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www.cordenpharma.com
Experts taking care.
Continuous Manufacturing
CordenPharma
CordenPharma Overview
Full-Service CDMO Organized under 5 Technology Platforms
€ 365 Million Total Sales (2016)
11 Manufacturing Facilities in Europe / US (9 GMP Plants,
2 R&D Labs)
1,670 Employees
Your Full-Service CDMO Partner
International Chemical Investors Group (ICIG)
Market Oriented Platforms
Corporate headquarters in Luxembourg and Frankfurt
Back-office, ICIG Business Services, located in Wuppertal, 65 employees
Sales: € 360 million
Employees: ~ 1,700
Sales: € 140 million
Employees: ~ 1,090
ENKA Group
CarboTech AC
Rütgers Organics
Sales: € 620 million
Employees: ~ 1,950
Sales: € 800 million
Employees: ~ 1,100
CordenPharma
Group
WeylChem
Group
VYNOVA
Group
IT, Accounting, Finance, Human Resources, Legal
Fine Chemicals Pharma Enterprises Chlorovinyls(1)
ICIG Business Services
CordenBioChem
Highlights
Privately owned industrial holding, focused on mid-
sized chemicals & pharmaceutical businesses
Opportunities of consolidation and outsourcing in
chemicals and pharmaceuticals
Inception in 2005
29 manufacturing facilities with approximately
6,000 employees in Europe and the United States
Total sales of approx. € 2 billion
Heritage of operating companies:
Chemicals: Akzo Nobel / Acordis, Albemarle,
Clariant, INEOS / INOVYN, Mitsubishi, RAG /
Rütgers, Rockwood / Viance, Tessenderlo
Chemie
Pharma: Solvay, AstraZeneca, Bristol-Myers
Squibb, Harris & Harris, Novartis / Sandoz,
Roche, Sanofi / Genzyme
Sales Breakdown by Platform (2016)
ICIG Overview
Sales Development in €m
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 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.
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 5 Distinctive Technology
Platforms
Broad Range of Expertise:
• API’s: Small Molecules, Peptides,
Oligonucleotides, 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,
Oligonucleotides,
Lipids &
Carbohydrates
Highly Potent
& Oncology
Injectables
Small
Molecules
Antibiotics
Liestal
Boulder
OEB 1 OEB 2 OEB 3A OEB 3B OEB 4
Occupational Exposure Bands
100 – 10
µg/m3
10 - 1
µg/m3
1 - 50
ng/m3
˂ 50
ng/m3
≥ 100
µg/m3
Latina
Plankstadt
Boulder
Occupational
Exposure Limit
CordenPharma
Operations
CordenPharma Exposure Bands
Latina
Plankstadt
Boulder
High Potency
Highlights
Marketing & Sales are centralized within the
service entity CordenPharma International
Regional organizational set-up with focus on key
accounts and platform marketing strategy, partially
supported by onsite personnel
Responsibilities:
Customer relationship management and
responsibility for group sales plan
Geared towards the five platforms and
allocation of projects to sites (centralized
electronic project database)
Protection of brand and business (increase
“CordenPharma” brand recognition)
Clear processes, accountabilities and aligned
incentive schemes
Agency agreements for Japan and India
Additional expansion in Brazil planned
PM Small Molecules
& Antibiotics (1)
PM Highly Potent
& Oncology (1)
Key Accounts
United States (6)
Key Accounts
Europe (3)
Key Accounts
Asia Pacific (1)
Marketing & Sales
CordenPharma International
15 Life Science Leader CMO
Leadership Awards in 2017
More than 80 CMOs
assessed by 26
performance metrics in
ISR’s annual Contract
Manufacturing Quality
Benchmarking survey.
CordenPharma Marketing & Sales
Industry Recognition
PM Pep, Oligo,
Lip, Carb &
Injectables (2)
Marketing
Services (2)
CordenPharma International Organisation
President
Platform Dir. Peptides, Oligos,
Lipids & Carbs
Key Accounts
Asia Pacific
Marketing
Services
Finance Compliance
Key Accounts
North
America
Platform Dir. Small Molecules
& Antibiotics
Platform Dir. Highly Potent
& Oncology
Marketing &
Sales Operations
Key Accounts
Europe
Platform Dir. Injectables
Caponago, Italy,
Formulation
Latina, Italy,
API & Formulation
Plankstadt, Germany,
Formulation
Liestal, Switzerland,
API
Chenôve, France,
API
Frankfurt, 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 Group has its own senior management responsible for group operations, financials and strategy
Senior management is supported by platform directors and site managing directors
Interfaces with ICIG / ICIG Business Services
Monitoring and support of local management in the areas of strategy, finance & accounting, HR, compliance
Regular financial and operational reporting and 3 year forecast with three revisions p.a.
Aligned targets and incentive schemes set by ICIG
CordenPharma Platform & Site Management
Executive Leadership Platform Directors Site Managing Directors
Dr. Riku Rautsola
CEO & President
Dr. Walter Kittl
Chief Operating Officer
Dr. Michael Quirmbach
Chief Business Officer
Dr. Frank Haehner
Managing Director,
Plankstadt (DE)
Yves Michon
Managing Director,
Chenôve (FR)
Brian McCudden
Managing Director, *
Boulder & Colorado (US)
* Brian McCudden also serves as
President & CEO
Laura Coppi
Managing Director,
Bergamo & Latina (IT)
Dr. Jürg Burger
Managing Director,
Liestal (CH)
Patrice Locht
Managing Director,
Brussels (BE)
Dr. Macniell Esua
Chief Compliance
Officer
Jason Bertola
Director, Highly Potent
& Oncology Platform
Dr. Stephen Houldsworth
Director, Small Molecules
& Antibiotics Platform
Dr. Matthieu Giraud
Director, Peptides, Oligos,
Lipids & Carbs Platform
Fabio Stevanon
Director, Global
Injectables Platform
Fabrizio Fiordigiglio
Managing Director,
Caponago (FR)
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
CordenPharma Solutions
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
Full-Service CDMO for a Global Market
Bergamo
Boulder
Brussels
Caponago
Chenôve
Latina
Liestal
Plankstadt
API Drug Product
API
Dev.
