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Full-Text Articles in Engineering

Single Use Droplet Based Microfluidics – Screening Tools For Biotechnology And Life-Sciences, Alexander Groß, Jialan Cao, Stefen Schneider, J.M. Köhler, Thomas Henkel, Martin Roth, Mark Kielpinsky, Alexander Mendel May 2017

Single Use Droplet Based Microfluidics – Screening Tools For Biotechnology And Life-Sciences, Alexander Groß, Jialan Cao, Stefen Schneider, J.M. Köhler, Thomas Henkel, Martin Roth, Mark Kielpinsky, Alexander Mendel

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

In the recent years droplet-based microfluidic techniques were developed and used for various screening purposes mainly in the field of life-sciences and biotechnology. Therefore, droplet volumes in a range from pL to μL were used and different technology platforms were necessary to produce the required fluidic devices which made of various materials. Traditionally, lithography combined with etching processes were used to produce precise glass or silicon devices. But, hot embossing and injection molding techniques are better suited for the production of single use devices. Recently, 3D-printing technologies are under development for the generation of individual costumes made microfluidic devices in …


Of Sut And Stainless, Manuel Carrondo May 2017

Of Sut And Stainless, Manuel Carrondo

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

No Abstract, Please Click And See The Presentation.


Protein-Specific Empirical Model Of Protein Adsorption On Surfaces, Dan Nicolau May 2017

Protein-Specific Empirical Model Of Protein Adsorption On Surfaces, Dan Nicolau

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

Predicting protein adsorption from solution to a surface is an important problem in biomedicine and related fields. Despite constant attention in the literature, it is not currently possible to predict quantitatively the amount of adsorbed protein given environment, protein and surface parameters. We present a purely empirical approach to predict protein adsorption using a linearly piecewise model with breakpoint, based on progress in the understanding and quantification of physico-chemical properties on protein molecular surfaces. This model is capable of accounting for over 90% of the variance in the data, despite the fact that the adsorption data spans over three orders …


Roll-To-Roll Pilot Line For Large-Scale Manufacturing Of Microfluidic Devices, Martin Smolka, Anja Haase, Ursula Palfinger, Dieter Nees, Ladislav Kuna, Jan Hesse, Barbara Stadlober, Sascha. Geidel, Jörg Nestler, Nikolaus Ladenhauf, Andoni Rodriguez, Florian Hasenöhrl, Martin Eibelhuber, Max Sonnleitner, Guggi Kofod, Dan Kofoed, Jan Kafka, Isbaal Ramos, Manuel W. Thesen, Mirko Lohse, Ana Ayerdi, Nerea Briz May 2017

Roll-To-Roll Pilot Line For Large-Scale Manufacturing Of Microfluidic Devices, Martin Smolka, Anja Haase, Ursula Palfinger, Dieter Nees, Ladislav Kuna, Jan Hesse, Barbara Stadlober, Sascha. Geidel, Jörg Nestler, Nikolaus Ladenhauf, Andoni Rodriguez, Florian Hasenöhrl, Martin Eibelhuber, Max Sonnleitner, Guggi Kofod, Dan Kofoed, Jan Kafka, Isbaal Ramos, Manuel W. Thesen, Mirko Lohse, Ana Ayerdi, Nerea Briz

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

Roll-to-roll (R2R) technologies with roller-based nanoimprinting methods enable manufacturing of highly cost-effective and large-scale sheets of flexible polymer film with precise structures on a micro- and nanoscale 1. Areas that can benefit strongly from such large scale technologies are microfluidics, biosensors, and lab-on-chip products for point of care diagnostics, drug discovery and food control. Here, R2R fabrication could greatly reduce production costs and increase manufacturing capacity with respect to currently used products. A pilot line with this technology is investigated in the European Horizon 2020 project R2R Biofluidics and its capabilities are tested on two Demonstrators: - Demonstrator 1: In-vitro …


On The “Fate Of Leachables” In Biopharmaceutical Up-Stream And Down- Stream Processes, Armin Hauk, Ina Pahl, Roberto Menzel, Samuel Dorey, Isabelle Uettwiller May 2017

