Poster program

701. Description of the Polysorbates (Polysorbate 80 and Polysorbate 20) used as non-ionic Detergent in Solvent/Detergent Procedure for Virus Inactivation and in Formulation of Plasma Derivatives Products
Muriel Roche SEPPIC Paris
702. Safeguarding the Biomanufacturing Supply Chain: Practical Steps to Manage Raw Material and Process Risks in the Plasma Industry
Elles Steensma*Security of Supply Program Leader GE Healthcare Uppsala, Sweden
703. Challenges of Implementing Virus Filtration into Continuous Manufacturing
Daniel Strauss*, Julie Kozaili, Sarah Johnson, Scott Lute, Kurt Brorson, Naokatsu Hirotomi Asahi Kasei Bioprocess America, Glenview, IL, USA CDER, FDA, Silver Spring, MD, USA
704. Effect of Plasma Freeze Time, Thaw Time, and Hold Time on Cryosupernatant Concentrations of Plasma Proteins
Patrick Gavit (1)*, Laureano Camacho (2), John McVey (2), Alfred Weber (3) Orysya Bednarska (1) Mansi Narula (4) Chuck Borders (2) Ursula Mais-Paul (3) 1) Manufacturing Sciences, Takeda Pharmaceutical Company Limited, Los Angeles, CA, USA; 2) Regulatory Affairs and Quality, Takeda Pharmaceutical Company Limited, Bannockburn IL,USA; 3) Manufacturing Sciences, Takeda Pharmaceutical Company Limited, Vienna, Austria. 4) Department of Pediatrics-Stem Cell Transplantation at Stanford University, Palo Alto, CA, USA
705. Separation of Antibodies using Fc-???? Receptor based Affinity Column
Leila Ghaleh1, Patrick Endres2, Toru Tanaka3, Werner Conze*2, Egbert Müller2 1 University of Darmstadt, Darmstadt, Germany | 2 Tosoh Bioscience GmbH, Griesheim, Germany | 3 Tosoh Corporation, Shin-Nanyo, Japan
706. Purification of Recombinant IgM with Tailored Anion Exchangers
Carsten Voss Bio-Rad Laboratories GmbH, Munich, Germany
707. A Simple Static Cleaning Procedure for SPTFF
Torsten Bisschop, Manuel Brantner* Merck, Vienna, Austria
708. Evaluation of Chromatographic Methods on Immunoglobulin Purification
Josephine Cheng Merck Ltd.
709. Replacement of Triton X-100 by Polysorbate 20 for Manufacturing of Anti-D (Rophylac)
Matthias Spiess*, Adrian Alder, Jeannette Erne, Ibrahim El Menyawi CSL Behring AG | Wankdorfstrasse 10 | 3000 Bern 22 | Switzerland
710. Extent of Mass Capture, Protease activation and Characterization
Marcus von Nordheim*, Ibrahim El Menyawi CSL Behring, Bern, Switzerland
711. Impurity Profile and Impurity Profile-based Comparability Evaluation at CSL Behring
Nyffenegger Tanja*, von Känel Madlene, Boos Stefan CSL Behring AG, Bern, Switzerland
712. Alcohol Determination in Plasma Fractionation Intermediates by Steam Distillation and Digital Refractometry713.
Heinz Anderle*, Matthias Spork, David Horn, Theresa Bauer, Lucia Gnauer, Alfred Weber Baxalta Innovations GmbH, a Takeda company, Industriestrasse 67, A-1221 Wien/Vienna, Austria
713. Characterization and Calibration of Cohn Fractionation Intermediates by Kjeldahl Digestion and Digital Refractometry714.
Sandra Pichler, Karin Herbinger, Heinz Anderle*, Lucia Gnauer, Alfred Weber Baxalta Innovations GmbH, a Takeda company, Industriestrasse 67, A-1221 Wien/Vienna, Austria
714. Efficient Downstream Buffer Filtration with a one-fits-all Bioburden Reduction Polyethersulphone Platform Filter
Andrea Schneider, Jens Meyer, Lukas Lampe*, Max Günther Müller, Mathias Siebner Sartorius Stedim Biotech GmbH, August-Spindler-Str. 11, D-37079 Goettingen, Germany
715. Sterile Filter Optimization and Large Scale Implementation close to the point of Final Filling for 10% and 20% Polyvalent Immunoglobulin
Jean-Louis Belot, Geert Lissens*, Richard Schicho, Christophe Carnewal Sartorius Stedim Biotech GmbH, August-Spindler-Str. 11, D-37079 Goettingen, Germany Shire (Takeda), Boulevard René Branquart, B-807860 Lessines, Belgium
716. Adsorptive Pre-filtration to Increase Virus Filter Performance and Overall Process Robustness in Blood Derived Processes
Volkmar Thom, Björn Hansmann, Jörg Hosch, Benjamin Schneider* Sartorius-Stedim Biotech GmbH, Göttingen, Germany, Membrane R&D
717. Virus Removal Nanofiltration of Intravenous Immunoglobulin Using Nanocellulose-based Filter Paper
Lulu Wu, Levon Manukyan, Athanasios Mantas, and Albert Mihranyan Nanotechnology and Functional Materials, Department of Engineering Sciences, Uppsala University, Box 534, 751 21 Uppsala, Sweden
718. Virus Removal Nanofiltration of Factor IX-rich Prothrombin Complex Concentrate Using Nanocellulose-based Filter Paper
Levon Manukyan1*, Athanasios Mantas1, Mikhail Razumikhin2, Andrey Katalevsky3, Eugen Golubev4, and Albert Mihranyan1 1. Nanotechnology and Functional Materials, Department of Engineering Sciences, Uppsala University, Box 534, 751 21 Uppsala, Sweden 2. Nacimbio JC, 10, 2nd Volkonsky lane, 127473 Moscow, Russian Federation 3. Biopharmgarant LLC, Stancionnaya 45, 600901 Vladimir, Russian Federation 4. National Research Center for Hematology, Novyi Zykovskiy proezd 4, 125167 Moscow, Russian Federation
719. New Tool for IgG, IgG Subclasses and Total Protein Characterization in Biopharmaceutical Process Intermediates and Finished Products.
