custom synthesis

CUSTOMER ORIENTED
TOLL MANUFACTURING
TAILORED SERVICES
INTERACTIVE PROJECT
MANAGEMENT
CUSTOM SYNTHESIS
& API CONTRACT MANUFACTURING
CEPiA
Within the Industrial Affairs Division of Sanofi, CEPiA (Commercial & External Partnership,
Industrial Affairs) is an organization fully dedicated to third party activities. One of the key
activities of CEPiA is to offer a broad range of innovative solutions including:
• Intermediates and Active Pharmaceutical Ingredients (APIs) supply
• Custom Synthesis & API Contract Manufacturing
• Pharma Contract Manufacturing
CEPiA AT A GLANCE
• 200 CEPiA collaborators close to customers
•Around 200 APIs on catalogue…
• … sold in 80 countries
• API & Pharmaceutical CMO Services
• 30 % of Chemistry and Biotechnology industrial activities of Sanofi
CUSTOM SYNTHESIS & API CONTRACT MANUFACTURING UNDER cGMP
FOR APIs OR MULTI-STEP INTERMEDIATES
TOLL MANUFACTURING
• Pre-registered or marketed compounds
• Technical transfer of existing process and analytical
methods
CUSTOMIZED PROJECTS
•
•
NCE or NBE under clinical development:
- From phase I to launch
Process Development:
- Chemical and biotechnological development
- Analytical development
- Physical quality studies
- Clinical supplies
PILOT PLANT PRODUCTION FROM TECHNICAL /
ENGINEERING RUNS TO CLINICAL SUPPLIES
CEPiA guarantees
REACH compliance.
- Process Engineering and scale-up
- Process safety
COMMERCIAL SUPPLY AT INDUSTRIAL SCALE
QUALITY & REGULATORY SUPPORT
EXPERTISE FIELDS
CHEMISTRY
•Oligosaccharides
•Peptides
•Oligonucleotides
• Corticosteroids and Hormones
•Prostaglandins
• Opiates and opioids
• Highly Active Products (HAP)
• Multi-step heterocyclic chemistry
BIOTECHNOLOGY
•Plasmids
• Therapeutic proteins (Production / Extraction / Purification)
- Extractive proteins
- Recombinant proteins
• Monoclonal antibodies
• Viral Vectors
1 WEEK
4-6 WEEKS
2 – 4 MONTHS
TECHNICAL
IMPLEMENTATION
SUPPLY
•NON BINDING
OFFER
•CONTRACT
NEGOCIATION
CONTRACT
•REQUEST FOR
PROPOSAL
•PROJECT
ASSESSMENT
NBO
CONFIDENTIAL
DISCLOSURE
AGREEMENT
RfP
CDA
FOR A RELIABLE & LONG-TERM PARTNERSHIP
•CLINICAL
•COMMERCIAL
4 - 8 MONTHS*
*Average time frame, depending on technology
INTERACTIVE PROJECT MANAGEMENT
COMPREHENSIVE CUSTOMER SERVICE
• Project team with all relevant functions
• Efficient activities coordination
(planning optimization)
• Regular follow-up meetings to master operational
and strategic project management
• Process development and commercial
API production
• Fully integrated offer including Drug Product
and packaging
FOR THE SUCCESS OF YOUR PROJECT
COLLABORATION BASED ON RESPECT
PROACTIVE SCIENTIFIC & COMMERCIAL RELATIONSHIP
• Confidentiality and Intellectual Property
• Project timelines
•Environment a sustainable development (NYSE)
• Ethical Chart
• Sarbanes-Oxley compliance
• Proposals for potential improvements
• Flexibility and responsiveness to customers’ needs
• Life cycle management (COG improvements)
CUSTOM SYNTHESIS &
API CONTRACT MANUFACTURING
GLOBAL HEAD
SCIENTIFIC & BUSINESS
INTELLIGENCE
EUROPE & ROW
Tobias METZENTHIN, PhD
[email protected]
Tel: + 33 1 55 71 24 19
France-Emmanuelle THOLE, Ph.D
[email protected]
Tel: + 33 1 55 71 28 76
Yannick LE STANC, Ph.D
[email protected]
Tel: + 33 1 55 71 26 38
Mourad SAADY, Ph.D
[email protected]
Tel: + 33 1 55 71 20 81
Aude FAYOL, Ph.D
[email protected]
Tel: + 33 1 60 49 68 36
Arnaud MARTIN, Ph.D