On The “Fate Of Leachables” In Biopharmaceutical Up-Stream And Down- Stream Processes, Armin Hauk, Ina Pahl, Roberto Menzel, Samuel Dorey, Isabelle Uettwiller

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

Single use systems (SUS), based on polymeric materials, are widely used in the biopharmaceutical manufacturing. Compounds potentially migrating from the polymeric materials into the production process at various stages as leachables can either negatively influence the production process performance (e.g. inhibit cell growth) or can contribute to process related drug impurities, which may potentially have an effect on product quality and/or patient safety. Today, the concept of investigating leachables is mainly focused on the measurement of extractables under worst case- or simulation-conditions plus their assessment including an interpolation towards potential leachables. In particular, in the frame of this assessment of …


Tie Layer Technology For Multilayer Coextrusion Of Single-Use Biopharma Bags, Barry A. Morris May 2017

Tie Layer Technology For Multilayer Coextrusion Of Single-Use Biopharma Bags, Barry A. Morris

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

The needs of the demanding biopharma processing bag, such as barrier, toughness and heat sealability, cannot be met by any one polymer. As a result, multiple layers of different polymers, each playing its role in meeting the design requirements, are combined in coextrusion or lamination. Most of the polymers used in these layers do not naturally adhere to each other in the film making or lamination process without tie layers. Tie layers are polymer resins designed to provide adhesion between specific polymers in a given film manufacturing process. In coextrusion, the polymer layers are brought together in the melt state. …


Influence Of Γ-Irradiated Biopharmaceutical Films, Samuel Dorey, Fanny Gaston, Magali Barbaroux,, Nathalie Dupuy, Sylvain R.A. Marque May 2017

Influence Of Γ-Irradiated Biopharmaceutical Films, Samuel Dorey, Fanny Gaston, Magali Barbaroux,, Nathalie Dupuy, Sylvain R.A. Marque

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

Preventing cross-contamination, saving costs and increasing configuration flexibility make the adoption of single-use technologies very attractive for the biopharmaceutical industry. The integrity and the security of bags are due to appropriate flexible and barrier polymeric materials, such as polyethylene (PE) or ethylene vinyl acetate (EVA) and polyethylene-co-vinyl alcohol (EVOH), which are barrier to water vapor and oxygen, respectively. Conventional stainless steel tanks are sterilized by steam sterilization by the end-users, whereas plastic containers are sterilized by gamma-irradiation before delivery. The major advantage of radio-sterilization is the penetration power of the γ-radiation. It is known that γ -sterilization of polyolefin based …


The Journey Of A Polymer Producer To Support Customers E&L Needs, Jerome Vachon May 2017

The Journey Of A Polymer Producer To Support Customers E&L Needs, Jerome Vachon

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

In the view of SABIC’s ambitions to grow in the Healthcare applications market, a clear understanding of customers’ challenges and problems with respect to Extractables and Leachables is crucial. In addition to ensuring high quality products and compliance with standard regulations, material suppliers must also have a deep knowledge of their product chemistries for specific healthcare applications. Responding to our customers’ needs when performing their own material toxicological assessment, SABIC has continued to develop and share deeper insights into E&L. A growing involvement of SABIC to develop a true E&L knowledge base, from Research to Marketing, has thus been taking …


Characterization Of Silicone Tubing – Effect Of Pressure And Irradiation On Tubing Diameter, Lise Tan-Sien-Hee, Csilla Kollar, Andrew Diehl, Ernie Jenness, Pietro Perrone May 2017

Characterization Of Silicone Tubing – Effect Of Pressure And Irradiation On Tubing Diameter, Lise Tan-Sien-Hee, Csilla Kollar, Andrew Diehl, Ernie Jenness, Pietro Perrone

