cordenpharma general presentation 5.15
TRANSCRIPT
www.cordenpharma.com
Experts taking care.
Corporate
Capabilities
CordenPharma Overview
Formed in 2006 as the Pharmaceutical Brand of International
Chemical Investors Group (ICIG)
Full-Service CDMO Organized under 6 Technology Platforms
€ 330 Million Total Sales (2014)
10 Manufacturing Facilities in Europe / US (8 GMP Plants, 2
R&D Labs)
1,500 Employees
Your Full-Service CDMO Partner
International Chemical Investors Group (ICIG)
Privately-owned Industrial Group Focused on Chemicals & Pharmaceutical
Businesses
Focus on Chemical & Pharmaceutical Businesses
Long-term Holding Approach
23 Sites Worldwide
5,000 Employees
€ 1,200 Million Total Sales (~ $1,365 Million) - (2014)
€ 232 Million Consolidated Group Equity
90% of Sales in Fine Chemicals & Pharmaceuticals
Legacy of Operating Companies:
Weylchem: Akzo Nobel / Acordis, Albemarle, Cassella, Clariant, Mitsubishi,
RAG / Rütgers, Tessenderlo, Viance / Rockwood
CordenPharma: AstraZeneca, Bristol-Myers Squibb, Genzyme, Roche, Solvay
Spanning the entire pharmaceutical value chain
Full-Service Offerings
Non-GMP GMPFine
Chemicals
Advanced
Intermediates & APIs
Drug
ProductsAdvanced
Starting Materials
• CordenPharma Plankstadt (DE)
• CordenPharma Latina (IT)
• CordenPharma Caponago (IT)
• CordenPharma Chenôve (FR)
• CordenPharma Switzerland (CH)
• CordenPharma Colorado (USA)
• CordenPharma Farchemia (IT)
• CordenPharma Peptisyntha (BE)
• Allessa GmbH
• HydroChem Italia S.r.l.
• Miteni S.p.A.
• Nease Corporation
• WeylChem Griesheim GmbH
• WeylChem Frankfurt GmbH
• WeylChem Höchst GmbH
• WeylChem Lamotte S.A.S.
• WeylChem Switzerland Ltd.
• WeylChem US Inc.
• WeylChem Wiesbaden GmbH
• PPC (Potasse et Produits
Chimiques S.A.S.)
ICIG Chemicals & Pharma Businesses
12/2007
Abbott /
Solvay
5/2010
Bristol-Myers
Squibb
8/2011
Roche
1/2008
AstraZeneca
6/2009
AstraZeneca
2/2011
Genzyme
11/2013
Solvay
12/2012
Farchemia
11/2013
Ancora
1/2015
Orpegen
CordenPharma
Plankstadt
CordenPharma
Caponago
CordenPharma
Chenôve
CordenPharma
Latina
CordenPharma
Switzerland
CordenPharma
Colorado
CordenPharma
Farchemia
CordenPharma
Peptisyntha
CordenPharma
Woburn
CordenPharma
Heidelberg
ICIG Pharma Acquisitions
CordenPharma Mission
CordenPharma is a full-service partner
in the cGMP Contract Development &
Manufacturing of Active Pharmaceutical
Ingredients (APIs) and Drug Products.
We support leading pharmaceutical and
biotechnology companies to achieve
product success for their patients’
healthier lives.