[email protected]
Tel: + 33 6 76 73 30 50
Patrick CASTETS, MS
[email protected]
Tel: + 33 1 55 71 26 39
NORTH AMERICA
Bob HUANG, Ph.D
[email protected]
Tel: + 1 908 981 6969
JAPAN
Roger KRIEGL, Jr., MS, MBA, PMP
[email protected]
Tel: + 1 908 981 2512
Hikaru OHSAWA, MS
[email protected]
Tel: + 81 3 6301 3452
Alan BENSON, MS, MBA
[email protected]
Tel: + 1 908 981 5666
Chiho TADERA
[email protected]
Tel: + 81 3 6301 3450
Communication: [email protected]
www.cepia-sanofi.com
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January 2015
CHEMISTRY &
BIOTECHNOLOGY
SUSTAINABLE
DEVELOPMENT
VERSATILITY
OF EQUIPMENT
INDUSTRIAL
NETWORK
FACILITIES
AND TECHNOLOGIES
EUROPE FOCUS
Haverhill
Elbeuf
Ploërmel
Frankfurt
Antony
Ujpest
Vitry
Vertolaye
Lyon
Garessio
Mourenx
Sisteron
Aramon
Ankleshwar
Brindisi
Jurong
CEPiA’s strengths are:
•High quality standards: excellent track record with Health Authorities
•Technical experts including Process
Development and production sites
• Patents and legal representatives
• Quality Assurance and
Regulatory Affairs support
•A global purchasing policy for an
optimized supply chain of solvents
and raw materials
•Security / reliability of supply:
possibility of internal dual sourcing
•Financial stability
Our core competency is process
development in chemistry and
biotechnology. This involves:
•Development, scale-up of APIs
and intermediates processes
from route scouting, laboratory
development to kilolab and
pilot plant scale
•Technology transfers of
chemical and biotechnological
processes to production
• Optimizing commercial processes
through continuous
improvements
• Respect of cost and timelines
CHEMISTRY
BIOCHEMISTRY
BIOTECHNOLOGY
HEADQUARTERS
STATE-OF-THE-ART
PRODUCTION FACILITIES
CHEMISTRY
· Multi-purpose equipment from pilot-scale to 20 m3
· Total volume reactor > 4 000 m3
· Hydrogenations (up to 200 bar, up to 18 m3)
· Temperature range (-120 °C to 220 °C)
· Reactors in stainless steel, glass-lined, hastelloy
· Continuous reaction processes
· High vacuum product distillations (rectification/thin-film)
· Large scale chromatography (reverse phase/ion exchange)
· Centrifuges, filter-dryers, stirred pressure filters
·Finished processing of APIs (milling, micronization,
clean room packaging)
·
Examples of hazardous chemicals handled at industrial scale:
o NaN3 (azidation, tetrazole formation)
o Methylating agents (CH3Cl up to 15 bar, (CH3) 2SO4)
o Strong organometallic bases (NaNH2, LiHMDS, BuLi)
o Cyanides (NaCN, KCN)
o Hydrazine (H2N-NH2)
o In situ generated borane (BH3)
BIOTECHNOLOGY
·
BIOCHEMISTRY
Upstream process:
o Fermenters from 10 to 200 m3
o Mammalian cell culture : 400 to 10 000 L
o Plasmids: dedicated facility with 3 500 L reactor
o Vaccines: viral culture up to 1 000 L
· Downstream process:
o Biomass separation by membrane or centrifuge
technology
o Excellence in viral safety : pre-viral / post viral zoning
o Industrial chromatography (reverse phase, ion
exchange diameter)
o Filtration technologies: microfiltration,
ultrafiltration and nanofiltration
o Efficient networking with Sanofi Fill and Finish
plants (integrated offer)
CHEMISTRY & BIOTECHNOLOGY
DEVELOPMENT
CHEMISTRY
· Synthetic alternative route scouting
· Laboratory initial screening
· Scale-up from 10 mL to 20 L reactors
· Process optimization
·Definition of optimal operating procedures and critical
parameters
