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Klapoetke S.,KBI Biopharma | Xie M.H.,China Medicine Corporation
Journal of Pharmaceutical and Biomedical Analysis | Year: 2017

Protein-level partial reduction was investigated as a novel sample preparation technique to characterize proteins with cystine knots or complex disulfide linkages. Human Factor Xa containing twelve disulfide bonds was selected as a model protein to demonstrate this methodology. Five in twelve disulfide linkages were characterized through conventional non-reduced samples while the other seven disulfide linkages containing cystine knots were successfully characterized though partially reduced samples. Each disulfide linkage was confirmed through product ions generated by an UPLC-ESI QTOF MS system equipped with data independent collision-induced dissociation (CID) acquisition. Free cysteines in the sample were also determined in this study. © 2016 Elsevier B.V.

News Article | February 15, 2017
Site: www.marketwired.com

CARY, NC--(Marketwired - February 08, 2017) - The 2nd edition of Industry Standard Research's (ISR's) Biologic API Contract Manufacturer Quality Benchmarking report indicates that buyers of outsourced biologic API services are less loyal to the CMOs they use compared to one year ago. The report includes information on respondents' outsourcing philosophies and practices, CMO perceptions and interactions and CMO selection drivers before diving into a series of in-depth performance analyses specific to the large molecule offerings of 30 contract manufacturing organizations. 208 respondents provide rating assessments on 393 service encounters. "This year, the data showed a decrease in the industry average for CMO loyalty of almost one-third of a point on a ten-point scale among biologic API contract manufacturers," explained Kate Hammeke, Vice President, Market Research at Industry Standard Research. "ISR's loyalty metric is an index of overall satisfaction, likelihood to use again and willingness to recommend. Changes in these scores may be indicative of a broader decline in customer loyalty, which retail has been experiencing for a few years, or a more direct response to changes in satisfaction with service provider performance. For CMOs featured in the report, it makes sense to investigate whether the change in loyalty traces back to a specific loyalty component or whether it can be attributed to broader changes in customer behavior." The report provides a Consumer Reports-style analysis where each of the 30 CMOs included in the research is evaluated across 27 service quality attributes, making this report the most comprehensive assessment of quality in the contract manufacturing space. These performance metrics are categorized into four 'scorecards': Delivery Factors, Organization Factors, Capabilities and Staff Characteristics. From these performance evaluations, respondents indicated how well the manufacturers performed with respect to expectations specific to their experience working with the manufacturer(s). For buyers of outsourced services, the report includes highly valuable information to help guide CMO selection for large molecule projects from early clinical stages to commercialization. CMO performance attributes evaluated by respondents include Ability to manufacture biologic API, Reliable on-time delivery, Regulatory History, Quality performance metrics, Scale-up and tech transfer abilities, Scientific knowledge, Right-first-time measurements, and many others. Data include an in-depth analysis of 16 of the 30 featured contract manufacturers, including AbbVie Contract Manufacturing, Boehringer Ingelheim, Catalent, Celltrion, CMC Biologics, FujiFilm Diosynth Biotechnologies, GSK Contract Manufacturing, KBI Biopharma, Lonza, Novasep, Patheon, Pfizer CentreOne, Samsung BioLogics, Sanofi CEPiA, Therapure Biopharma and Wuxi AppTec. There are several stand-out CMOs this year. Two contract manufacturers -- Pfizer CentreOne and Sanofi CEPiA -- placed among the leaders across all of the four scorecards (Delivery, Organizational, Capabilities and Staff Characteristics). Among smaller CMOs, KBI Bio was a top performer in Delivery Factors and Staff Characteristics, while Therapure BioPharma scored well in Capabilities and Staff Characteristics. For more information on ISR's "Biologic API Contract Manufacturer Quality Benchmarking" report, please visit ISR's report page at http://www.isrreports.com/reports/biologic-api-contract-manufacturer-quality-benchmarking-2nd-edition/ Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR's off-the-shelf intelligence and custom research offerings, please visit the company's website at www.isrreports.com, email info@isrreports.com or follow ISR on Twitter @ISRreports.

