Peptisyntha is a leading cGMP manufacturer of therapeutic peptides (peptide APIs) and peptidomimetics serving customers of the pharmaceutical, biotech, diagnostic and cosmetic industries.
From process development for a few milligrams to the manufacturing of several hundred kilograms of peptides, Peptisyntha has strong track records in providing scale-up under full cGMP conditions. The company which was founded in 1987 is proud of having successfully developed processes to supply several 100's of kilograms of challenging peptide sequences. With more than 23 years of experience in peptide manufacturing, Peptisyntha provides a seamless portfolio of expertise from lead optimization to commercial cGMP manufacturing.
SPPS, LPPS or hybrid? The best manufacturing approach for your project
Peptisyntha possesses state-of-the-art equipments to efficiently cover the manufacture of diverse volumes of peptide APIs by:
- Solid phase peptide synthesis (SPPS)
- Liquid Phase Peptide Synthesis (LPPS)
- Hybrid Strategies (SPPS-LPPS)
Our team of experts will design the most efficient process for your API. Innovative LPPS technologies such as persilyation, handling of arginine-rich peptides, synthesis of short peptides without HPLC purification, peptides with multiple disulfide bridges or conjugations allow cost effective processes by reducing the number of chemical steps and increasing yields.
For SPPS Peptisyntha has, for instance, extensive experience both in Fmoc and Boc strategies and has successfully produced peptides with more than 100 residues. Last but not least, Peptisyntha offers hybrid strategies by designing best fragment strategies by coupling either in solution or on solid support to achieve the highest crude purity and avoiding extensive HPLC purification.
Excellence in cost effective processes
Our performance is a result of sound expertise in process chemistry and analytics combined with innovative solutions and custom services. This yields to short delivery times and excellence in cost effective processes. In addition to that, a range of patented technologies guarantee that your project benefits from our competitive advantage.
FDA and EMEA inspected facilities
The Peptisyntha teams in Brussels (Belgium) and Torrance (California, USA) are following a strong and long-term commitment to the highest standards. These ambitions are reflected by regular and successful FDA (no form 483) and EMEA inspections of our state of the art facilities.
Quality and regulatory expertise
Furthermore, by providing outstanding quality assurance and regulatory support, Peptisyntha underlines its dedication for its customers. Your product deserves the best regulatory support possible. During every single step in your product development, Peptisyntha will have a team of regulatory and quality experts at your disposal to support you.
The set of our capabilities enable us to meet your project needs and to serve you with innovation, performance and dedication – for 'Your Chemistry for Life.'
In brief, Peptisyntha serves you with:
- Therapeutic peptides (peptide APIs) and peptidomimetics
- More than 23 years of peptide manufacturing experience
- Expertise from lead optimisation to commercial cGMP
- SPPS, LPPS and HYBRID Peptide Synthesis
- Excellence in Cost Effective Processes
- FDA (no form 483) and EMEA Inspected Facilities in Europe and USA
- Quality assurance and regulatory support (Development, qualification and validation of the analytical test methods, stability studies, reference standard qualification and regulatory support: CMC support, filing, support with the regulatory agencies)