· Preparation of impurities : full synthesis and / or isolation
· Preparation of reference standards
· Production support:
o Process improvement
o Troubleshooting
BIOTECHNOLOGY
BIOCHEMISTRY
·
Upstream:
o Microbiology and molecular biology
o Virology: vector optimization
o Enzymology
o Fermentation
o Media Optimization
o Cell engineering and cell culture
·
Downstream:
o Extraction and filtrations
o Refolding
o Precipitation and crystallization
PROCESS ENGINEERING
· Thermal exchanges
· Material transfers
·Stirring
· Scale-up and scale-down studies
· Extraction and separation (Liquid/Liquid,
Solid/Liquid)
· Industrial chromatography
· Modelization, equipment design and piloting
· Process intensification
PHYSICAL QUALITY
·
·
·
·
Crystallization design (polymorph
and morphology screening)
Filtration and drying processes
Solid chain, milling, micronization
Powder properties determination
PROCESS SAFETY
·
·
·
Thermal analysis
Powder safety (granulometry, electrostatic
properties explosion)
Runaway reactor
PILOT PLANT BATCHES
·
·
·
·
ANALYTICAL CAPABILITIES
·
·
·
·
·
·
·
·
Development and validation of analytical methods
Structural characterization
Impurity identification, quantification and tracking
Glycan mapping, peptide mapping, identification
of aggregates
Comparability studies
Purity analysis
Stability studies
Trace analysis (organic or inorganic)
QUALITY CONTROL
·
·
·
·
In-Process-Controls (IPCs)
Testing of raw materials & APIs
Testing of standards and reference materials
Cleaning verification and validation
QUALITY ASSURANCE
& REGULATORY SUPPORT
ENVIRONMENTAL DATA
· Biodegradability of effluent
·Ecotoxicity
· Support to waste water treatment plants
Technical batches (engineering, scale-up)
Clinical supply
Primary stability
Registration (DMF)
·
·
·
·
cGMP compliance
Regulatory support for filing
Qualification of suppliers
Release of materials
Communication: [email protected]
www.cepia-sanofi.com
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January 2015
PLASMIDS AND
DNA VACCINES
ENZYMES
PROTEINS
POLYCLONAL
ANTIBODIES
BACTERIA & YEASTS
FRAGMENTS OF
ANTIBODIES (Fabs)
BIOPHARMACEUTICAL PRODUCTS (1 OF 2)
MICROORGANISM FERMENTATION & EXTRACTION
FROM INSULIN AND GROWTH HORMONE
TO BIOPHARMACEUTICAL CMO SERVICE
SANOFI
1984 Recombinant hGh
through E.Coli fermentation
GENZYME
1994
2001
2002
2006
Launch of Cerezyme®
Launch of Fabrazyme®
Launch of Aldurazyme®
Launch of Myozyme®
HOECHST
1923 Production of extractive insulin
1936 Crystallized insulin
1976 Production of semi-synthetic insulin
AVENTIS
1999
2000
2004
Recombinant insulin from
E.Coli fermentation (Insuman®)
Launch of Lantus®
Launch of Apidra®
SANOFI-AVENTIS
2005 Routine production
of recombinant urate oxidase
2009 Purification of therapeutic proteins
PRODUCTION AND PURIFICATION OF THERAPEUTIC PROTEINS AND ENZYMES:
FERMENTATION / PLANT EXTRACTION / ANIMAL ORIGIN
From the 60’s, Sanofi has been a leader in the field
of large-scale fermentation with the production
of vitamins, antibiotics and steroids. In the 80’s,
the production of recombinant proteins and enzymes
has been a pillar of growth for the company.
Fighting against Diabetes, Sanofi has become
a leader in recombinant processing through
its biosynthetic insulin business.
Moreover, Sanofi has built a large library of
microorganisms and non-natural enzymes, in order to
have access to the optimized complex molecules.