CordenPharma International Organisation
President
PM
Peptides &
Injectables
Key Accounts
Asia Pacific
Marketing
Services
Finance Compliance
Key Accounts
US
Key Accounts
Europe
PM
Antibiotics &
Oncology
PM
High Potent &
Small Molecules
Operations
Antibiotics &
Oncology
Operations
High Potent &
Small Molecules
Operations
Peptides &
Injectables
Marketing &
Sales
Linking Together a Legacy of Expertise
Customised Service Packages organized under Technology Platforms
spanning the entire Pharmaceutical Manufacturing Process
Specialised Technologies for the Production of Oral, Sterile & Highly
Potent Pharmaceutical Drug Products and their APIs
More than 40 years of Experience in European and USA-based
Pharmaceutical Manufacturing
CordenPharma Facilities are Audited and Certified by all Relevant
Pharmaceutical Compliance and Approval Authorities
Commercial
Supply
Registration
Supply
Clinical
Manufacture
Process &
Analytical
Development
Process &
Analytical
Transfer
CordenPharma – Full-Service CDMO
CordenPharma - Value Proposition
Serving Global Pharma & Biotech
Customers
Organized under 6 Distinctive
Technology Platforms
Broad Range of Expertise:
API’s: Small Molecules, Peptides,
Lipids, Carbohydrates, Highly Potents,
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
Small Molecules
Antibiotics
OncologyPeptides,Lipids &Carbohydrates
Injectables
Highly Potent
1. Experienced, Global Approach
Legacy of innovator companies available for global customers
Originated from innovative pharmaceutical companies with high standards of quality
2. Global Supply Chain for Selected Platforms
CordenPharma covers the whole value chain – from Intermediates to full cGMP Commercial
Scale supply of APIs, Finished Dosage Forms and Logistics
3. Reliable Primary & Secondary Source
Customised service packages in our Technology Platforms spanning the entire process of
pharmaceutical manufacturing with a strong track record
4. Focused Service Provider with Specialised Technologies
Development of APIs, Formulation, Clinical, & Commercial supplies including Pharma-Logistics
Sophisticated Technology Platforms (e.g. Peptides, Steriles, Oncology, Highly Potent)
5. Global Markets & Compliance
All plants audited by all relevant pharmaceutical compliance and approval authorities
We supply worldwide, for both nationally and internationally oriented pharmaceutical customers
CordenPharma Solutions
Caponago
Chenôve
Brussels
Latina
Plankstadt
Liestal
Boulder
Bergamo
Full-Service CDMO for a Global Market
API Drug Product
API
Dev.
Custom
Manuf.Generic
Manuf.Form.
Dev.
Form.
Manuf.
Clinical
Supply
Services
Packaging
Dev.
Packaging
Manuf.
Pharma
Log.
Validation & Regulatory Services
Compliance
Market Agency Boulder Caponago Chenôve Latina Liestal Plankstadt Bergamo Brussels
EMEA, EU local
FDA
PMDA
TGA
Health Canada
ANVISA
Project Management Lifecycle
Team Definition
- Project Kick off
Development & Readiness Activities
- Dev. / Transfer
- Regulatory
- Supply
- EHS
- Plant
Documented Batches
- Documentation
- Batch Execution
- Reporting & CMC
Submission & Approval
- Submission
- Approval
Lifecycle Commercial
- Launch & Commercial Supply
CordenPharma - NPI Execution Process
Quality by Design (QbD)
QbD Driven Development provides robust
manufacturing, science-based process
limits and assurance of Quality Attributes
within the control space (design space)
Construct Quality Target Profile (QTPP)
and identify and confirm the Critical
Quality Attributes (CQAs)
Deliver Process Knowledge at multiple
levels to achieve Product Quality and
Characteristics Definition and Process
Parameters Identification
Continuous Process Monitoring and
Process Verification during routine
manufacturing ensures a reliable supply
chain for our customers
Quality by Design
Continuous Improvement
Life Cycle Management
Liestal
Boulder
OEB 1 OEB 2 OEB 3 OEB 4 OEB 5
Occupational Exposure Bands
100 – 1.000
µg/m3
10 - 100
µg/m3
1 - 10
µg/m3
≤ 1
µg/m3
> 1.000
µg/m3
airlock access, directional
air-flow and process
containment-gowning
local exhaust ventilation,
single pass air
Plankstadt
Boulder
Latina Onco
Plankstadt
Boulder
Occupational
Exposure Limit
Containment
Equipment
CordenPharma
Operations
CordenPharma Exposure Bands
Caponago, Italy,
Formulation
Latina, Italy,
API & Formulation
Plankstadt, Germany,
Formulation
Liestal, Switzerland,
API
Chenôve, France,
API
Heidelberg, Germany,
R&D
Bergamo, Italy,
API
Brussels, Belgium,
API
Boulder, CO, USA,
API
Woburn, MA, USA,
Carbohydrate Synthesis
United States
Europe
CordenPharma Manufacturing Facilities
CordenPharma Advantages
FLEXIBILITY
CordenPharma is a highly
flexible, cost-effective
provider in the development
and custom manufacturing
of pharmaceutical products
for global markets.
