DEVELOPMENT

New developments

We can carry out the development of your products in the following formats:

  • Dry forms
  • Sachets
  • High Potent
  • Oral lyophilisate

We have the needed facilities for the realization of pilot and clinical batches on our sites of Galien Macors Auxerre and Galien LPS Nevers.

Pilot Unit

Installed on the Galien LPS Nevers site, a pilot unit with dedicated team allows the accelerated development of new lyophilized oral tablets LyoDis® before industrialization:

  • Manufacturing of small batches up to 50 liters of mixture and a few thousand tablets dosed from 1µg to a few grams of active ingredients
  • Packaging of small series under PVC, PVC / PVDC or Alu coldform
  • Launch of the first pre-formulation studies, from formulation to stabilization of the pilot batches.

Quick to market

Our experts will also help you to transfer already existing molecules to a lyophilized oral form for additional range. Examples :

  • Peptides
  • Protein
  • Orphan specialty molecules

Our business objectives are plural :

  • Minimize development costs
  • Reduce development and industrial transfer times
  • Be the first to submit a case (first to file – FDA 505b2)