Expertise available from 3 centers of excellence:
Frankfurt (Germany): specialized in fermentation and downstream process (DSP)
Aramon (France): specialized in DSP to process natural extracts, plants, and animal milk
Lyon-Gerland (France)-(former Genzyme plant): skills and capacities to process blood derivatives
(site purifies Thymoglobulin from blood cells)
Our upstream expertise covers:
•Strain building and optimization
(molecular biology team in FrankfurtGermany)
•Master cell bank cGMP production
and storage
•High density fermentation up to 55 m3
•High throughput cell disruption
techniques
•Inclusion body technology
(processing, refolding)
Our downstream expertise covers:
•Isolation techniques of a broad
range of solutes and solids:
continuous centrifugation,
filtration, drying
•Process scale-up using in-house
know-how and tools
•Large scale low to high pressure
chromatographic techniques for the
purification of proteins (glycosylated,
multimeric)
Continuous process and cost improvement using latest innovation (combining stainless steel and disposable equipment)
A broad range of services to achieve your success:
•Biosafety risk assessment done by viral experts
•Fill & finish facilities to offer one-stop-shop (liquid and lyophilized vials, injectable syringes)
THERAPEUTIC PLASMIDS
& DNA VACCINES
Sanofi has an unique expertise with creation, production
and purification of plasmids through in-house program.
One compound completed international phase III studies:
INDs and IMPDs submitted and drug substance validation
completed.
State-of-the-art workshop located in Frankfurt (Germany)
is equipped with several trains of fermentation up to
3 500 L with associated downstream process (DSP).
Upstream process :
•Cell banking: master cell bank,
working cell bank
• High cell density fermentation
Downstream process :
• Specific equipment for continuous
cell lysis
• Expertise in the purification of
plasmids at large scale
•Technology available for
the affinity chromatography
of plasmids
Specific technology and
plasmid design:
•Sanofi patented pCOR
technology
•Batch size: 30 / 40 g
•High number of copies
• No antibiotic resistance gene
• Insertion of multimer
resolution gene
Example of a plasmid
developed in-house:
•Double stranded circular DNA
•Supercoiled form
•Size: 1.5 million Dalton
Contract manufacturing
services offer:
•cGMP batches from preclinical phase to
commercial scale
•Transfer of customer’s
process and analytical
methods
• Fill & finish facilities
•Specific analytical
expertise
(to characterize and
release material)
CONTACTS
MICROORGANISM FERMENTATION & EXTRACTION
Europe:[email protected]
[email protected]
USA:[email protected]
Japan:[email protected]
Communication: [email protected]
www.cepia-sanofi.com
arcangelegroupe.com |433 527 090 00032 - 02 76 30 58 70 - © photos : SANOFI, Alexis Chézière - Document imprimé par un imprimeur labellisé Imprim'Vert, sur papier FSC recyclé avec des encres végétales.
January 2015
PERFUSION
& FED-BATCHES
CHIMERIZATION
AND HUMANIZATION
MAbLaunch™
mAbs
CHO CELLS
INTERLEUKINS
In a worldwide competitive and
fast evolving environment, startup pharmaceutical and biotech
companies need flexibility. Taking
advantage of historical success,
CEPiA offers to its customers a
flexible and innovative solution
to achieve success with their biologics projects, from development
to commercialization.
BIOPHARMACEUTICAL PRODUCTS (2 OF 2)
MAMMALIAN CELL CULTURE
A FULLY INTEGRATED ORGANIZATION TO PRODUCE
MONOCLONAL ANTIBODIES & THERAPEUTIC PROTEINS
FROM MAMMALIAN CELL CULTURE
Sanofi offers biomanufacturing services from clinical phases
to commercial scale:
•Expression vector construction
•mAb chimerization and humanization
•Cell line development
•Biosafety risk assessment done by viral experts
•Strong analytical background with sophisticated glycosylated proteins
•Full range of analytical and regulatory support
•Fill & finish facilities to offer one-stop-shop
Development and production of monoclonal antibodies
and therapeutic proteins from two facilities.
