Nucleic Acid Solutions Flexible Therapeutic Oligo Manufacturing & Development Services Launch of Therapeutic Oligo Development Services & Manufacturing Flexible Therapeutic Oligo Development Services & Manufacturing Agilent’s Nucleic Acid Solutions Division provides the highest value for therapeutic oligonucleotide manufacturing and development via: • State-of-the-art, multi-product 33,500 sq. ft. facility in Boulder, CO with design based upon significant industry experience • World-class team with extensive expertise in high complexity therapeutic oligo manufacturing and development • Complete set of turn-key oligo development services Nucleic Acid Solutions Agilent Nucleic Acid Solutions provides much more than just manufacturing of preclinical and clinical oligonucleotide materials • Turn-key solutions encompassing all oligo development activities enables customers to initiate or progress through clinical trials more quickly Analytical Services/QC Analytical Development • Enables companies to fully outsource oligo manufacturing and development activities in order to focus on core competencies Manufacturing Process Development Quality Assurance Project Management Customer Agilent’s Nucleic Acid Solutions Capabilities include: Full Spectrum of Analytical Method Development and Validation Capabilities: Broad Oligonucleotide Manufacturing Capabilities: • GMP production at gram to kilogram scale: • LCMS impurity profile analysis • Research through toxicology/pre-clinical studies • Process Intermediate and Final Drug Substance Characterization • Clinical trial through commercial production Therapeutic Development Services: • Multiple HPLC Chromatographic Techniques • HPLC Detection Capabilities • Process development and scale-up optimization • Gas Chromatography Mass Spectrometry Detection Capabilities • ICH stability testing and data evaluation • Transition Melt Analysis (TM) • Regulatory (CMC) submission support • Volumetric and Coulometric Water Determination • Process impurity trouble-shooting • Osmolality • Process validation • Endotoxin Analysis • Technology transfer • Binding Assays • Metals Analysis by ICP-MS Call us today to discuss your therapeutic development project with one of our project managers at 303 222 4900 • Ultra Violet Spectroscopy (UV) • Nuclear Magnetic Resonance (NMR) • Total Organic Carbon Analysis (TOC) • Fourier Transform Infrared Spectroscopy (FTIR) QA/GMP Experienced Quality Staff: • Ion Chromatography • FDA audits • Capillary Electrophoresis • Validation • Wet Chemistry Capabilities • Part 11 compliant document system • USP and EP Testing Research Services: • Lead optimization • Custom amidite development • Conjugation chemistry • Forced degradation studies Or email us at [email protected] Agilent Technologies, Inc. 5555 Airport Blvd. Suite 100 Boulder, CO 80301 303 222 4900 ph 303 440 0273 fax [email protected] www.agilent.com/chem/nucleicacid This information is subject to change without notice © Agilent Technologies, Inc. 2006 Printed in USA October 12, 2006 Call us today to discuss your therapeutic development project with one of our project managers at 303 222 4900 Or email [email protected] Agilent Technologies, Inc. 5555 Airport Blvd. Suite 100 Boulder, CO 80301 303 222 4900 ph 303 440 0273 fax [email protected] http://www.agilent.com/chem/nucleicacid This information is subject to change without notice © Agilent Technologies, Inc. 2006 Printed in USA October 12, 2006
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