The Promise of Science Lyophilizedbeta.rodpub.com/uploads/482349baxter-lyocenter-factsheet.pdf•...
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BioPharma Solutions’ Bloomington, Indiana, USA facility is home to scientists with expertise in parenteral product formulation, process and analytical development. • Four research freeze-dryers for development and optimization of freeze-dry cycles for future clinical and commercial manufacture • Modulated DSC, TGA, FTIR • TA Thermal Activity monitor (TAM) • Freeze-dry microscopy • KF and NIR for moisture analysis • Tunable Diode Laser Absorption Spectroscopy (TDLAS) • Access to XRD • Wyatt’s Multi-angle Light Scattering (MALS) Detector and RI Detector – For quantitation and characterization of soluble aggregates • Wyatt’s Eclipse Asymmetrical Field Flow Fractionation System (aFFF) – For insoluble aggregates • Brightwell’s Micro Flow Imaging (MFI) System • Convergent Biosystems’ Imaging Capillary Electrophoresis (ICE) system • Agilent’s Ultra Trap and Time-of-Flight (TOF) Mass Spectrometers (LC-MS), both equipped with APCI and ESI Sources • UPLC, HPLC, GC, Particle Size, and Bioanalytical Methods Emphasis on scientifically-driven formulation and cycle development Baxter’s Lyophilization Center of Excellence Protein Analysis The Promise of Science Lyophilized State-of-the-Art Equipment State-of-the-Art Technology Freeze dry microscopy to measure collapse
Transcript of The Promise of Science Lyophilizedbeta.rodpub.com/uploads/482349baxter-lyocenter-factsheet.pdf•...
BioPharma Solutions’ Bloomington, Indiana, USA facility is home to scientists with expertise in parenteral product formulation, process and analytical development.
• Four research freeze-dryers for development and optimization of freeze-dry cycles for future clinical and commercial manufacture • Modulated DSC, TGA, FTIR
• TA Thermal Activity monitor (TAM)
• Freeze-dry microscopy
• KF and NIR for moisture analysis
• Tunable Diode Laser Absorption Spectroscopy (TDLAS)
• Access to XRD
• Wyatt’s Multi-angle Light Scattering (MALS) Detector and RI Detector
– For quantitation and characterization of soluble aggregates
• Wyatt’s Eclipse Asymmetrical Field Flow Fractionation System (aFFF)
– For insoluble aggregates
• Brightwell’s Micro Flow Imaging (MFI) System
• Convergent Biosystems’ Imaging Capillary Electrophoresis (ICE) system
• Agilent’s Ultra Trap and Time-of-Flight (TOF) Mass Spectrometers (LC-MS), both equipped with APCI and ESI Sources
• UPLC, HPLC, GC, Particle Size, and Bioanalytical Methods
Emphasis on scientifically-drivenformulation and cycle development
Baxter’s Lyophilization Center of Excellence
Protein Analysis
The Promise of ScienceLyophilized
State-of-the-Art Equipment
State-of-the-Art Technology
Freeze dry microscopy to measure collapse
Ms. Wendy Saffell-ClemmerDirector(812) [email protected]
Dr. Steven NailPrinciple Scientist(812) [email protected]
For further information, visit: baxterbiopharmasolutions.com or contact:
• Targeted lab-to-product correlation for optimum manufacturing/cost efficiencies
• Robotic loading/unloading of lyophilizers to minimize handling and microbial exposure
• Expertise and innovative solutions to overcome protein aggregation stability problems
• Proven scientific approach to cycle development vs. traditional trial-and-error techniques
• State-of-the-art analytical methodologies for protein biophysical characterization and measurement of protein aggregates
• Expertise in capillary electrophoresis, including cIEF and cGE
Baxter is a registered trademark of Baxter International Inc.LyoStar is a trademark of SP Industries.Eclipse is a trademark of Wyatt Technology Corporation.Micro-Flow Imaging is a trademark of Brightwell Technologies Inc.© 2011 Copyright Baxter Healthcare Corporation. All rights reserved. 920802-00
Baxter’s Lyophilization Center of Excellence
cGMP Compliant Laboratory About Our Scientific Team• Published 120+ articles/presentations in the past five years
• Developed and optimized lyophilization formulations and cycles for 35+ clients
• Award-winning and industry recognized
– Recipient of the 2007 AAPS Pharm Tech Section Research Achievement Award: Dr. Steven Nail
– Two AAPS Fellows: Dr. Steven Nail and Dr. Michael Akers
– Professors of international parenteral science and technology courses: Dr. Steven Nail, Dr. Michael Akers, Gregory A. Sacha, Lisa Hardwick
– Author of “Parenterals” chapter in Remington’s: The Science and Practice of Pharmacy:
Dr. Michael Akers
– Former college of pharmacy professors, currently adjunct professors: Dr. Steven Nail and Dr. Michael Akers
– Editors and authors of Development and Manufacture of Protein Pharmaceuticals:
Dr. Steven Nail and Dr. Michael Akers
– Author of three editions of Parenteral Quality Control: Dr. Michael Akers
– Author of Sterile Drug Products book published Fall 2010: Dr. Michael Akers
• SOPs on GDP, Conduct of Studies, Significant Figures, Reference Standards, Archiving
• SOPs governing Method Validation, Method Transfers, and Investigation of Failed Acceptance Criteria
• Regular internal and external QA audits
• Laboratory instruments under Equipment Management SOP
