Peptisyntha - Custom Process Development and Contract Manufacturing of Peptides

The activities of Peptisyntha focus on the production of large volumes of therapeutic peptides (peptide APIs) and are supported by decades of experience in solution phase and solid phase technologies. Peptisyntha is able to scale up the production of peptides from a lab scale process development study up to the c-GMP production of hundreds of kilograms.

The availability of both liquid phase and solid phase technologies enables Peptisyntha to be an efficient, dependable and flexible partner whenever it comes to outsourcing the manufacture of therapeutic peptides at all stages from preclinical to commercial requirements.

PEPTIDE PROCESS DEVELOPMENT

For any peptide sequence, the choice between different methods of synthesis is not only dictated by the detailed peptide sequence itself, but also by characteristics of the whole project (purity required, quantities required at different stages, development timelines…). With our versatile peptide chemistries including Solution Phase and Solid Phase Peptide Synthesis, a wide range of possibilities can be screened at the early phase of the project.

At Peptisyntha, process development for a given peptide may be handled by SPPS or by solution phase chemistry, or may require both technologies (so-called hybrid production methods). After the first quantities have been synthesized in the laboratory, scale-up can be undertaken under cGMP conditions in our kilolabs by SPPS or by solution phase synthesis. Successive scale-up can be considered, depending on the customers' requirements during clinical development. Eventually, large-scale cGMP production (up to 100+ kg per year) can be made in a dedicated commercial production suite.

At each and every stage, we provide complete documentation and support in accordance with the requirements of the customer's project status.

EXPERTISE IN BULK PEPTIDE PRODUCTION

The technology used by Peptisyntha can be applied to scale up the production of peptides from a lab scale process development study up to the production of hundreds of kilograms, in strict compliance with the current GMP regulations. The recognized expertise in peptide synthesis is complemented by a comprehensive know-how in purification techniques, especially preparative HPLC. The latter is available at all scales, from the process development laboratories up to the large-scale commercial production units. Similarly, a full range of lyophilization equipment is available.

As far as liquid phase synthesis is concerned, Peptisyntha applies a specific technology, which consists in the use of persilylated amino acids and intermediates. This technology, combined with more traditional liquid phase peptide chemistry, allows a significant reduction of the number of steps and leads to the cost effective production of large quantities of peptides.

The QA department is involved right from the start in any project, which guarantees cGMP production, testing and documentation standards in accordance with the most stringent FDA and EMEA requirements. At all stages from the laboratory bench, through the scale-up studies in kilolabs, and up to the large scale commercial production, we offer a full range of services, including: process development, c-GMP production of gram to multikilogram batches, development and validation of analytical methods, stability studies, scale-up studies in kilolabs and pilot plant, process validation, regulatory support including DMF compilation and filing.

PEPTISYNTHA LOCATIONS

Peptisyntha operates in two locations with Peptisyntha SA in Brussels, Belgium and Peptisyntha Inc. in Torrance, California. The state-of-the art facilities for the large scale production of peptides have been successfully inspected by the FDA.

SOLVAY GROUP

Peptisyntha is a wholly owned subsidiary of Solvay, an international chemical and pharmaceutical company headquartered in Brussels, Belgium. As a fully autonomous business entity, Peptisyntha is a flexible and reactive partner, while its affiliation with Solvay guarantees the access to financial resources to support our investment programs.