CAPI organization (Frankfurt, Germany) from early phase
to phase III:
•66 technical experts for development of mAbs
processes and analytical for in-house and
customers purpose
•Perfusion and fed-batches
•Disposable and stainless steel bioreactors from 20 L to 2 500 L
•Purification column from 20 cm to 60 cm
•Excellent track records
• Successful transfer of processes and analytical methods
• Analytical expertise to characterize proteins
and release cGMP batches
BioLaunch organization co-located with Process Development
(Vitry-sur-Seine, France): from phase III to commercial batches
•60 scientists and technicians
•recently built state-of-the-art facility dedicated to mammalian
cells bioproduction
•3 modular stainless steel trains
•2 separate seed trains from 100 L up to 3 000 L
•1 bioreactor of 2500 L and 3 bioreactors of 10 000 L based on
fed-batch processing
•broad range of associated downstream process (DSP) to
achieve purification of mAbs
Through MabLaunchTM
initiative, LFB &
Sanofi combine
their bioproduction
capabilities to offer
integrated CMO
services from cell
line development to
commercial scale
including clinical
batches.
CONTACTS
MAMMALIAN CELL CULTURE
Europe:[email protected]
USA:[email protected]
Japan: [email protected]
VITRY-SUR-SEINE (FRANCE)
Communication: [email protected]
www.cepia-sanofi.com
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January 2015
GENE THERAPY
SANOFI PASTEUR
THERAPEUTIC VACCINES
VIRAL VECTORS
VIRAL VECTORS
FOR GENE THERAPY AND VACCINES APPLICATIONS
MERIAL
GENCELL 1998
© photos : LBC – Microscopie Electronique, Université François Rabelais, Faculté de Médecine et CHRU de Tours
GENZYME
Sanofi has been a pioneer in the field of Gene therapy in the 80s’ through
Gencell organization developping Viral Vectors. Sanofi through its vaccines
division has a successfull history in virus production with launch of a large
number of vaccines based on viruses.
CEPiA offers its services to produce Viral Vectors through its Sanofi Pasteur
and Genzyme divisions.
Sanofi team, with 20 years of experience, is a leading company in the production of viral vaccines (wild type or recombinant virus) and viral vectors.
CEPiA offers a broad range of services such as, cell and
virus banking, process scale-up to commercial scale
manufacturing with various technologies (static culture,
dynamic culture in single use bioreactors up to 1000 L).
Lyon (France) a cluster of
excellence to support external
partners’ projects:
•Experts in Virology for vector
optimization
•Upstream and downstream process
excellence based on mammalian
cell culture (suspension and
adherent cell line on microcarriers),
viral culture for vaccines production
•Engineering teams worldwide,
working in close cooperation with
equipment manufacturers
•Global knowledge management
to implement the most recent
technical innovations
•Analytical and regulatory services
•Fill & Finish facilities
Broad range of products upon request :
- Adenovirus
- Recombinant adeno-associated virus (rAAV)
- Sendaï virus
- Modified Ankara virus (MVA)
- Lentivirus
The teams, located in Lyon (France), have a significant
track record and have a successful and diversified
experience in process and analytical transfers.
Sanofi Pasteur and Genzyme collaborate to establish
a seamless project management.
A new industrial platform in Lyon (France) combining
expertise from Sanofi Pasteur and Genzyme is under
construction and will be operational in 2015:
- 1200 m²
- different technologies available:
• CEF (chicken embryo fibroblast) cell culture
• mammalian cell culture
- techniques: cell factories, roller-bottles, single use
bioreactors up to 1 m3
CONTACTS
Viral Vectors
Europe:[email protected]
USA:[email protected]
Japan:[email protected]
Communication: [email protected]
www.cepia-sanofi.com
arcangelegroupe.com |433 527 090 00032 - 02 76 30 58 70 - © photos : SANOFI - Document imprimé par un imprimeur labellisé Imprim'Vert, sur papier FSC recyclé avec des encres végétales.
January 2015
INNOVATIVE PLATFORM
SCIENTIFIC EXPERTISE
STATE-OF-THE-ART
EQUIPMENT
PEPTIDES
& OLIGONUCLEOTIDES
LIQUID & SOLID
PHASE CHEMISTRY
Our "Tides" Platforms are embedded
in state-of-the-art infrastructures on
2 industrial sites:
•Haverhill (United Kingdom)
•Frankfurt (Germany), one of the
largest industrial chemistry and biotechnology site.
