Presentation given by Laurène Haurie from Plateforme Gala in the framework of the Emergence Forum Barcelona Biocat organized the Barcelona Emergence Forum (April 10-11th, 2014, Congress Palace, Montjuïc) supported by the TRANSBIO SUDOE, a translational cooperation project dedicated to innovation in life sciences in South-West Europe. The Barcelona Emergence Forum contributed to bringing together Academics, Companies, Investment Entities, Technology Platforms and Technology Transfer Offices from Spain, France and Portugal to set up collaborative projects on Human Health & Agro-food Innovation. More information at: http://www.b2match.eu/emergenceforum2014

1. a technological platform dedicated to
Advanced Galenic

2. Why GALA®?
The pharmaceutical
development
Pharmaceu)cal
dosage
form
example
Auxiliary
substances
Ac)v
drug
+

3. Pharmaceutical
Development Process
Drug
Discovery
Preformula2on
Research
Analy2cal
Development
Process
Research
Formula2on
Development
Bioavailability
Phisyco-­‐chemical
Characteriza2on
Pharmaceu2cal
form
concep2on
=
+
API
EXCIPIENTS

4. Pharmaceutical dosage
forms
~ 40% of pharmaceutical
products never reach the
clinical level due to a bad
absorption by the human
body
Increasing difficulty since
last 15 years
REASONS
FOR
DRUG
FAILURE

5. Why GALA®?
Advanced Galenic is seen as a market of
major importance in the field of drug
delivery
Engineered particle
for drug delivery
The galenic improvement of the existing
products also constitutes one possibility
to avoid the high cost of the
development of new molecular entities.

6. What is GALA®?
1. A network of competences
Chemical
synthesis
Physico-­‐chemistry
of
powders
Galenic
formula2on
Processes
engineering
Physico-­‐chemistry
of
colloidal
systems
SPCMIB
UMR
CNRS
5068
LGC
UMR
CNRS
5503
CIRIMAT
UMR
CNRS
5085
RAPSODEE
UMR
CNRS
5302
IMRCP
UMR
CNRS
5623

7. GALA®,
an
Advanced
Galenic
Technology
PlaSorm
Associated laboratories:
• RAPSODEE, UMR CNRS 5302
• CIRIMAT, UMR 5085 CNRS/INPT/UPS (Equipe PPB)
• LGC, UMR 5503 CNRS/INPT/UPS
• I.M.R.C.P., UMR 5623 CNRS/UPS (Groupe S.M.O.D.D.)
• LSPCMIB , UMR 5068 CNRS/UPS
Other funding members:
• Communauté d’agglomération de Castres-Mazamet Technopole

8. What is GALA®?
dedicated
equipment
and
lab
space
for
manipula3on
of
API
in
compliance
with
safety
rules
and
in
GMP
condi3ons
• Laboratories
area
-­‐ 1
area
for
small
equipments
-­‐ 1
area
for
analysis
and
characterisa3on
• Area
for
produc2on
-­‐
2
pilot
areas
2. An innovative infrastructure
•
Development
of
oral
dosage
forms
•
Development
of
monodispersed
microcapsules
•
Characterisa2on
of
pharmaceu2cal
dosage
forms

9. §
Laboratory
Area
I
(42
m2)
§
Laboratory
Area
II
(29
m2)
§
Weight
Area
(5,2
m2)
§
Laundry
(5
m2)
§
Storage
Area
(12
m2)
§
Pilotes
Areas
ISO
7
(29
m2;
36
m2)
§
Weight
Areas
ISO
7
(6,2
m2;
4,4
m2)
§
Equipments
Storage
Area
ISO
8
(11m2)
§ Laundry
ISO
8
(
11m2)
Technical
center
in
CASTRES
Plateforme
GALA
®
:
innova3ve
equipments
available
to
experiment
and
characterize
processes
and
materials
and
manipulate
pharmaceu3cal
ac3ve
drugs
in
safety
condi3ons
What is GALA®?