QUALITY
Highest level of quality,
SHE and compliance
standards in state-of-art
facilities, originating from
innovative pharmaceutical
companies.
EXPERTISE
CordenPharma has an
unsurpassable expertise in
APIs, liquid and solid
dosage form development,
manufacture and handling.
Flexibility Expertise Quality
CordenPharma Latina
Development & Manufacturing of Oral &Sterile
Liquid and Lyo Dosage Forms for
Oncology & Cytotoxics
Development & Manufacturing of Oral & Sterile
Powder Dosage Forms for Cephalosporins &
Penicillins in Dedicated Facilities
Development & Manufacturing of Sterile APIs
for Cephalosporins, Penicillins &
Monobactams in Dedicated Facilities
Full Range of Services from Development to
Serialised Packaging
Global Compliance (e.g. FDA, EMA, PMDA,
ANVISA) and ISO14001 & OHSAS 18001
Excellent Track Record in Customer Service
Location: Sermoneta, Rome Italy
Acquisition: June 2010
Employees: 520
Core Competencies
• API & DP Sterile Manufacturing
• Supply to Japan, US & EU
• Oncology Formulation
• Segregated Betalactams Handling
• Sterile Liquids-Lyo-Powders
• Tablet-Capsule-Oral Suspensions
CordenPharma Caponago
Formulation & Packaging of Parenteral
Dosage Forms
Sterile Emulsion Technology
Pre-filled Syringes
Clinical Trial Drug Kits Distribution
& Logistics
Formulation & Analytical Development
Approved by FDA, Anvisa, TGA &
local authorities
Location: Caponago, Milan, Italy
Acquisition: June 2009
Employees: 300
Core Competencies
• Formulation, Terminal Sterilization,
Aseptic Fill & Finish, Inspection &
Packing of Parenterals
• Filling of Ampoules, Vials,
Lyophilised Vials & Syringes in
1 – 200ml range
• Extended Analytical & Micro-
biological Tests, Stability Studies
CordenPharma Farchemia
Manufacturer of Small Molecule Active
Pharmaceutical Ingredients (APIs) &
Advanced Intermediates for the
Pharmaceutical and Veterinary Industries
Broad Range of Chemistry Capabilities
Site Regularly Inspected by more than 200
Customers, including all of the Top 10
Pharma Companies – Track Record with the
FDA since 1979
Excellence in Customer Service
Location: Bergamo. Italy
Acquisition: December 2012
Employees: 150
Core Competencies
• cGMP Custom Synthesis from Lab
to Multi-ton Scale – 600 m3 Capacity
• Multi-steps API Process
Development, Manufacturing &
Analytical Development
• Industrialization from Feasibility to
Commercial-scale
CordenPharma Chenôve
Manufacturer of Small Molecule Active
Pharmaceutical Ingredients (APIs) &
Advanced Intermediates for the
Pharmaceutical and Veterinary Industries
Site Regularly Inspected by more than 100
Customers, including the Top 10 Pharma
Companies – Track record with the FDA
since 1995
Specific Expertise in Several Cutting Edge
New Chemical Technologies
Location: Chenôve, France
Acquisition: December 2007
Employees: 110
Core Competencies
• Reliable Commercial Supply of High
Quality APIs & Intermediates
• Rapid Process Research & Scale-up
for all-sized Pharma APIs or
Advanced Intermediates
• Comprehensive Service from
Process Research to DMF Writing
and Filing
CordenPharma Colorado
Integrated Resource for the Development &
Manufacture of Advanced Intermediates
and APIs for Global Pharmaceutical and
Biotechnology Industries
Development & Manufacture of Complex
Synthetic Peptides and Conjugates
Development & Manufacturing of Highly
Potent, Cytotoxic & Non-Cytotoxic APIs
Excellent Track Record in Development from
Early Stage to Launch
SafeBridge® IV Certified
Location: Boulder, Colorado USA
Acquisition: September 2011
Employees: 205
Core Competencies
• Leader in Development &
Manufacture of Synthetic Peptides
