Process and Chemical Development
Siegfried’s Drug Substance process and chemical development services help you achieve genuinely scalable, cost-effective and robust pharmaceutical manufacturing that are tailored for your product’s market needs. Our talented and innovative development chemists are well experienced in adapting and optimizing an existing process (from Siegfried or our customers) as well as developing entirely new synthetic routes. You can expect much more refined and commercially viable manufacturing processes with Siegfried as your drug development partner.
Siegfried works closely with you to understand your needs. We define and implement the development objectives and scope for process optimization that you expect. Depending on the relevant process status and clinical phase needs, we can incorporate many of the following options for you:
Option
Synthetic route investigation
Process optimization
Process implementation
Determining critical process parameters
Salt screening / crystallization program
Design of Experiment (DoE) approaches
Developing 2nd generation processes
Focus
Determining synthetic route viability
Robustness and cost reduction
Manufacturing preparation
Validation preparation
Interface for product formulation
Exploring process "design spaces"
Life cycle management/cost reduction
Siegfried has development locations in both Zofingen (Switzerland) and Pennsville, NJ (USA), with a wealth of experience built on more than 1000 transformations in synthetic organic chemistry.
We achieve your development goals by employing a close and efficient collaboration between Process & Analytical Development groups, and our Pilot plant & safety laboratory.
Technology
Siegfried labs and production plants are designed to carry out all typical organic chemical reactions, and enzyme-catalyzed transformations. Reaction conditions range from -80°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 in some cases, microreactors.
Using synthesis machines, such as LabMax, RC1, parallel synthesis (ChemSpeed ASW 2000P) and Crystal 16, ensures that we generate process data and information effectively, which not only speeds up development lead times, but allows for a greater understanding of reaction parameters.
We conduct synthesis and analysis of high potency materials (with OEL down to 1 μg/m³) in specifically-built, segregated contained laboratory areas.
We pay 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 are 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 and Helos PSD equipment.