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DRUG DELIVERY SOLUTIONS
DRUG PRODUCT DEVELOPMENT
CLINICAL SUPPLIES
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SUMMARY
Mission and values
History and group structure
Galenix integrated services
Quality standards
Galenix Innovations Galenix Development Galenix Pharma
Business opportunities
Mission and values
Galenix provides a range of full R&D
pharmaceutical services and Drug
Delivery Solutions to health
companies for fast access of their
products on the market
PHOTO
From the sourcing of the API through the
development process including formulation,
stability, quality control, clinical supplies and
regulatory file submission,
Galenix provides its customers with “ready to
launch” drug products holding a Marketing
Authorization

History
1993 : Galenix was founded to develop drug products, in close cooperation with the
University of BORDEAUX II - FRANCE
1995 : Quality control department
1998 : Regulatory affairs department
2000 : Strategic intelligence, innovative DDS and patents constitute the new research structure
Galenix Innovations
2006 : Acquisition of the Saint-Nazaire B.M.S. Pharmaceutical Research Institute
by Galenix Pharma
2007 : Authorization for GMP manufacturing and import of drug products AFSSAPS # F07/32
GMP Europe
and US FDA
Saint-Nazaire
Saint-Jean d’Illac
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Group structure
Highly qualified staff of 90
Galenix
Galenix
Galenix
Innovations
Développement
Saint-Jean d’Illac (Bordeaux)
Galenix Pharma
Galenix
Inc
Saint-Nazaire
New York
(Nantes area)
(USA)
Galenix
Biotech

Integrated services

Quality standards
ISO 9001 version 2000 compliance - BVQI
First French R&D company certified in year 2000
GMP Europe and US FDA standards
Authorization for GMP manufacturing and import of drug products AFSSAPS # F07/32
For Galenix Pharma

Galenix Innovations
Strategic intelligence
Worldwide technology and market surveys
Innovative Drug Delivery Solutions
6 patented DDS and more than 10 patents on compositions
Patents strategy and management
Worldwide patents
Feasibility studies
Assessment of compatibility API/DDS
Licensing out
Licensing out to pharmaceutical companies

Galenix Patented DDS
Several patent families around 6 patented technologies
MINEXTAB®
MINEXTAB® Floating
MICROGIX®
Patient’s compliance, improved formulations,
Life Cycle Management

Galenix Patented DDS
Several patent families around 6 patented technologies
MUCOLYS® Film
MUCOLYS® Flash
ODTx®
Patient’s compliance, improved formulations,
Life Cycle Management

Galenix Development
Formulation
All dosage forms, optimization of manufacturing process and composition
Analytical development and validation
Special automated equipment
Technology transfer team
Worldwide scale-up and analytical transfers
Conventional development or improved formulation
with patented DDS

Preformulation, formulation, scale-up
Dry dosage forms
TABLETS - multi-layers,
immediate or sustained release,
mucoadhesive, effervescent
PELLETS, CAPSULES
TASTE MASKING
FILM FORMING POWDER
FLASH RELEASE POWDER
Galenix Development
Injectable and
oral dosage forms
DRUG DELIVERY SYSTEMS
SOLUTIONS
SUSPENSIONS
IMPLANTS
LIQUID AND PASTY FORMS
TASTE MASKING
Topical forms
EMULSIONS, MICROEMULSIONS
Spray dosage forms
GELS - thermoreversible, bioadhesive
OPHTALMIC, VAGINAL forms
DRY and LIQUID
TRANSDERMAL and
TRANSMUCOSAL systems
PATCHES

Characterization of API’s
Analytical development and validation
HPLC /
UV, visible, ionic,
refractometry,
fluorimetry
GC / FID
Microscopy
Laser Granulometry
Galenix Development
Differential
scanning
calorimetry
In Vitro Dissolution / off
line, on line
(USP type II and III)
Zymark automation
In Vitro permeation on
Franz cells
for topical forms
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Galenix Development
Product development highlights
 More than 40 Marketing Authorizations granted in 14 years
 New Chemical Entities, line extension and generic products

Galenix Pharma
GMP Europe and US FDA facilities
Stability studies
Quality control
Import QP release
Clinical supplies
QP release of GMP Batches
Regulatory Affairs
Global IT support