• Process Analytical Technology &
Track Record in Regulatory Filing
• Development & Scale-up of Highly
Potent & Oncology APIs
CordenPharma Switzerland
Recognized Expertise in Peptides, Lipids &
Carbohydrate APIs
Conjugation Expertise for Receptor
Targeting & Drug Delivery
Full Range of Equipment supporting a wide
range of Services from Advanced Key
Intermediates to Final APIs for Clinical &
Commercial Use
Track Records in Successful Regulatory
Inspections by Global Agencies
Location: Liestal, Switzerland
Acquisition: March 2011
Employees: 100
Core Competencies
• N°1 in Fully Synthetic Lipid
• Solid & Solution-Phase Peptide
Synthesis
• GMP Carbohydrate Expertise
• Readily Available Lipids & Peptide
Building Blocks (Pseudoprolines,
Non-Natural Amino Acids)
CordenPharma Plankstadt
Development & Manufacturing of Solid
Dosage Forms for the Global Market
Special Expertise & Capabilities in the
Formulation of Highly Potent & Oncology
Products
Full Range of Services including Formulation
& Analytical Development, Clinical Supplies
Global Compliance (e.g. FDA, EMA, PMDA,
ANVISA)
Excellent Track Record in Customer Service
Location: Plankstadt, Germany
Acquisition: Feb 2008
Employees: 200
Core Competencies
• Development, Clinical &
Commercial Supplies of Highly
Potent & Oncological Products
• Primary & Secondary Packaging
including Handling of all types of
Foil & Bottles
• Quality by Design, PAT &
Containment
CordenPharma Peptisyntha
Dedicated to Peptide Development, Clinical &
Commercial Supply up to 100s of kg
Complex Peptides & Peptidomimetics
Peptide-Conjugations & Cyclic Peptides
Proprietary Technologies
Short Peptides, often without HPLC Purification
Track Records in Successful FDA & EMA
Inspections
Quality & Regulatory Services: CMC, DMF for
IND, NDA, ANDA & IMPD Filings
Location: Brussels, Belgium
Acquisition: November 2013
Employees: 65
Core Competencies
• Proprietary Technologies
• Constrained Peptides
• Solution-Phase Peptide Synthesis
• Arginin-rich Peptides
• Short Peptides with no HPLC
www.cordenpharma.com
Experts taking care.Peptides / Lipids /
Carbohydrates Platform
Peptides / Lipids / Carbohydrates Platform
Your Expert Partner for Bio-Organic APIs
Proven track record delivering world class manufacturing services from early stage to commercial supply, including the most complex peptides.
Proprietary process technologies for cost-effective manufacturing and a robust CMC dossier by reducing the number of chemical steps, increasing purity and decreasing raw material costs.
A unique combined expertise in peptides, carbohydrates and synthetic lipids offering access to a wide range of products to suit customer needs, including conjugates.
Multiple cGMP manufacturing locations across Europe and USA offering flexibility of supply.
Peptides / Lipids / Carbohydrates Platform
Peptides
Carbo-hydrates
Lipids
Your Expert Partner for Bio-Organic APIs
Areas of Indication APIs covering a wide range of
therapeutic indications
Vaccines
Adjuvants
Drug Delivery Systems
Drug Targeting: Conjugations
Peptides / Lipids / Carbohydrates
Key Technologies
Solid-Phase Peptide Synthesis
Solution-Phase Peptide Synthesis
HPLC Purification Capabilities
Lipids Technology
Carbohydrates Technology
Conjugations
Peptide / Lipids / Injectables Overview
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
Solution-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 cm 8 cm 15 cm 30 cm 45 cm 80 cm 100 cm
Peptide / Lipids / Carbohydrates Platform -
Track Record from Early Stage to Launch
• Antiviral API (HIV) requiring 106 synthetic steps and 36 amino acid peptide. Multi-100’s kg p.a.