News Article | May 11, 2016
Site: www.realwire.com

SMi Group reports (2016.05.11, San Diego, California, USA): FDA will provide the latest updates on Pre-Filled Syringes and Combination Products at Pre-Filled Syringes West Coast 2016. SMi are delighted to announce that FDA will be presenting at Pre-Filled Syringes West Coast this June in San Diego. Tina Kiang, Ph.D., Deputy Director, Science and Policy, and Shannon Hoste, Human Factors Engineer, FDA, will be speaking on Day One of the conference on "Safety Assessment and Regulatory Updates on Pre-Filled Syringes and Combination Products". For further information, please visit www.prefilled-syringes-westcoast.com/RealWire Don’t miss the chance in 4 weeks’ to participate in the Q&A session with FDA and meet 100+ leading drug delivery experts from the Pharmaceutical and Biotechnology businesses in the West Coast. Pre-Filled Syringes West Coast 2016 brings together key decision makers in the PFS industry from Biogen, Teva, Pfizer, Boehringer Ingelheim Fremont, Inc., Shire and many more. The two-day conference takes place in San Diego, USA, and will provide the perfect platform to discuss regulatory challenges and analyse device design to drive patient’s safety, usability and delivery excellence. Day one of the conference will address topics on regulatory developments and updates, the rise of complex combination products for PFS, and formative studies of human factor engineering. Day two explores technological advancements in manufacturing, competitiveness of products, and patient concerns. A post-conference workshop on June 8th will focus on Human Factor Engineering for Pre-Filled Syringes and Autoinjectors. Hosted by Core Human Factors, the session will cover the regulatory requirements for human factors work on medical devices, comparisons between the regulatory requirements in the US and the EMEA region, and will discuss when, and how, to go about panning human factors activities. For the full event agenda including all speakers and their topics please visit the event website on www.prefilled-syringes-westcoast.com/RealWire PFS West Coast 2016 will provide delegates with an unrivalled networking platform including a post-conference lunch sponsored by ZebraSci, Inc. The networking lunch will be held at Stone Brewing World Bistro & Gardens and includes beer flight tasting. This is the perfect opportunity to meet and discuss core issues of pre-filled syringes with industry colleagues. This offer is exclusive to the first 40 Pharma and Biotech. For more information please contact Fateja Begum on +44(0)2078276184 or e-mail fbegum@smi-online.co.uk Alongside lead sponsor ZebraSci, Inc., SMi’s Pre-Filled Syringes West Coast 2016 is proudly sponsored by Bosch Packaging Technology, DDL, KBI Biopharma, Mitsubishi Gas Chemical, Noxilizer, Steris, Terumo and Zeon. For tailored sponsorship and exhibition opportunities contact Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk. About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk

Zhang X.,Ohio State University | Zhang X.,KBI Biopharma | Yang S.-T.,Ohio State University
Journal of Biotechnology | Year: 2011

We have designed, built and tested a three-dimensional (3-D) cell culture system on modified microplates for high-throughput, real-time, proliferation and cytotoxicity assays. In this 3-D culture system, cells expressing the enhanced green fluorescent protein (EGFP) were cultured in nonwoven polyethylene terephthalate (PET) fibrous scaffolds. Compared to 2-D cultures in conventional microplates, 3-D cultures gave more than 10-fold higher fluorescence signals with significantly increased signal-to-noise ratio (SNR), thus extending the application of conventional fluorescence microplate readers for online monitoring of culture fluorescence. The 3-D system was successfully used to demonstrate the effects of fetal bovine serum, fibronectin coating of PET fibers, and cytotoxicity of dexamethasone on recombinant murine embryonic stem D3 cells. The dosage effects of 5-fluorouracil and gemcitabine on high-density colon cancer HT-29 cells were also tested. These studies demonstrated that the 3-D culture microplate system with EGFP expressing cells can be used as a high-throughput system in drug discovery and bioprocess development. © 2010 Elsevier B.V.

