Switzerland EXPERTS TAKING CARE

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1 CordenPharma Switzerland EXPERTS TAKING CARE CordenPharma Switzerland Eichenweg Liestal Switzerland Phone Fax sales@cordenpharma.com

2 Our History Founded as Sygena AG focusing on lipid and amino acid chemistry Genzyme Corporation acquired Sygena AG for the GMP manufacture of APIs and high-value pharmaceutical excipients Sygena officially changed its name to Genzyme Pharmaceuticals Genzyme Pharmaceuticals acquired by ICIG to become CordenPharma Switzerland cordenpharma Switzerland CordenPharma Switzerland, located in Liestal near Basel, is a cgmp manufacturing facility with over 25 years of experience in the production of pharmaceutical ingredients including synthetic lipids, peptides, carbohydrates and other complex small molecules. CordenPharma Switzerland is additionally an industry-recognized leader in the manufacturing of amino acid derivatives and pseudoproline dipeptides suitable for the GMP production of Your CMO Partner > 25 Years of Experience peptide APIs. CordenPharma Switzerland s chemists are experts in developing and providing scalable processes, analytical controls and full DMF / IND / IMPD support for the manufacture of complex molecules. us Compliance Worldwide cgmp certification - API manufacturing and Analytical Testing US-FDA 2000, 2004, 2007, 2011 Swissmedic bi-annually - most recently April 2011, April 2013 Numerous customers from all over the world

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4 what we do Custom Manufacturing of APIs Lipids, Peptides & Carbohydrates CordenPharma Switzerland is the leader in the production of fully synthetic glycero and sphingolipids, which are highly purified single compounds produced in bulk quantities with consistent batch-to-batch quality. Used as critical formulation excipients and APIs in a number of approved parenterals and pulmonary delivered therapeutics, our lipids are available in small quantities for Research & Development. CordenPharma Switzerland is also a preferred partner for the custom manufacture of cationic lipids used in liposomal delivery of oligonucleotide-based active ingredients. Our core competencies furthermore include solution-phase and/or solid-phase peptide chemistry. With in-house development and multi-ton production capabilities for chiral building blocks, unusual and natural amino acid derivatives, our cost-effective peptide API manufacturing ensures the best possible control of supply chain and regulatory requirements. In addition, we pioneered the production and use of pseudoproline dipeptides building blocks, which are powerful tools for bypassing challenges associated with the synthesis of difficult sequences and long peptides. CordenPharma Switzerland has additionally developed expertise in the efficient manufacture of carbohydrates (mono- and oligosaccharide building blocks and chemically-defined glycans) on a multi-kg scale. Combined with our strong expertise in fully-synthetic lipid, peptide and amino acid chemistry, CordenPharma Switzerland is uniquely positioned to manufacture glycoconjugates such as glycosyl amino-acids, glycopeptides or glycolipids. Our Swiss facility maintains an independent Quality Assurance group and Quality Control laboratories, ensuring seamless customer support in critical development areas such as analytical development & validation, cleaning method development & validation, stability studies and the filing and maintenance of documentation such as US-DMFs, EDMFs and others. Core Capabilities Synthetic Phospholipids Peptides Conjugates Carbohydrates Small Molecules Proprietary Building Blocks (small pack) - Synthetic Phospholipids - AADs - Pseudoproline Dipeptides We serve an expansive global customer base from start-up to large biotech or pharma with complex development and commercial products, R&D samples and reference standards in various stages.

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6 Technologies / Processes In addition to lipid, peptide and carbohydrate chemistry, CordenPharma Switzerland has proven scale-up experience in a broad range of chemical transformations including but not limited to: Acetylation Acylation Enantioselective synthesis Catalytic Hydrogenation (homogeneous, heterogeneous) Suzuki Coupling Sharpless Epoxidation Grignard reaction Mitsunobu reaction Organometallic reactions Phosphorylation Polymerisation Oxidation (Swern/Tempo) Wittig reaction Equipment Details Equipment for pilot batches and commercial production Kilo-lab suites for small-scale cgmp requirements Equipment capacity ranging from 20 to 160 L Reactor suites - Reactor capacity: 60 to 2500 L - Temperature range: -90 C to 160 C Drying suites - Conical dryer - Vacuum tray dryers Milling/Screening suite Large-scale chromatography CMC Development cgmp Manufacture Experienced project managers for seamless technology transfer, route scouting and process development for exclusive NCEs, excipients and high-value intermediates Manufacturing process validation studies Clinical trial and commercial material supply Analytical Support Analytical method development and validation for in-process and release testing Impurity profile characterization Reference standard production, qualification and supply to customers Cleaning method development & validation Quality & Regulatory Support Stability testing according to ICH guidelines Forced degradation studies Filing and maintenance of US-DMFs, EDMFs and others Authoring of response dossiers to authorities Specialized Purification & Isolation Equipment Preparative HPLC equipment (reversed phase; normal phase) Lyophilization Capacities Reaction vessels (multi-purpose and dedicated equipment) Pilot plant for kg-scale cgmp production in vessel volumes ranging from 20 L to 2500 L