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Update of Drug Master File (DMF)
Industrial production of API for market needs.
Further stability testing.

Step 5 Clinical trial phase 3

Process validation.
Stability studies.
Update of CMC.

Step 4 Clinical trial phase 2

Forced degradation study : identification of significant impurities.
Investigational stability study.
Reference standard synthesis of API: Analytical qualification.
Validation of analytical methods (monograph)

Step 3 Clinical trial phase 1

Specifications of API and raw materials.
GMP production for first in man clinical trials.
First analytical protocols for critical step of synthesis.
Qualification of API analytical methods.
First stability studies of API.
CMC (chemistry manufacturing and controls) preparation pour IND and IMPD

Step 2 Preclinical studies

Peptide characteristics: solubility studies, chemical and physical properties, conditions of purification and drying.

Step 1 Feasibility studies

Synthesis route studies and manufacturing processes
Process development to define an economical and scalable process
Development of first analytical method, chemical analysis, and structure determination for the peptide API

Know – How

Specialist

Of the chemical synthesis of long and /or complex peptides
Of synthetic vaccines development

Own R & D

In Peptide chemistry
In New synthetic vaccines (infectious and parasitic diseases)
A network of academic and industrial collaborations

Know-how “research”

Leader of the chemical synthesis of long chain peptides
Specialist of folding of proteins (toxins, defensins, cytokines, etc.).
Specialist development of synthetic vaccines design (linear antigen, carrier protein coupling, MAP constructions, etc. ..

Know-how “industrial”

GMP certification (2006): peptides for therapeutic use for clinical development and commercial (Certificate number 2006/HMP/FR0069)
Facilities adapted for scale up production: 2500 square meters of space including 300 square meters dedicated GMP (2010)

Ambitious and innovative projects in

Malaria (Institut Pasteur), Cancer (IGR, Institut Curie), auto-immune diseases, transplant rejection, pain, etc. ..