Fuzeon / Enfuvirtide
• Diabetes II API requiring 68 synthetic steps and 33 amino acid peptide
Taspoglutide
• Cyclic peptidomimetic for cardiovascular (platellet-aggregation)
Eptifibatide
• Six Cysteine amino acids; 3 disulfide bridges
Linaclotide
• Gonadotropin-hormone releasing agonist – highly potent API, exposure level 1ng/m3
Nafarelin
• Anti-ulcer compound (Prostaglandin) 28 steps
Enprostil:
• Osteosarmcoma therapy, conjugate of lipid-carbohydrate-peptide
Mifamurtide
Peptisyntha
Bussels, BE
CordenPharma Switzerland
Liestal, CH
Peptide / Lipids / Carbohydrates Facility Overview
Pharmaceutical Commercial &
Clinical API Supplies
Worldwide Compliance standards
Development by QbD
Leader in Solution-Phase Peptide
Synthesis & Production
Peptidometics, Constrained
Peptides & Cyclic Peptides
Proprietary Process Technologies
LPPS & SPPS capabilities
Argo-containing Peptides
Short Peptides, often with no
HPLC purification
CordenPharma Colorado
Boulder, CO, USA
Pharmaceutical Commercial &
Clinical API supplies
Worldwide Compliance standards
Development by QbD
Catalytic Asymmetric
Hydrogenation, access to unusual
Amino Acids
#1 in Pseudoproline Dipeptides
Peptide Synthesis SPPS / LPPS,
Conjugation, Lyophilization
#1 in fully Synthetic Lipid
Chemistry
Substantial Carbohydrate
expertise – small to large-scale
production
Pharmaceutical Commercial &
Clinical API supplies
Worldwide Compliance standards
Development by QbD
Synthetic Peptides
Highly Potent & Oncology APIs
Manufacturing of Highly Potent
Peptides – SafeBridge Category 4
Certification
Largest Peptide Production &
Purification capacity worldwide
Complex Peptide manufacturing
using SPPS & proprietary
Precipitation Isolation Technologies
Injectables Platform
www.cordenpharma.com
Experts taking care.
Injectables Platform
Your Expert Partner for Clinical & Commercial Injectable Drug Product Supply
Long outstanding experience supplying high quality Drug Product manufacturing services from early stage drug development to global commercial supply.
Substantial Drug Product filing experience globally (EU, USA, Japan, Canada, Australia).
Full-service offering and project management from APIs to final Drug Products including packaging / labeling and clinical trial drug kits management (logistics, track-trace and documentation).
Injectables Platform
• Full Development capabilities for Small Molecules & Biorganic APIs (Peptides, Lipids & Carbohydrates)
• Integrated Development & Supply
Pharmaceutical Development
• Clinical Supply at any scale and stage of development
• Preclinical toPhase III
Clinical Supply• Full Logistic Services with Track and Trace of the Drug at multiple Clinical Trial Sites
Clinical Trial Material
Management
• Ampoules, Vials, PFS
• Automatic and Semi-Automatic Inspection lines
SecondaryPackaging &
Labeling
• Validation & Dossier Registration globally
• Supply to all major markets
Commercial
Supply
Your Expert Partner for Clinical & Commercial
Injectable Drug Product Supply
Injectables Platform Key Technologies
Emulsion Filling: Low Soluble Drugs
Terminal Sterilisation: Heat & Steam Rotating Autoclaves
Aseptic Filling & Testing of Peptide, Lipids & Carbohydrate-based Drugs
Large Pre-filled Syringes (Barrel)
Clinical Trial Supply Management: Placebo & Comparators, Labeling, Randomisation & Secondary Packaging, Logistics
Injectables Platform - Track Record
• Large Capacity: Manufacturing & Packaging of >50 million units per year: PFS, Vials
• Multiple Formulations and Dossiers successfully filed
Propofol: Innovator AstraZeneca (Diprivan)
• 150 SKUs and supplying >108 markets
• >15 Leading Generic Companies
Propofol
• Multiple Custom Development and Dossier preparation for Global Generic Companies
• Formulation & Analytical Development, Validations and CMC packages for ANDA filing
Generic Products
• Formulation Development, non-GMP & GMP Vial production, PFS & Lyophilized Drug Products
• Quality & Regulatory Support throughout the clinical development
• Clinical Trial Supply Services: Kits Management & Supply to Clinical Trial Sites
Customer Development Products
Track Records in Successful Inspection by all Major Regulatory Authorities: FDA, EMA, ANVISA, TGA
CordenPharma Caponago
Caponago, IT
Injectables Facility Overview
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
Highly Potent &
Oncology Platforms
www.cordenpharma.com
Experts taking care.
Highly Potent & Oncology Platforms
The Expert Source for Highly Potent & Oncological Products
Multiple manufacturing locations across Europe and the US offering flexibility of supply & project management from APIs to final Drug Products, including packaging / labeling in globally approved facilities.