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

A Single-Use assembly or system consists of numerous flexible components connected together via heat seals, overmolds or mechanical fasteners. The integrity (e.g. leak assurance) of such a system is dependent on the internal surface being continuously sealed and free of disconnects between the various components. The diameter of the flexible tubing during manufacture of the assemblies and the tubing expansion at operational pressures are important characteristics to know. Understanding these factors can help in the design of assemblies that maintain their integrity throughout their use at operating conditions. The aim of the study was to characterize four different tubing types …


Improving Single Use Bioreactor Design And Process Development Using The Hyperforma 5:1 S.U.B, Michael Goodwin May 2017

Improving Single Use Bioreactor Design And Process Development Using The Hyperforma 5:1 S.U.B, Michael Goodwin

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

Operating bioreactor vessels at low working volumes (high turn-down ratio) is often desirable but brings about challenges in regard to mixing, mass transfer, and process control. Research done towards optimizing cell culture has provided methods to improve performance and control when operating under these special conditions.  Impacts of enhanced energy transfer-Implementing bottom heat exchange, alternate impeller positions, and considering agitation dissipation rates.  Maximizing your platform-Taking advantage of the unique Thermo Fisher Scientific Drilled Hole Sparge design and implementing a new Cross Flow Sparge into the headspace have yielded reliable mass transfer and cell culture results from 10-2000L working …


Xdr-500 Mo—Single-Use Fermentor For Microbial Processes, Jozsef Vasi, Andreas Castan, Sandeep Kristiansson May 2017

Xdr-500 Mo—Single-Use Fermentor For Microbial Processes, Jozsef Vasi, Andreas Castan, Sandeep Kristiansson

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

Single-use bioreactors are well-established in production of biopharmaceuticals in mammalian expression systems. However, a similar technology breakthrough for microbial/yeast-based productions is still awaiting due to the unique requirements associated with such high-cell density cultivations, including high oxygen transfer capacity and efficient heat removal. Here, we present the single-use Xcellerex™ XDR-500 MO stirred-tank fermentor system specifically designed for microbial/yeast applications. The performance of the fermentor was evaluated using an E. coli fed-batch process producing a domain antibody (dAb) as a model system. The process was originally developed for a lab-scale conventional stainless steel system. This work describes the transposition and scale-up …


Particulate Contamination In Single Use Systems: Measurement Challenges, Klaus Wormuth, Fanny Gaston, Mathieu Labedan May 2017

Particulate Contamination In Single Use Systems: Measurement Challenges, Klaus Wormuth, Fanny Gaston, Mathieu Labedan

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

In conventional biopharmaceutical processes using stainless steel components, the pharmaceutical manufacturer is responsible for process cleanliness. However for single use systems, the pharmaceutical manufacturer “outsources” process cleanliness to the manufacturer of the single use systems, since no rinsing or cleaning occurs prior to implementation. Especially critical applications such as final fill and finish or aseptic processes demand a high degree of cleanliness with respect to particulate contamination. Although single use component assembly occurs in carefully controlled cleanroom environments, risks arise for particulate contamination from incoming components, cutting and welding operations, and human activity during manually intensive assembly processes. While visual …


Conference Program, Ekta Mahajan, Gary Lye, Regine Eibl-Schindler May 2017

Conference Program, Ekta Mahajan, Gary Lye, Regine Eibl-Schindler

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

No abstract provided.


Effect Of Agitation On Protein Aggregation In Vials Made From Glass Or Plastics, Birgit Mueller-Chorus, Erica Tullo, Vinod Vilivalam, Lloyd Waxman May 2017

Effect Of Agitation On Protein Aggregation In Vials Made From Glass Or Plastics, Birgit Mueller-Chorus, Erica Tullo, Vinod Vilivalam, Lloyd Waxman

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

The increasing use of proteins as therapeutics including monoclonal antibodies has focused attention on the need to maintain the stability of these labile molecules during both storage and shipment. The degradation of therapeutic proteins can arise from aggregation and adsorption in primary containers, as well as from exposure to leachables, and chemical damage due to exposure to oxygen or light. Since vials continue to be used as primary containers for multiple-use applications, including vaccines and lyophilized drug products, we have compared the effect of mechanical stress on protein aggregation in vials made of glass versus vials made of the plastic …