CEPiA offers customized services
(manufacturing and analytical)
from clinical phase to submission
and launch (grams scale up to kilograms quantities), including regulatory support, as well as commercial
supplies.
cGMP API manufacturing can be
combined with Drug Product and
Devices technologies.
Our facilities are regularly inspected
by Health Authorities, including FDA,
EMA and PMDA.
PEPTIDES DEVELOPMENT
AND PRODUCTION
Clinical Trial
Quantities
Commercial
Batches
Process
Development
Pilot Synthesizer
10-80 L
Production
Plant
Synthesizer 280 L
Cleavage
& Precipitaion
Production
Plant
Production
Plant
Purification
Chromatography
300/350 mm
columns (lEx, RP)
Chromatography
columns (lEx, RP)
in industrial network
Isolation
Lyophilizers
(10 Kg + 40 Kg ice)
Lyophilizer
(100 Kg ice)
Solid Support/Resin
Synthesis
Resin + Peptide
Crude Peptide
Chromatography 1
Chromatography 2
• Solid phase peptide synthesis
(10 - 280 L)
Vacuum - Distillation
Lyophilization
Pure Peptide
• Liquid phase peptide synthesis
and synthesis of intermediates
(50 - 600 L)
Through Sanofi’s 25 years experience in the field of
oligonucleotides, CEPiA can provide different
classes of Oligonucleotides such as DNA,
2’-O-Modified, phosphorothioate derivatives.
OLIGONUCLEOTIDES
DEVELOPMENT
AND PRODUCTION
Solid Support
Synthesis
Oligonucleotide/
Support
Oligonucleotide
Solution
Chromatography
Ultra-filtration
Deprotection
& Cleavage
Production
Plant
Oligo process
Synthetizer up
to 600 mmoles
scale of crude
Oligonucleotide
(“Oligo Process”
with 12 independent
amidite ports)
Full analytical service:
- Structural characterization
- Development of analytical methods
- QC testing for batch release
- Full scope of analytical studies
needed for filing
Solvent supply lines, storage areas
and waste management are
designed according to the latest
European standards.
Purification
Desalting &
Concentration
Chromatography
in industrial network
CONTACTS
Lyophilization
Pure
Oligonucleotide
Isolation
Lyophilizers
TIDES
Europe:[email protected]
USA:
Peptides
[email protected]
Oligonucleotides
[email protected]
Japan:[email protected]
Communication: [email protected]
www.cepia-sanofi.com
arcangelegroupe.com |433 527 090 00032 - 02 76 30 58 70 - © photos : SANOFI - Document imprimé par un imprimeur labellisé Imprim'Vert, sur papier FSC recyclé avec des encres végétales.
January 2015
SYNTHETIC
HEPARINOÏDS
200 CHEMICAL
STEPS DEVELOPED
20 YEARS
EXPERTISE
OLIGOSACCHARIDES
WORLDWIDE
LEADER
Sanofi has been involved in oligosaccharide chemistry since the
90’s and is recognized as a worldwide leader in API manufacturing
in this field.
Amongst this family of very active
anti-thrombotic derivatives, Sanofi
developed and marketed semisynthetic or fully synthetic heparinoïds.
For the fully synthetic oligosaccharides, Sanofi has developed
complex molecules which manufacture requires a high number of
chemical steps (up to 80 chemical
steps).
For the projects, we develop a synergetic approach using a common
building-blocks strategy based on
our worldwide industrial network.
Main advantages:
• Minimize the number of chemical
intermediates
• Reduce lead time
• Increase security of supply
• Optimize cost of goods.
