions differ among lactoferrin homologs in mammals. Although considerable attention has been given to the many functions of lactoferrin, its primary nutritional contribution is presumed to be related to its iron-binding characteristics, whereas the role of glycosylation has been neglected...
April 20, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28421849/infliximab-crystal-structures-reveal-insights-into-self-association
#19
Thomas F Lerch, Penelope Sharpe, Stephen J Mayclin, Thomas E Edwards, Eunhee Lee, Hugh D Conlon, Sharon Polleck, Jason C Rouse, Yin Luo, Qin Zou
Aggregation and self-association in protein-based biotherapeutics are critical quality attributes that are tightly controlled by the manufacturing process. Aggregates have the potential to elicit immune reactions, including neutralizing anti-drug antibodies, which can diminish the drug's efficacy upon subsequent dosing. The structural basis of reversible self-association, a form of non-covalent aggregation in the native state, is only beginning to emerge for many biologics and is often unique to a given molecule...
April 19, 2017: MAbs
https://www.readbyqxmd.com/read/28419935/identification-of-a-host-cell-protein-impurity-in-therapeutic-protein-p1
#20
Deepti Ahluwalia, Harbhajan Dhillon, Thomas Slaney, Hangtian Song, Heather Boux, Sheetal Mehta, Lei Zhang, Anulfo Valdeza, Girija Krishnamurthy
Residual host cell proteins (HCPs) are process-related impurities present in biotherapeutics that can pose safety health risks to patients. An adequate control of HCP levels in the final product, and demonstration of HCP clearance throughout a product manufacturing process is critical for all biotherapeutic products. Developing effective downstream purification processes can be challenging as HCPs and product proteins may possess an affinity for each other or have similar physicochemical properties, resulting in co-purification...
April 9, 2017: Journal of Pharmaceutical and Biomedical Analysis
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