Fully Integrated Peptide DS and DP Manufacturing CPhI Japan 2019 - PowerPoint PPT Presentation

Fully Integrated Peptide DS and DP Manufacturing CPhI Japan 2019 www.cordenpharma.com

CordenPharma Overview Your Full-Service CDMO Partner  Full-Service CDMO Organized under 5 Technology Platforms € 311 Million Total Sales (2018)   9 Manufacturing Facilities in Europe / US (8 GMP Plants, 1 R&D Laboratory)  1,570 Employees

Value Chain Positioning Supply Chain Positioning Non-GMP GMP Pharma Raw Materials APIs DPs Intermediates Intermediates Logistics  CordenPharma covers the full GMP supply chain of pharmaceutical custom manufacturing (raw materials and non-GMP pharmaceutical intermediates partially sourced from WeylChem)  API manufacturing accounts for c.62% of net sales and usually have a shorter ramp-up phase than respective Drug Product projects Lifecycle Positioning Phase III Preclinical Phase I Phase II Registration Commercial Generic 36 months 12 months 12-18 months 24 months 12 month  CordenPharma focuses on all stages of a drug lifecycle with competitive advantages in clinical development and commercial production

CordenPharma - Value Proposition  Serving Global Pharma & Biotech Peptides, Customers Lipids & Carbohydrates  Organized under 5 Distinctive Technology Platforms Highly Potent  Broad Range of Expertise: & Oncology  API’s: Small Molecules, Peptides, Lipids, Carbohydrates, Highly Potent, Cytotoxics, Conjugates Injectables  Drug Products: Oral, Liquids, Injectables, Highly Potents, Anti- infectives / Antibiotics Small Molecules  Global Coverage Allowing for Flexibility  Your Full-Service Provider from Clinical Development to Full-Scale Commercial Antibiotics Supply of APIs & Drug Products

Peptides / Lipids / Carbohydrates Key Technologies Solid-Phase Peptide Synthesis Solution-Phase Peptide Synthesis HPLC Purification Capabilities Conjugations Spray drying – Precipitation Vaccines

Peptides Expertise: Highlights

Peptide Expertise: Highlights  A Broad Range of Technical Capabilities from Process Design and Scale-Up to Commercial Manufacturing – g-scale to 100’s of kg production under full cGMP conditions  Complex Peptides & Peptidomimetics  Proprietary Process Technologies for cost-effective manufacturing  Peptide Conjugations (PEGs, Proteins, Lipids, Carbohydrates)  Cyclic Peptides & Peptides with multiple Disulfide Bridges  Short Peptides (up to 12 residues), often without HPLC purification  Arginine-rich Peptides  Long Sequences (>30-AA) at 100’s kg  CMC Section: Process & Analytical Services (stability, test methods, validations,etc)  Filings: DMF Filing (e.g. USA, EU, Japan), IND, NDA, ANDA, IMPD

Solid-Phase Peptide Synthesis at any Scale  Solid-Phase Synthesis:  Full range of synthesizer covering any scale at any stage of development  Batch automation  Large-volume solvent and waste-handling logistics  Precipitation / isolation of fragments and final APIs  Enfuvirtide fragment scale up to 920 kg 100ml 500ml 12 L 50 L 75 L 100 L 500 L 10,000 L

Liquid-Phase Peptide Synthesis State-of-the-art Manufacturing Infrastructure: Corrosion-resistant Vessels (Hastelloy)  2000 – 12,000 L pilot / commercial scale  Wide range of reactor sizes  20 L to 18,000 L vessels  Precipitation, Isolation & Drying  Heinkel 600 & 800 centrifuges  AP 300 & 600 BHS Autopress  20 L to 3 m 3 filter / dryers  50 L to 3000 L conical screw dryers 

Peptide Purification Capabilities Full range of HPLC, LPLC Scale  Orthogonal chromatography capability  Continuous acetonitrile recovery  Diagnosis & control of gel formation   Precipitation, Isolation & Drying AP 300 BHS Autopress  PSL filter / dryer  5-8 15 20 30 45 60 80 100

Purification 60 cm medium pressure column ion exchange

Large Scale Peptide Isolation: Precipitation vs. Lyophilization Advantages of Precipitation  Very straight-forward chemical procedure  Higher bulk density vs lyophilization  Possible better stability due to less surface area  Easier for formulators to handle  Inexpensive process

Your Expert Partner for Clinical & Commercial Injectable Drug Product Supply We offer one of the largest and most competent facilities for the fill & finish of pharmaceutical drug products worldwide.