10. Innovative
technologies in galenic
• Hot-­‐Melt
Extrusion
Line
in
GMP
configura3on
• Prilling
microencapsula3on
machine
(from
liquid
phase)
• Spray
Dryer
• Raman
confocal
–AFM
Microscope
CHARACTERISATION MEANS
PROCESSES
Spheronisator M
BRACE
Extrudeuse Pharma 16
THERMOFISHER
Atomiseur de séchage
B-290 - BUCHI
Microscope Alpha 300AR
WITEC
10
21/02/201
4
What is GALA®?

11. Solid dispersion (HME)

12. Modular
concept
with
screw
and
Sheath
Flow:
0,5
to
5
kg/h
Gravimetrics
Feeders:
Flexwall
single
screw
;
flow
from
0,5
to
10
kg/h
MiniTwin
twin
screw;
flow
from
0,05
to
2,5
kg/h
Twin
screw
Extruder
Pharma
16
Thermofisher
Solid dispersion (HME)

13. MEB
Images
Raman
Images
Red
=
no
material
Blue
=
material
Solid dispersion (HME):
Characterisation

14. Spray drying
From
liquid
…to
powder
...
In
few
seconds!
Ini3al
state:
liquid
product
(‘pumpable’
product)
Final
State:
pulverulent
product
(powder
with
uniform
quality)
Solid dispersion (SD)

15. From liquid to powder with
controled properties…
Aims:
ü Control
the
solid’s
proper2es
ü Protec2on
with
encapsula2on
Solid dispersion (SD)

16. Aim
of
the
project:
Improve
the
flowability
Pharmaceutical product (industriel R&D project)
Exemple
of
Applica3on
Solid dispersion (SD)

17. Diagram of the liquid flow through an opening,
function of the speed flow
PRILLING SPRAY DRYING
Vitesse du jet
laminaire turbulent
Prilling
Diagram of the
Prilling principle

18. • Microspheres or Microparticules with spherical
geometry and narrow granulometric distribution
• Process Comparison
Prilling:
Spheronisator M- Brace

19. Alimenta3on
du
noyau
Prilling:
Microsphere exemples
Microcapsule exemples

20. GALA®: scientific
meetings
Meeting Place and exchange between Academic world
and industrials actors
1st
MEETING
(déc
2009)
–
théma2c
workshop
• Formula3on/Galénic/
Coa3ng/Encapsula3on
• Analyse
and
Characterisa3on
2nde
MEETING
(déc
2011)
How
to
improve
the
biodisponibility
of
the
bioac3ves
molecules
few
soluble
in
aqueous
solu3on
?
From
the
molecule
to
the
drug
:
Part
of
genera3on
and
shaping
of
solids
3rd
MEETING
(june
2013)
Co-­‐organised
with
the
SFGP
Solides
Divisés
group
17&18
APRIL
2013
GALA&WITEC
Days
Confocal
Raman-­‐AFM
Microscopy
05
APRIL
2013
APGI
–
SANOFI
–
GALA
Day
Industrial
Drying
23&24
APRIL
2014
2nd
GALA&WITEC
DAYS
Confocal
Raman-­‐AFM
Microscopy

21. ü
A
network
of
competences
in
innova3ve
galenic
that
gathers
various
laboratories
with
complementary
exper3se
and
that
relies
on
an
equipped
new
laboratory
dedicated
to
the
manipula3on
of
ac3ve
pharmaceu3cal
ingredients...
There
is
no
other
exis2ng
Galenic
Technology
PlaSorm
of
this
type
(market
survey
performed
by
ALCIMED,
April
2009)
ü
A
support
plakorm
of
the
Cancer-­‐Bio-­‐Santé
Cluster
in
Midi-­‐Pyrénées
(project
labelled
in
April
2009)
In
summary,
is

22. www.plateforme-gala.com

23. Thanks for your attention