Multi-purpose facilities specifically designed to safely handle Highly Potent Substances with containment solutions up to OEB 5 . Our containment culture guarantees protection of operators and the environment.
Leading service provider in the synthesis, development, formulation and packaging of Highly Potent APIs and Drug Products for customers worldwide.
Leading service provided in the production of Oncological Oral-grade APIs and Oral / Sterile Drug Products for customers worldwide.
Highly Potent & Oncology PlatformsThe Expert Source for Highly Potent
& Oncological Products
Highly Potent API Development & Commercial Manufacturing –
SafeBridge Category 4, OEB 5 ≤1 ng/m3
Oncological Oral APIs
Highly Potent Drug Products (Tablets & Capsules), including
Primary & Secondary Packaging (Blister, Bottle, Serialisation, 2D
Matrix Coding)
Oncological Oral Dosage Products (Tablets & Capsules)
and Sterile Liquid & Lyofilisation(Vials & Ampules);
Development by QbD
Highly Potent & Oncology Platforms
APIs
Drug
Products
Highly Potent Oncology
Highly Potent & Oncology Platforms
Key Technologies
SafeBridge Certified APIs
OEB 4 & 5 Manufacturing
Tablets & Capsules
Sterile Liquid & Lyophilised
Development QbD
Highly Potent & Oncology Track Record
• Oncology Sterile Liquid
Taxol
• Oncology Sterile Liquid
Paraplatin
• Oncology Oral
Hydrea
• HPAPI
Valgan
• Oncology Sterile Liquid & Lyophilisation
Platinol
• Oncology Oral & Sterile
Vepesid:
• Oncology Sterile
Ixempra
CordenPharma Latina
Latina, IT
CordenPharma Plankstadt
Plankstadt, DE
Pharmaceutical Clinical &
Commercial Drug Product supplies
Worldwide Compliance Standards
Development by QbD
HPAPIs & Oncology Formulation
with clearly defined no effect
threshold (PDE)
Containment validated down to
1 µg (lower OEL possible)
HSG, FBG, DC & Film Coating
Processes for 100 – 200 kg
Capacity of 2-3 billion Tablets /
year
Highly Potent & Oncology Facilities Overview
Pharmaceutical Commercial &
Clinical API supplies
Worldwide Compliance Standards
Development by QbD
Synthetic Peptides
Highly Potent & Oncology APIs
Manufacturing of Highly Potent
Peptides – SafeBridge Category 4
Certification
Largest Peptide Production &
Purification capacity worldwide
Complex Peptide manufacturing
using SPPS & proprietary
Precipitation Isolation Technologies
CordenPharma Colorado
Boulder, CO, USA
Pharmaceutical Commercial &
Clinical API & Drug Product
supplies
Worldwide Compliance Standards
Dedicated manufacturing lines &
development by QbD
Oral & Sterile Formulation of
Oncology OEB 4/5 Cytotoxic
substances (Ames Positive)
Sterile & Oral Cephalosporin APIs
& Drug Products
Sterile & Oral Penicillin APIs &
Drug Products
Sterile & Oral Monobactam APIs
& space for Drug Products
Antibiotics Platform
www.cordenpharma.com
Experts taking care.
Antibiotics Platform
Supply Solutions for Segregated Antibiotics & More
Dedicated API and Drug Product facilities for Segregated & Non-Segregated Antibiotics.
Multiple manufacturing locations across Europe and USA offering flexible supply solutions for the different stages of the value chain both for APIs and Drug Products.
Full-service offering and project management from API to final Drug Product, including packaging and labeling in globally approved facilities.
Oral & Sterile APIs & Drug Product solutions.
