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

www.cordenpharma.com

Fully Integrated Peptide DS and DP Manufacturing

CPhI 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

Preclinical 12 months Phase I 12-18 months Phase II 24 months Registration 12 month Commercial Generic Phase 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 Small Molecules 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

Preclinical 12 months Phase I 12-18 months Phase II 24 months Registration 12 month Commercial Phase III 36 months Clinical Supply (at any Scale & Stage of Drug Product) Pharmaceutical Formulation Development Validation & CMC Dossier Registrations Globally Commercial Injectable Drug Product Manufacture & Supply Secondary Packaging,Labeling, Kit Assembly & Serialization Clinical Trial Material Management & Distribution

Small Molecules Peptides Lipids & Carbohydrates Oligonucleutides Sterile Liquids Sterile Powder Lyophilized 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 Powder Lyophilized (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 Filling Batch Size Compound Type 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 Clinical plant PFS 1 to 10mL Glass or plastic 5 to 50L 1k to 10k « Vial liq 1 to 20mL Glass or plastic 5 to 50L 1k to 10k « Vial lyo 1 to 10mL Glass 5 to 20L 1k to 4k «

CordenPharma Brussels Brussels, 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 Colorado Boulder, 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

Process Development Scale-Up API Manufacturing Formulation Development 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 Mitzel Corden Pharma International frieder.mitzel@cordenpharma.com Cell: +41 79 821 8270