Robertson S.L.,University of Pittsburgh | Smedley III J.G.,University of Pittsburgh | Smedley III J.G.,KBI Biopharma | McClane B.A.,University of Pittsburgh
Infection and Immunity | Year: 2010

The 24-member claudin protein family plays a key role in maintaining the normal structure and function of epithelial tight junctions. Previous studies with fibroblast transfectants and naturally sensitive Caco-2 cells have also implicated certain claudins (e.g., Claudin-4) as receptors for Clostridium perfringens enterotoxin (CPE). The present study first provided evidence that the second extracellular loop (ECL-2) of claudins is specifically important for mediating the host cell binding and cytotoxicity of native CPE. Rat fibroblast transfectants expressing a Claudin-4 chimera, where the natural ECL-2 was replaced by ECL-2 from Claudin-2, exhibited no CPE-induced cytotoxicity. Conversely, CPE bound to, and killed, CPE-treated transfectants expressing a Claudin-2 chimera with a substituted ECL-2 from Claudin-4. Site-directed mutagenesis was then used to alter an ECL-2 residue that invariably aligns as N in claudins known to bind native CPE but as D or S in claudins that cannot bind CPE. Transfectants expressing a Claudin-4N149D mutant lost the ability to bind or respond to CPE, while transfectants expressing a Claudin-1 mutant with the corresponding ECL-2 residue changed from D to N acquired CPE binding and sensitivity. Identifying carriage of this N residue in ECL-2 as being important for native CPE binding helps to explain why only certain claudins can serve as CPE receptors. Finally, preincubating CPE with soluble recombinant Claudin-4, or Claudin-4 fragments containing ECL-2 specifically blocked the cytotoxicity on Caco-2 cells. This result opens the possibility of using receptor claudins as therapeutic decoys to ameliorate CPE-mediated intestinal disease. Copyright © 2010, American Society for Microbiology. All Rights Reserved.

Wolfe L.S.,KBI Biopharma | Barringer C.P.,KBI Biopharma | Mostafa S.S.,KBI Biopharma | Shukla A.A.,KBI Biopharma
Journal of Chromatography A | Year: 2014

The unique selectivity of mixed mode chromatography resins is driving increasing utilization of these novel selectivities into bioprocess applications. There is a need for improved fundamental understanding of protein binding to these stationary phases to enable the development of efficient and robust purification processes. A panel of four monoclonal antibodies and two model proteins were employed to characterize protein interaction with a mixed-mode chromatographic resin comprising a hydrophobic ligand with cation-exchange functionality. Binding of these proteins was studied as a function of salt concentration and pH in the presence of various mobile phase modulators. This knowledge was applied towards screening mobile phase modulators that could selectively decrease host cell protein levels during monoclonal antibody purification. © 2014 Elsevier B.V.

Shukla A.A.,KBI Biopharma | Gottschalk U.,Sartorius Stedim Biotech
Trends in Biotechnology | Year: 2013

The manufacture of protein biopharmaceuticals is conducted under current good manufacturing practice (cGMP) and involves multiple unit operations for upstream production and downstream purification. Until recently, production facilities relied on the use of relatively inflexible, hard-piped equipment including large stainless steel bioreactors and tanks to hold product intermediates and buffers. However, there is an increasing trend towards the adoption of single-use technologies across the manufacturing process. Technical advances have now made an end-to-end single-use manufacturing facility possible, but several aspects of single-use technology require further improvement and are continually evolving. This article provides a perspective on the current state-of-the-art in single-use technologies and highlights trends that will improve performance and increase the market penetration of disposable manufacturing in the future. © 2012 Elsevier Ltd.

Klapoetke S.,KBI Biopharma
Methods in Molecular Biology | Year: 2014

Three methods are introduced here to fully characterize glycosylation at protein, peptides, and glycan levels by LC-MS (ESI TOF MS). At protein level, glycosylation could be detected by comparing protein masses with and without glycan. At peptide level, glycosylation sites could be detected by removing glycan and site specific glycosylation could be examined with glycopeptides. At glycan level, glycan profiling and identification could be achieved by analyzing released glycans labeled with procainamide. All these methods are MS based and able to provide a whole picture of glycosylation of a glycoprotein. These methods are also simple to implement in industrial or academic laboratory with proper training and instruments. © 2014 Springer Science+Business Media, New York.

KBI Biopharma | Date: 2013-03-26

The present invention is directed to methods and compositions for separating and isolating target molecules. In particular, the present invention comprises devices, such as CCDs, that contain particles without the need for support structures. Chromatography separation techniques, including but not limited to, ion exchange, size separation, affinity chromatography, ion exclusion, ligand exchange, reversed phase and normal phase partitioning, are used in the CCD. Methods also include low, medium and high pressure liquid chromatography. Such methods can be used for analytical, semi-preparative processes, initial clarification, preparative filtration and process scale applications.

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