Antibiotics Platform
Supply Solutions for Segregated
Antibiotics & More
Cepha-losporins
Non-Segre-gated
Mono-bactams
Penicillins
Supply Solutions for
Segregated Antibiotics & More
Antibiotics Platform Key Technologies
Segregated Facilities
Development & Manufacturing
API Sterile Crystallisation
Drug Product Sterile Powder Filling
Capsules, Tablets, POS
Antibiotics Platform Overview
Monobactams
API CDMO
- Development by QbD
- Oral API
- Sterile APIs (Crystallisation)
- From lab to pilot plant to full commercial scale manufacturing
DP CDMO
- Development by QbD
- Space available for formulation expansion
Penicillins
API CDMO
- Oral APIs
- Sterile APIs (Crystallisation)
- Sterile Blending
DP CDMO
- Development by QbD
- Sterile Powder Filling
- Filling of Powder Oral Suspensions
- Capsules Filling
- Packaging
Cephalosporins
API CDMO
- Development by QbD
- Oral APIs
- Sterile API (Crystallisation)
- Sterile Blending
DP CDMO
- Development by QbD
- Sterile Powder Filling
- Filling of Powder Oral Suspensions
- Capsules Filling
- Coated Tableting
- Packaging
Non-Segregated AB
API CDMO
- Development by QbD
- Clinical supply
- Commercial Supply
DP CDMO
- Development by QbD
- Clinical Supply
- Capsules Filling
- Coated Tableting
- Sterile Liquid & Lyo Vials
- Sterile Liquid Syringes
- Packaging
Antibiotics Platform Track Record
• Sterile Cephalosporin Antibiotics
Maxipime
• Oral Cephalosporin Antibiotics
Cefzil
• Oral Cephalosporin Antibiotics
Duracef
• Oral & Sterile Penicillin Antibiotics
Pentrexyl
• Oral & Sterile Penicillin Antibiotics
Bristopen
• Sterile Monobactam
Azactam
• Non-Segregated Antibiotic part of WHO’s List of Essential Medicines
Metronidazole
Antibiotics Facility OverviewCordenPharma Caponago
Caponago, IT
CordenPharma Latina
Latina, IT
Pharmaceutical Commercial &
Clinical API & Drug Product
supplies
Worldwide Compliance Standards
Dedicated manufacturing lines &
development by QbD
Oral & Sterile Formulation of
Oncology OEB 4/5 Cytotoxic
substances (Ames Positive)
Sterile & Oral Cephalosporin APIs
& Drug Products
Sterile & Oral Penicillin APIs &
Drug Products
Sterile & Oral Monobactam APIs
& space for Drug Products
CordenPharma Plankstadt
Plankstadt, DE
Pharmaceutical Clinical &
Commercial Drug Product supplies
Worldwide Compliance Standards
Development by QbD
HPAPIs & Oncology Formulation
with clearly defined no effect
threshold (PDE)
Containment validated down to
1 µg (lower OEL possible)
HSG, FBG, DC & Film Coating
processes for 100-200 kg
Capacity of 2-3 billion Tablets /
year
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 Switzerland
Liestal, CH
Antibiotics Facility OverviewCordenPharma Colorado
Boulder, CO, USA
Pharmaceutical Commercial &
Clinical API supplies
Worldwide Compliance Standards
Development by QbD
Synthetic Peptides
Highly Potent & Oncology APIs
Manufacturing of Highly Potent
Peptides – SafeBridge Category 4
Certification
Largest Peptide Production &
Purification capacity worldwide
Complex Peptide Manufacturing
using SPPS & proprietary
Precipitation Isolation Technologies
Pharmaceutical Commercial &
Clinical API supplies
Worldwide Compliance Standards
Development by QbD
Catalytic Asymmetric
Hydrogenation, access to unusual
Amino Acids
#1 in Pseudoproline Dipeptides
Peptide Synthesis SPPS / LPPS,
Conjugation, Lyophilization
#1 in fully Synthetic Lipid
Chemistry
Substantial Carbohydrate
expertise – small to large-scale
production
Farchemia
Bergamo, IT
Antibiotics Facility OverviewCordenPharma Chenove
Chenove, FR
Commercial & Clinical API supplies
Worldwide compliance Standards
Multi-step process development,
manufacturing & analytical
development
Development by QbD
Development & scale-up of Small
Molecule APIs (kilo-lab & full scale)
Enzymatic Synthesis
Pharmaceutical establishment for
Bulk Pre-mixed Drug Products
Commercial & Clinical API and
Advanced Intermediate supplies
Process research & development
of Advanced Intermediates & APIs
Multiple Isolation Trains
Core competencies
cGMP custom synthesis from
gram-scale to multi-ton scale
Around 600 m3 capacity in an
advanced multi-purpose facility
Small Molecules Platform
www.cordenpharma.com
Experts taking care.