Custom
Manuf. Generic
Manuf. Form.
Dev.
Form.
Manuf.
Clinical
Supply
Services
Packagin
g Dev.
Packagin
g Manuf.
Pharma
Log.
Validation & Regulatory Services
Colorado
These standards are binding for each CordenPharma facility &
conceived to harmonize quality & compliance practices within
CordenPharma.
Each CordenPharma site shall timely implement and comply with the
Corporate Standards.
Internal audits are performed by the Corporate Compliance team for
ensure proper implementation and alignment.
Compliance Corporate Standards
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
Slide 19
CordenPharma Interest for
Continuous Process
As a CDMO, we believe that improvement through process
technologies and first class services is essential for success
We consider that the alliance of chemical and process
engineering is essential to achieve the best overall performance.
Continuous process has been selected as a technology able to
deliver on purpose significant advantages in Process
Robustness, Selectivity, Quality, Cost and Safety. For high
value components, it also minimize the financial risk thanks to the
reduced amount of in process material.
CordenPharma Interest for Continuous Process
Slide 20
Slide 21
CordenPharma Continuous Process: Case Study
CordenPharma has been questioned by a Pharma company for the
service of producing an API with a batch process.
After analysis of the process, according to the nature of the
products and the expected quantities, CordenPharma went to the
conclusions that:
A dedicated production line was highly preferable for quality reasons
The multi-steps batch process would lead to excessive non productive
handling and transfers of Intermediates and Finished Product
Slide 22
CordenPharma Continuous Process: Case Study
Due to its expertise in continuous process, CordenPharma had the
idea to design a dedicated Continuous Process to best comply
with quality & quantities and reach the targeted price.
A preliminary Continuous Process flow diagram has been
designed by CordenPharma based on the data from the batch
process.
A list of equipment has then been issued with their related
specifications along with a preliminary mass balance.
Slide 23
CordenPharma Continuous Process: Case Study
Capex and Opex for this continuous production line have then been
evaluated according to the process diagram and CordenPharma’s
operating assumptions.
CordenPharma then sent its offer with the figures related to this
continuous process data and considerations.
The flow diagram and the list of equipment were part of the offer, as
well as the various options related to process efficiency.
Slide 24
CordenPharma Continuous Process: Case Study
After an initial sign of interest from the pharma
company, CordenPharma and the company
engaged discussions on how to establish evidences
on this Continuous Process feasibility and
advantages.
At this point , CordenPharma offered a Proof of
Concept milestone based on a Laboratory small
scale Continuous Process demonstration.
Deliverables were a report comprising a mass and
thermal balance, yields calculation and purity
analysis on samples.
Slide 25
CordenPharma Continuous Process: Case Study
CordenPharma proposed the payment of the Proof of Concept
including a part as Success fees, at the sole discretion of the
Pharma Company, based on the report’s content and visit at
CordenPharma’s Process Development laboratory.
Mutual agreement has been reached on this approach.
According to this, CordenPharma built and operated in a timely
manner a small scale Continuous Process at its Process
Development laboratory and delivered on time the Proof of Concept
study.
Slide 26
CordenPharma Continuous Process: Case Study
Based on its product knowledges and the positives outcomes of
the Proof of Concept, the pharma company (client) agreed to move
further and enter into a cooperation with CordenPharma to design
and operate a dedicated large scale Continuous manufacturing line.
CordenPharma executed all the detailed process and general
engineering studies, managed the equipment definition,
procurement and supplies, the installation and the IQ OQ PQ in a
clean room ISO 8 environment.
Slide 27
CordenPharma Continuous Process: Case Study
All these activities have been performed in close contact with the
client and in high transparency.
At date, several cGMP batches have been successfully produced
and delivered to the client.
Slide 28
CordenPharma Continuous Process: Case Study
Slide 29
CordenPharma Continuous Process:
Technology overview
In order to screen all existing Continuous Technologies ,
CordenPharma performed a comprehensive review of all the
various available technologies able to serve in a multipurpose
cGMP CDMO environment.
Key criteria for selection :
cGMP references and qualification dossier
Cleanability
Versatility
Scalability to fit with the multipurpose processes environment
Multi-phases G/L/S acceptance
Slide 30
CordenPharma Continuous Process:
Technology overview
According to this, CordenPharma is able to select the most suitable
technologies for the processes steps CordenPharma considers
appropriate to be developed as Continuous
As a matter of fact, CordenPharma has already identified in its
Request for Pricings several cases where the approach of a
Continuous Process would be definitively profitable.
It could be only one step out of the process that would best benefit to
be switched to Continuous / On line. Our approach would be just to
select it and keep the rest of the process in batch if it makes better
sense.
Slide 31
CordenPharma Continuous Process:
Technology overview
Experts taking care.
Thank you for your attention
Contact
Yves Michon
Managing Director
CordenPharma Chenôve
www.cordenpharma.com