Galenix Pharma
Stability studies
- ICH standards
API’s, finished products, all types of containers,
including semi-permeable containers
Climatic zones I, II, III, IVa, IVb
- Other stress conditions
Photo-stability UV and Visible
Cyclic temperature conditions from -15°C to +40°C
21 CFR Part 11 environment for data acquisition
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Galenix Pharma
Quality Control
- Pilot batches
- Clinical batches
- Commercial batches
- Imported medicines
►Q.P. release
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Galenix Pharma
Import
- Bulk, semi-finished
- Finished products
- Pharmaceutical specialties for the European
market
- Pharmaceutical specialties, other drug
products for clinical batch production
►Q.P. release
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Galenix Pharma
Analytical Equipment
- 19 HPLC Alliance Waters, Agilent, GC
-13 dissolutests UV/Visible on line, off line
- IR spectrophotometer Perkin Elmer Nicolet 380
- NIR spectrophotometer Thermo Fisher
Nicolet Antaris II and Nicolet Antaris target
- 2 automated dissolutests Multidose Plus Zymark-Vankel
- 2 automated equipment for samples prep. Zymark TPWII
- Karl-Fisher Titrino with Metrhom sampler
- Potentiometer Mettler Toledo
…. And more ….
21 CFR Part 11 environment
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Galenix Pharma
Clinical supplies
 Manufacturing
- Dosage forms
- Blinding into capsules
- Manufacturing equipment
 Packaging
- Primary packaging
- Clinical batches final packaging
 Distribution

Galenix Pharma
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Manufacturing
- Dosage forms
• SOLID dosage forms
tablets (plain, coated, multi-layer), capsules, powders, sachets, pellets
(1 kg to 150 kg)
• LIQUID and SEMI-SOLID dosage forms (max 500 l)
GMP
Europe and US FDA standards in the same facilities
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Manufacturing
Galenix Pharma
- Manufacturing equipment
Examples:
Fluid bed dryers
Vector FLN 30
Glatt GPCG1
BSI blenders
2,5 l, 10 l, 15 l, 75 l, 150 l, 250 l
Roue Rohn blenders TE 650
3 l, 5 l, 10 l, 20 l, 30 l, 35 l
Wet granulation
Colette Gral 75
Aeromatic Fielder PMA 1
Lödige M5R, M20R, FM50
Dry granulation
Roller compactor Alexanderwek
WP120
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Manufacturing
Galenix Pharma
- Manufacturing equipment
Tablet machines
Killian S100
Frogerais MR6
Manesty tri-layers LP39
Coating equipment
Hi Coater Vector VHC 1355
Hard caspsules filling
Macophar MT5, MT13
Bosch GKF 400
Liquid/ semi-solid vessel
SOGEVAL 500 l
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Manufacturing
Galenix Pharma
- Blinding into capsules
- Formulation development
- Macophar MT5, MT13, Bosch GKF 400, Bonapace BB6
- Comparative In Vitro dissolution testing
- Analytical methods development and validation
- Stability studies
- DBcaps ® or Coni-Snap ®
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Packaging
Galenix Pharma
- Clinical batches final packaging
Labelling
- Multi-lingual labels design and printing, boolklet labels, codebreak enveloppes, randomization list
Patient Kits
- Blister-cards design suitable for ambulatory clinical trials
- Patient kits design in accordance with the study protocol
• Kits labeling and assembly
►Q.P. release
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Galenix Pharma
Distribution
- Clinical Trials Units shipment to Europe and
Worldwide
- Room and controlled temperature (+2 +8°C)
- Carrier selection according to several criteria
(delivery place, quantity, deadlines, storage
conditions, nature of the products)
- Returns
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Galenix Pharma
Global IT support
- Stability
- QC
- Production
 HB mesure
 Applied Biosystems V06 - LIMS
 CAPM PMX Rockwell Automation
21 CFR Part 11 environment
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Galenix Pharma
Pharmaceutical Affairs
- Coordination of Phase I clinical studies
Partnerships with more than 10 C.R.O.
in Europe and worldwide, and
laboratories
- IMPD, IND, pre-IND meeting, etc.
- Regulatory Consulting
- Marketing Authorization Application
C.T.D., ANDA, NDA, compiling and
Submission on customer’s behalf or
Galenix’s
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Business opportunities
Galenix
Comprehensive pharmaceutical services
from the API selection to the marketed drug product
 GMP EUROPE and US FDA standards on the Technologies platform
 Innovation: NEW Drug Delivery Solutions
 Accelerated development timelines
 Quality standards ISO 9001 and GMP
 Customization of services

Thank you for your attention
GALENIX INNOVATIONS
&
GALENIX PHARMA
GALENIX INC
GALENIX DEVELOPPEMENT
Allée des Palanques
Rond Point de Brais
33 127 St Jean d’Illac - France
Rte St André des Eaux
44600 St Nazaire - France
Tel : +33(5) 56 68 83 00
Tel : +33(2) 51 10 30 00
Fax : +33(5) 56 68 83 01
Fax : +33(2) 51 10 20 19
[email protected]
60 Broad Street
NY-10004 New York - USA
[email protected]
[email protected]
www.galenix.fr
