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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
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Mission and values
Galenix provides a range of full RD
pharmaceutical services and Drug Delivery
Solutions to health companies for fast access of
their products on the market
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
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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-Jean dIllac
Saint-Nazaire
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Group structure
Highly qualified staff of 90
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Integrated services
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Quality standards
ISO 9001 version 2000 compliance - BVQI First
French RD 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
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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
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Galenix Patented DDS
Several patent families around 6 patented
technologies
MINEXTAB
MICROGIX
MINEXTAB Floating
Patients compliance, improved formulations,
Life Cycle Management
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Galenix Patented DDS
Several patent families around 6 patented
technologies
ODTx
MUCOLYS Flash
MUCOLYS Film
Patients compliance, improved formulations, Life
Cycle Management
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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
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Galenix Development
Preformulation, formulation, scale-up
Dry dosage forms
Injectable and oral dosage forms
TABLETS - multi-layers, immediate or sustained
release, mucoadhesive, effervescent PELLETS,
CAPSULES TASTE MASKING FILM FORMING POWDER FLASH
RELEASE POWDER
DRUG DELIVERY SYSTEMS SOLUTIONS SUSPENSIONS IMPLAN
TS LIQUID AND PASTY FORMS TASTE MASKING
Topical forms
Spray dosage forms
EMULSIONS, MICROEMULSIONS GELS -
thermoreversible, bioadhesive OPHTALMIC, VAGINAL
forms TRANSDERMAL and TRANSMUCOSAL systems PATCHES
DRY and LIQUID
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Characterization of APIs Analytical development
and validation
Galenix Development
HPLC / UV, visible, ionic, refractometry,
fluorimetry GC / FID
In Vitro Dissolution / off line, on line (USP
type II and III) Zymark automation
Differential scanning calorimetry
In Vitro permeation on Franz cells
for topical forms
Microscopy Laser
Granulometry
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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

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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
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Galenix Pharma

• - ICH standards
• APIs, 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 -15C to 40C

Stability studies
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

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Galenix Pharma

• 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)

PLACEBO or ACTIVE drug product
GMP Europe and US FDA standards in the same
facilities
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• Manufacturing
• - Manufacturing equipment

Galenix Pharma
Examples
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
Fluid bed dryers Vector FLN 30  Glatt
GPCG1 Wet granulation Colette Gral
75 Aeromatic Fielder PMA 1 Lödige M5R,
M20R, FM50 Dry granulation Roller compactor
Alexanderwek WP120
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• Manufacturing
• - Manufacturing equipment

Galenix Pharma

• 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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Galenix Pharma

• Manufacturing
• - 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
• - Clinical batches final packaging

Galenix Pharma

• Labelling
• - Multi-lingual labels design and printing,
  boolklet labels, code-break 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 8C)
• - 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 customers
behalf or Galenixs
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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

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Thank you for your attention
GALENIX INNOVATIONS GALENIX DEVELOPPEMENT
GALENIX INC
GALENIX PHARMA
Allée des Palanques 33 127 St Jean dIllac -
France Tel [phone] Fax 33(5) 56
68 83 01 galenix_at_galenix.fr
Rond Point de Brais Rte St André des Eaux 44600
St Nazaire - France Tel [phone] Fax
33(2) 51 10 20 19 galenix_at_galenix.fr
60 Broad Street NY-10004 New York -
USA galenix_at_galenix.fr
www.galenix.fr
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