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

Step 2 Preclinical studies

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

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 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 5 Clinical trial phase 3

Process validation.
Stability studies.
Update of CMC.

Go to market

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

About Us

Synprosis was founded in 2003 to develop and produce a synthetic vaccine designed to fight against one of the three major contemporary pandemics: HIV (TAT Oyi vaccine project )

To achieve this scientific goal, the company developed unique expertise in the industrial synthesis of long peptides (or long-chains), leading to the production of entirely synthetic vaccines.

This competitive advantage materialized in 2006 with the GMP (Good Manufacturing Practices) certification, allowing Synprosis to be identified by the market as a leading global provider of long peptides used in human therapy.

The company has developed a dual model revolving around internal R&D (candidate vaccines against infectious or parasitic diseases based on synthetic peptides) and around a GMP activity on behalf of public or private partners, mainly focusing on synthetic vaccine projects.

Thanks to this latter activity, Synprosis is now positioned on the 3-5 year horizon as both a major supplier of the future API (Active Pharmaceutical Ingredient) drug development market and a major vaccine designer.

About Us

API Development Phases

Fuveau Plant

About Us