More than 200 chemical steps have been
developed by our teams and more than 100
experts have been involved to ensure a high level
of performance on this very specific chemistry
being able to manage even at production scale:
•Activation of oligosaccharides throughout
trichloroacetimidates, thioglycosides
•Coupling reactions (glycosylations):
- stereoselective & stereospecific reactions
- low temperature (down to -50 °C at production
scale)
- anhydrous conditions (water contents below
10 ppm)
In addition, our analytical department fully supports
these development activities with:
•Orthogonal protection/deprotection strategy
• Chromatography techniques (HPLC, GC, IC, CE) with
specific detection for molecules without UV absorption
•Specific expertises in:
- azidation
- hydrazine handling
• Mass spectrometry (Q-TOF, TOF, Ion-trap) and NMR
(500 MHz and 300 MHz) to elucidate very complex
chemical structures
TOOLS - FACILITIES
Laboratories for oligosaccharide
synthesis and analysis
• Kilolab facilities for productionof small
scale batches to support phase I to
phase III clinical studies
• Kiloprep facilities for normal, reverse
phase chromatography: Prochrom
systems (50 to 300 mm)
• Pilot plant and production facilities:
from 50 L to 6 000 L
• Ion exchange dedicated purification
facilities from grams to kilograms of APIs
CONTACTS
OLIGOSACCHARIDES
Europe:[email protected]
USA:[email protected]
Japan:[email protected]
Communication: [email protected]
www.cepia-sanofi.com
arcangelegroupe.com |433 527 090 00032 - 02 76 30 58 70 - © photos : SANOFI - Document imprimé par un imprimeur labellisé Imprim'Vert, sur papier FSC recyclé avec des encres végétales.
January 2015
OEB 5 COMPOUNDS
OUTSTANDING
FACILITIES
ISO 7
CLASSIFICATION
HIGHLY SKILLED
TEAMS
CEPiA offers to customers to have
their Highly Active Product (HAP)
projects handled by the same experts who developed and manufacture the two marketed drugs:
Docetaxel (Taxotere ®) and Cabazitaxel (Jevtana ®)
HIGHLY ACTIVE
PRODUCTS
Our high level of expertise acquired through solid and
long lasting experience in handling cytotoxic compounds
is strongly set on five principles:
• Extensive knowledge in Chemistry
• State-of-the-art facilities
• Highly trained team
• Environment, Health and Safety experts
• High standards in quality
We are committed to sharing our scientific knowledge and experience
in pharmacology and toxicology to support your project.
Our internal team of experts in industrial hygiene can assess OEB* categorization for APIs
and upstream intermediates only when necessary to minimize costs.
We apply the OEB* index from 1 to 5 relative to the product toxicity.
OEB* index corresponds to an OEL** range (see the following table).
OEB*
OEL** Range (µg/m3)
OEB 1 1 000 - 5 000
OEB 2 100 - 1 000
OEB 3 10 - 100
OEB 4 1 - 10
OEB 5 < 1
In addition, Sanofi has the highly specialized ability to handle
HAPs with a single-digit nanogram/m3 exposure limit. We have
qualified several of our isolators to satisfy recent requirements.
*OEB: Occupational Exposure Band
**OEL: Occupational Exposure Limit
Our facilities for highly active compounds
manufacturing are located near Paris (France),
operated under cGMP procedures and are governed
by Sanofi Quality Control.
On the same site, two production units are suitable
for technical transfer and process development,
small scale production and large industrial scale
manufacturing.
These two units are operated in ISO 7 classification
for OEB 4 and OEB 5 compounds and are regularly
inspected by Health Authorities, including FDA,
EMA & PMDA.
All the production lines are equipped with the latest
technologies in isolators, glove boxes, vessels and
drying equipment. Machinery is fully or partially
segregated with air control systems satisfying
the most stringent requirements for product and
personnel protection.
Our volume range is 5 - 1 000 L reactors in stainless
steel, hastelloy and glass-lined for a total of 39 reactors
(total volume of 10 m3).
Upon request, we provide milling and micronization
services for HAP in ISO 7 room.
The total staff is nearly 80, working in one or two shifts.
Highly trained personnel are recognized for their
ability to work meticulously and safely in contained
environment.
CONTACTS
HAP
Europe:[email protected]
USA:[email protected]
Japan:[email protected]
Communication: [email protected]
www.cepia-sanofi.com
arcangelegroupe.com |433 527 090 00032 - 02 76 30 58 70 - © photos : Jean Chiscano - Document imprimé par un imprimeur labellisé Imprim'Vert, sur papier FSC recyclé avec des encres végétales.
January 2015