Siegfried’s Drug Substance process and chemical development services will assist you in achieving genuinely scalable, cost-effective and robust pharmaceutical manufacturing appropriate to your product’s market needs.
Our talented and innovative development chemists are well experienced either in the development of entirely new synthetic routes or adapting and optimizing an existing process (from Siegfried or our customers). With Siegfried as your drug development partner, you can expect much more refined and commercially viable manufacturing processes.
Siegfried will work closely with you to understand your needs, and will establish the development objectives and scope for process optimization you can expect. Depending on the relevant process status and clinical phase needs, we incorporate many of the following options for you:
|Synthetic route investigation||Determining synthetic route viability|
|Process optimization||Robustness and cost reduction|
|Process implementation, Scale-up||Manufacturing preparation|
|Determining critical process parameters||Validation preparation|
|Salt screening / crystallization program||Interface for product formulation|
|Design of Experiment (DoE) approaches||Exploring process "design spaces"|
|Developing 2nd generation processes||Life cycle management/cost reduction|
Siegfried has development locations in Zofingen (Switzerland), Evionnaz (Switzerland) and Pennsville, (USA), bringing a wealth of experience through more than 1000 transformations in synthetic organic chemistry.
Siegfried efficiently addresses your development goals by employing a close working collaboration between Process & Analytical Development groups and our pilot plant & safety laboratory.
Siegfried labs and production plants are designed to carry out all typical organic chemical reactions and enzyme-catalyzed transformations. Reaction conditions range from -100°C to 300°C and from 1 mbar to 40 bar.
For synthesis, we use batch reactors and continuous flow technology (CFT). Depending on the relevant application, the appropriate equipment is chosen from reaction carousels, double jacketed reactors and even microreactors.
Using synthesis machines, such as LabMax, RC1, parallel synthesis (ChemSpeed ASW 2000P) and Crystal 16 ensures we generate process data and information in the most effective way, speeding up development lead times and gaining greater understanding of reaction parameters.
We conduct synthesis & analysis of high potency materials (with OEL down to 1 µg/m3) in specifically-built, segregated contained laboratory areas.
Siegfried pays special attention to crystallization & product isolation processes, as these are vital for product yield and purity. Manufacturing processes for clearly defined crystal modifications and particle size distribution are developed – aided by various analytical techniques – and complemented by milling processes. Further techniques to manipulate physical form include spray drying, micronization and pre-formulation mixtures.
Finally, our process and chemical development capabilities are fully supported through the regular use of an array of analytical techniques & equipment, including NMR, HPLC, UPLC, GC, LCMS, GCMS, DSC/TGA, and Malvern, Mictrotrac and Helos PSD equipment.