Custom Synthesis
From mg to kg scale – targeted compounds for special needs
We develop your custom chemical synthesis of commercially unavailable reference compounds according to GMP in out independent laboratories.
Suisse TP synthesizes the desired chemical compound on a laboratory scale for its customers.
The pharmaceutical industry benefits from the custom synthesis of commercially unavailable reference compounds, specific impurities (for e.g. accuracy testing in analytical method validation , evaluation of stability indicating properties of analytical methods, reference substances or SST solutions for release testing), exclusive synthesis building blocks or active pharmaceutical ingredients.
Chemical compounds are also synthesized for customers from other industries such as the chemical, cosmetics and food industries.
The characterization of the synthesized substances is carried out using various methods in Suisse TP’s own modern analytical laboratories. At the customer’s request, substance qualifications can also be carried out as an analytical service and certificates of analysis issued.
If you want to learn more about custom synthesis, please continue reading about custom synthesis (or in german about Auftragssynthese) on our company website.
Method development
Appropriate analysis methods need to be developed for new products and for the qualitative and quantitative determination of unknown substances. The experienced analysts of Suisse TP develop optimized and therefore cost-effective analysis methods. If required we develop those methods according to ICH guidline Q2(R2)/Q14 EWG – “Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation”
a few examples of typical applications are
- Development of release-relevant analysis methods for APIs
- Development of analytical methods for the cleaning validation
- Creation of complete analysis packages for the monitoring of chemical production processes
- Development of routine analyses according to customer requirements
- …
We develop your custom chemical synthesis of commercially unavailable reference compounds according to GMP in anindependetlaboratory.
Quality-by-Design (QbD) - development, scale-up and optimization of a chemical synthetic route, leading to a safe, reproducible and economical chemical manufacturing process
Process Analytical Technology (PAT) is a methodology to develop and produce high value chemicals and pharmaceuticals. Critical parameters (CPPs) and key performance indicators (KPIs) of the process are thoroughly understood, well-defined and continually monitored in order to ensure that the pre-defined critical quality attributes (CQA) of the final product are consistently achieved. PAT measures key quality and performance indicators in raw materials, in-process materials and processes in real-time.
