Laurène Haurie / GALA®, a technology platform on advanced galenic

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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

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Laurène Haurie / GALA®, a technology platform on advanced galenic

  1. 1. a technological platform dedicated to Advanced Galenic
  2. 2. Why GALA®? The pharmaceutical development Pharmaceu)cal  dosage   form  example   Auxiliary  substances   Ac)v   drug   +  
  3. 3. Pharmaceutical Development Process Drug  Discovery   Preformula2on  Research   Analy2cal  Development   Process  Research   Formula2on  Development   Bioavailability   Phisyco-­‐chemical     Characteriza2on   Pharmaceu2cal  form    concep2on   =   +   API   EXCIPIENTS  
  4. 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. 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. 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. 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. 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. 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. 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. 11. Solid dispersion (HME)
  12. 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. 13. MEB  Images   Raman  Images   Red  =  no  material   Blue  =  material   Solid dispersion (HME): Characterisation
  14. 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. 15. From liquid to powder with controled properties… Aims:     ü  Control  the  solid’s  proper2es   ü  Protec2on  with  encapsula2on   Solid dispersion (SD)
  16. 16. Aim  of  the  project:     Improve  the  flowability   Pharmaceutical product (industriel R&D project) Exemple  of  Applica3on   Solid dispersion (SD)
  17. 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. 18. •  Microspheres or Microparticules with spherical geometry and narrow granulometric distribution •  Process Comparison Prilling: Spheronisator M- Brace
  19. 19. Alimenta3on  du  noyau   Prilling: Microsphere exemples Microcapsule exemples
  20. 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. 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. 22. www.plateforme-gala.com
  23. 23. Thanks for your attention

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