www.cordenpharma.com

Fully Integrated Peptide

DS and DP ManufacturingCPhI Japan 2019

CordenPharma Overview

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

Your Full-Service CDMO Partner

Supply Chain Positioning

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

Raw Materials Non-GMP Intermediates

GMP Intermediates APIs DPs Pharma

Logistics

Lifecycle Positioning

CordenPharma focuses on all stages of a drug lifecycle with competitive advantages in clinical development and commercial production

Preclinical12 months

Phase I12-18 months

Phase II24 months

Registration12 month Commercial GenericPhase III

36 months

Value Chain Positioning

CordenPharma - Value Proposition Serving Global Pharma & Biotech

Customers

Organized under 5 Distinctive Technology Platforms

Broad Range of Expertise: API’s: Small Molecules, Peptides,

Lipids, Carbohydrates, Highly Potent, Cytotoxics, Conjugates

Drug Products: Oral, Liquids, Injectables, Highly Potents, Anti-infectives / Antibiotics

Global Coverage Allowing for Flexibility

Your Full-Service Provider from Clinical Development to Full-Scale Commercial Supply of APIs & Drug Products

Peptides, Lipids &Carbohydrates

Highly Potent & Oncology

Injectables

SmallMolecules

Antibiotics

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

100ml 500ml 12 L 50 L 75 L 100 L 500 L 10,000 L

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

Solid-Phase Peptide Synthesis at any Scale

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 m3 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

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

Large Scale Peptide Isolation: Precipitation vs. Lyophilization

We offer one of the largest and most competent facilities

for the fill & finish of pharmaceutical drug products worldwide.

Your Expert Partner for Clinical & Commercial Injectable Drug Product Supply

Injectables – Our Services Throughout the Development Life Cycle

Preclinical12 months

Phase I12-18 months

Phase II24 months

Registration12 month CommercialPhase III

36 months

Clinical Supply(at any Scale & Stage of Drug Product)

PharmaceuticalFormulationDevelopment

Validation & CMC Dossier Registrations Globally

Commercial Injectable Drug Product Manufacture & Supply

Secondary Packaging,Labeling, Kit Assembly & Serialization

Clinical Trial Material Management & Distribution

SmallMolecules

Peptides

Lipids & Carbohydrates

Oligonucleutides

Sterile Liquids

Sterile PowderLyophilized Vials

Pharma Packaging& Logistic

Injectables – Our Capabilities

Sterile Drug Products (Aseptic or Terminally Sterilized)

Sterile Emulsion Technology

Small & Large Molecules, incl. Peptides, Oligonucleotides & Biologics

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 PowderLyophilized (Solution)

2 Independent Aseptic Production Areas #1 PFS / cartridge #2 Vials

Aseptic Manufacturing Plant –Commercial Capabilities

Aseptic Formulation – Summary Table

Plant Filling Area Type Size Material Compound Batch Size

FillingBatch Size

CompoundType

UP3 Line #1 PFS 1 to 10mL Glass or plastic

20 to 100L 10k to 100k Solution

Cartridge 3mL Glass 20 to 100L 10k to 30k «

Line #2 Vial liq 1 to 10mL Glass or plastic

20 to 100L 10k to 100k «

Vial lyo 1 to 10mL Glass 20 to 50L 10k to 20k «

UP1 Clinicalplant

PFS 1 to 10mL Glass or plastic

5 to 50L 1k to 10k «

Vial liq 1 to 20mL Glass orplastic

5 to 50L 1k to 10k «

Vial lyo 1 to 10mL Glass 5 to 20L 1k to 4k «

CordenPharma BrusselsBrussels, BE

Peptide & Injectable Facilities

Peptides (LPPS+SPPS) Spray drying expertise Dinucleotides

Leader in Solution-Phase Peptide Synthesis & Prod.

Small to Mid scale SPPS

Pharmaceutical Commercial & Clinical API Supplies

Worldwide Compliance standards

Development by QbD

CordenPharma ColoradoBoulder, CO, USA

(HPAPI) Peptides SafeBridge Cat. 4 Certification Largest Peptide Production &

Purification capacity worldwide Proprietary Precipitation

Isolation Technologies

Pharmaceutical Commercial & Clinical API supplies

Worldwide Compliance standards

Development by QbD

Pharmaceutical Clinical & Commercial Drug Product supplies

Worldwide Compliance standards High-volume Sterile by Terminal

Sterilisation Aseptic-filling of Bio-organic APIs Clinical Trial Services Formulation & Packaging of

Parenteral Dosage Forms Sterile Vials Sterile Emulsion Technology Pre-filled Syringes

CordenPharma Caponago Caponago (Milan), It

ProcessDevelopment Scale-Up API

Manufacturing

FormulationDevelopment Scale-Up Drug Product

Manufacturing

Quality & Regulatory Support

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

Platform Unique Positioning

Your Benefits

www.cordenpharma.com

Experts taking care.

CPHI Japan 2019 Booth # xxx

Contact:Frieder MitzelCorden Pharma Internationalfrieder.mitzel@cordenpharma.comCell: +41 79 821 8270