Gabriele Berti * , Marta Muzzi, Ginevra Bellucci, Stefano Bovani. Analytical Development Department, Kedrion Biopharma, Via di Fondovalle, 55027 Gallicano (LU), Italy.
720. A Data Analytical Approach to Investigate out of Specification Results during Coagulation Factor Purification; a Case Study in the use of Umetrics® Suite, MODDE® and SIMCA®721.
Touw, K.M.* # Johansson, E. # Lloyd, J. $ Feldman, P.A. $ # Sartorius Stedim Data Analytics AB, SE-215 33 Malmö, Sweden $ Bio Products Laboratory Limited, Elstree, WD6 3BX, United Kingdom
721. Robustness Study for Virus Retentive Filtration of Plasma Derivates
Birte Kleindienst*, Dr. Benjamin Schneider Sartorius Stedim Biotech GmbH, August-Spindler-Str. 11, D-37079 Goettingen
722. Scale-Down-Model (SDM): Advantages and Limitations
Miloš Komenda*, Ibrahim El Menyawi Research and Development, CSL Behring AG, Berne, Switzerland
723. Adoption of Single-Use Technology for the Mixing and Holding of a Stabilizer Solution for the Formulation of Plasma Derived Protein
Mathias Taillebois*, Geert Lissens Sartorius Stedim Biotech GmbH, August-Spindler-Str. 11, D-37079 Goettingen, Germany
724. Inline Buffer Preparation—Scalability from ÄKTA™ avant to Inline Conditioning
Karolina Busson*, Jenny Dunker, Enrique Carredano, Therese Westman GE Healthcare Bio-Sciences AB, SE-75184 Uppsala, Sweden
725. Magnetic Chromatography in Plasma Application
Sandeep Kristiansson*, Martin Hall, Anna Mattsson and Maria Ersoy GE Healthcare Bio-Sciences AB, SE-75184 Uppsala, Sweden
726. The Cohn Fractionation Process: an Extended Characterization
Stefano Crotti*, Luca Toti, Alessandro Crudeli, Stefano Bovani, Alessandro Gringeri, Anna Falbo Kedrion Biopharma, Via di Fondovalle, 55027, Loc. Bolognana - Gallicano (LU), Italy
727. Overcoming the Difficulty of Packing a Large Scale Chromatography Column
John Lontos* and Joseph Bertolini CSL Behring, Melbourne, Australia
728. Custom Affinity Purification Solutions
Ingeborg van Gemeren*(1), Pim Hermans(1), Jing Zhu(2), Orjana Terova(2), Andy Tomlinson(2) (1) Thermo Fisher Scientific, J.H. Oortweg 21, Leiden, The Netherlands and (2) Thermo Fisher Scientific, 35 Wiggins Ave, Bedford MA, USA
729. Characterization of Zika-, Chikungunya- & Mayaro-Virus by Virus Filtration
Elke Kederer*, Sebastian B. Teitz, Tomoyuki Miyabayashi - Asahi Kasei Bioprocess, Germany-Japan, Johannes Bluemel, Constanze Yue, Klaus Boller, Sally Baylis - Paul Ehrlich Institute Langen, Germany
730. Technology Transfer of a Privigen Scale-Down Model
Birgit Unterweger *#, Ayse Kara #, Norm Mancuso, Robert Forrest CSL Behring, 189-209 Camp Road, Broadmeadows, Victoria, 3047, Australia
731. cTRAC, cell Tolerant Radial Affinity Chromatography
Bas Stevens [1] Hans May [1], Marcel Raedts [1,2] [1] Proxcys b.v. [2] Downstream Biosystems b.v.
732. A Decade of HP-RFC Developments Flourishing into an Array of Surprising Applications
Anita Oosterveld-Janssen [1], Marcel Raedts [1,2], Thijs Groenewegen [1] [1] Proxcys b.v. [2] Downstream Biosystems b.v.,Amsterdam, The Netherlands
733. Albuminex: Continuing the Product & Process Lifecycle
Robin Turnbull, Anna Hull Bio Products Laboratory Ltd, Dagger Lane, Elstree, UK, WD6 3BX.
734. Addressing Handling Challenges of Chemicals by Granulation
Balu Guduri*, Corinna Merkel, Dennis Binder, Aline Zimmer Merck KGaA, Darmstadt, Germany
735. Improvement of an Albumin Diafiltration Process and a Step toward Continuous Processing
Alexander Helling, Martin Leuthold*, Peter Schmidt, and Geert Lissens Sartorius Stedim Biotech GmbH, Goettingen, Germany
736. Blockmaster(TM) - A Simple Approach to Improve Micro-Assay Methods
Sara Peeters [1,*], Takase Katsuyuki [2], Iinuma Ryousuke [3], James M. Van Alstine [4], [1] JSR Life Sciences, Leuven, Belgium, *sara.peeters@jsrmicro.be; [2] JSR Corporation, Tokyo, Japan; [3] JSR Research Laboratories, Tsukuba, Japan; [4] JMVA Biotech AB, Stockholm, 112 54, Sweden