Injectables – Our Services Throughout the Development Life Cycle Secondary Packaging,Labeling, Kit Assembly & Serialization Clinical Supply (at any Scale & Stage of Drug Product) Pharma Packaging & Logistic Pharmaceutical Formulation Sterile Sterile Powder Development Liquids Lyophilized Vials Validation & CMC Dossier Registrations Globally Lipids & Small Molecules Carbohydrates Clinical Trial Material Commercial Injectable Drug Management & Distribution Product Manufacture & Supply Peptides Oligonucleutides Phase III Preclinical Phase I Phase II Registration Commercial 36 months 12 months 12-18 months 24 months 12 month

Injectables – Our Capabilities  Sterile Drug Products  Small & Large Molecules, incl. Peptides, (Aseptic or Terminally Sterilized) Oligonucleotides & Biologics  Sterile Emulsion Technology  Clinical Trial Services  Packaging & Labeling

Injectables - Key Technologies Terminal Sterilization Ampoules Vials PFS (Syringes) Cartridges Solution    Suspension    Emulsion    Aseptic Fill & Finish Ampoules Vials PFS (Syringes) Cartridges Sterile Liquids (Solution)    Sterile Powder  Lyophilized (Solution)

Aseptic Manufacturing Plant – Commercial Capabilities 2 Independent Aseptic Production Areas  #1 PFS / cartridge  #2 Vials

Aseptic Formulation – Summary Table Plant Filling Area Type Size Material Compound Filling Compound Batch Size Batch Size Type UP3 Line #1 PFS 1 to 10mL Glass or 20 to 100L 10k to 100k Solution plastic Cartridge 3mL Glass 20 to 100L 10k to 30k « Line #2 Vial liq 1 to 10mL Glass or 20 to 100L 10k to 100k « plastic Vial lyo 1 to 10mL Glass 20 to 50L 10k to 20k « UP1 Clinical PFS 1 to 10mL Glass or 5 to 50L 1k to 10k « plant plastic Vial liq 1 to 20mL Glass or 5 to 50L 1k to 10k « plastic Vial lyo 1 to 10mL Glass 5 to 20L 1k to 4k «

Peptide & Injectable Facilities CordenPharma Colorado CordenPharma Brussels CordenPharma Caponago Boulder, CO, USA Brussels, BE Caponago (Milan), It (HPAPI) Peptides  Peptides (LPPS+SPPS)   Pharmaceutical Clinical &  SafeBridge Cat. 4 Certification  Spray drying expertise Commercial Drug Product supplies  Largest Peptide Production &  Dinucleotides  Worldwide Compliance standards Purification capacity worldwide  Leader in Solution-Phase  High-volume Sterile by Terminal  Proprietary Precipitation Peptide Synthesis & Prod. Sterilisation Isolation Technologies  Small to Mid scale SPPS  Aseptic-filling of Bio-organic APIs  Clinical Trial Services  Formulation & Packaging of  Pharmaceutical Commercial  Pharmaceutical Commercial & Parenteral Dosage Forms & Clinical API Supplies Clinical API supplies  Sterile Vials  Worldwide Compliance Worldwide Compliance   Sterile Emulsion Technology standards standards  Pre-filled Syringes  Development by QbD  Development by QbD

Platform Unique Positioning Fully Integrated Supply API and Drug Product: Short Time to Market  One Partner: Straightforward Communication and Project Management  Efficient Exchange between API and Drug Product Teams  Shorten Timelines Process API Scale-Up Development Manufacturing Formulation Drug Product Scale-Up Development Manufacturing Quality & Regulatory Support

Your Benefits

Contact: Frieder Mitzel Experts taking care. Corden Pharma International frieder.mitzel@cordenpharma.com Cell: +41 79 821 8270 CPHI Japan 2019 Booth # xxx www.cordenpharma.com