Small Molecules Platform
Full-service Partner of Choice for Advanced Intermediates to Drug Products
Diversified and multi-purpose services with extensive capabilities from small scale to large scale, spanning development to commercial manufacturing.
Multiple manufacturing locations across Europe and USA offering flexibility of supply.
Full-service offering and project management from Advanced Intermediates and APIs to final Drug Products, including packaging / labeling and clinical trial drug kits management (logistics, track-trace & documentation).
Small Molecules Platform
Full-service Partner of Choice for Advanced
Intermediates to Drug Products
Proprietary Advanced Intermediates & APIs
Generic Advanced Intermediates & APIs
APIs & Excipients
Solid Oral
Clinical Trial Services
Sterile Emulsion Technology
Packaging & Labeling
Aseptic Filled Injectable Drug Products
Terminally Sterilized Injectable Drug Products
Drug Products
Small Molecules Key Technologies
Development & Manufacturing
Gram to Multi-ton Scale
R&D and Analytical Development
Enzymatic Processes
Natural Extract Products
Small Molecules Track Record
• Anti-Hypertensive API (HIV) requiring multiple chemical and enzymatic steps
Nebivolol
• Vasoprotector API
Tribenoside
• Natural extract product, pre-mixed bulk drug product in multi-ton scale
Pygeum
• API used in hypercholesterolemia: worldwide market producer
Fenofibrate
• Antihistaminic API: worldwide market producer
Doxylamine
• Serving all of the top 10 Pharma Companies
Custom Synthesis products
Small Molecules Facility Overview
CordenPharma Plankstadt
Plankstadt, DE
CordenPharma Colorado
Boulder, CO, USA
CordenPharma Chenove
Chenove, FR
Pharmaceutical Clinical &
Commercial Drug Product supplies
Worldwide Compliance Standards
Development by QbD
HPAPIs & Oncology Formulation
with clearly defined no effect
threshold (PDE)
Containment validated down to
1 µg (lower OEL possible)
HSG, FBG, DC & Film Coating
processes for 100-200 kg
Capacity of 2-3 billion Tablets /
year
Commercial & Clinical API supplies
Worldwide compliance Standards
Multi-step process development,
manufacturing & analytical
development
Development by QbD
Development & scale-up of small
molecule APIs (kilo-lab & full scale)
Enzymatic Synthesis
Pharmaceutical establishment for
Bulk Pre-mixed Drug Products
Pharmaceutical Commercial &
Clinical API supplies
Worldwide Compliance Standards
Development by QbD
Synthetic Peptides
Highly Potent & Oncology APIs
Manufacturing of Highly Potent
Peptides – SafeBridge Category 4
Certification
Largest Peptide Production &
Purification capacity worldwide
Complex Peptide Manufacturing
using SPPS & proprietary
Precipitation Isolation Technologies
Small Molecules Facility OverviewCordenPharma Caponago
Caponago, IT
Farchemia
Bergamo, IT
CordenPharma Switzerland
Liestal, CH
Commercial & Clinical API &
Advanced Intermediate supplies
Process research & development
of Advanced Intermediates & APIs
Multiple Isolation Trains
Core competencies
cGMP custom synthesis from
gram-scale to multi-ton scale
Around 600 m3 capacity in an
advanced multi-purpose facility
Pharmaceutical Commercial &
Clinical API supplies
Worldwide Compliance Standards
Development by QbD
Catalytic Asymmetric
Hydrogenation, access to unusual
Amino Acids
#1 in Pseudoproline Dipeptides
Peptide Synthesis SPPS / LPPS,
Conjugation, Lyophilization
#1 in fully Synthetic Lipid
Chemistry
Substantial Carbohydrate
expertise – small to large-scale
production
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
Full-Service CDMO for a Global Market
Organized under 6 Technology Platforms
Global Compliance & Reliable Supply Chain
Surpassing Standards for Pharmaceutical Manufacturing
Inspired Global Service & Flexible Solutions
Your Full-Service CDMO Partner
www.cordenpharma.com
Experts taking care.
Contact
Christian Ahlmark
Associate Director
Sales & Key Account Management
CordenPharma International
Tel: +1 919 824 0317