Go to market

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

Key dates

2003

Creation of Synprosis sarl

2004-2005

Laureate of contest of French ministry of research (“création développement”)
First facilities for peptide synthesis in Marseille

2006

cGMP certification (AFSsAPS) for therapeutic peptide synthesis

2007-2009

In vaccine field Synprosis puts its expertise at the service of candidate vaccines to its customers. Synprosis conducts all stages of synthetic antigen design (linear peptides, conjugated peptides or MAPS) for various customers and partners, and provides GMP production of vaccine candidates (APIs and drug products).

As example : MSP3 malaria vaccine candidate of Institut Pasteur France (http://www.pasteur.fr/ip/easysite/go/03b-000016-022/press-releases/2007/malaria-the-importance-of-the-msp3-candidate-vaccine-has-been-confirmed), Curavac Vaccine candidate in Myasthenie Gravis (http://www.curavac.com/About.aspx ), etc

2010

Since july 2010 Synprosis expands new facilities of 2500 sqm, at Fuveau close to Aix en Provence (13100 France) dedicated for large scale GMP peptides synthesis and vaccine development.

About Us

API Development Phases

Fuveau Plant