Siegfried recognizes and understands the importance of requisite analytical parameters & controls, as they are vital for ensuring effective and robust processes.
Our well-experienced Drug Substance Analytical Development team works closely with their Process Development counterparts to ensure our customer’s product is fully supported at every phase of the development process. Modernly equipped, we provide the following range of analytical services to help bring your drug substance development project & cGMP manufacture to fruition:
Siegfried works closely with you to understand your needs and establish the analytical objectives and development scope you can expect. Our shared goal is to develop routine procedures and efficient analytical testing methods packaged together with specifications suitable for Quality Control.
Depending on the relevant process status and a project’s clinical phase needs we incorporate many of the following development options:
|Method development||Product quality and process control procedure|
|Method optimization||Robustness and cost reduction|
|Method transfer||Production preparation according to the cGMP-guidelines|
|Method validation||Production preparation according to the cGMP-guidelines|
|Stability studies support||Durability regulations according to the ICH guidelines|
|Optimization of the routine method||Life cycle management and cost reduction|
Siegfried has analytical development locations in Zofingen (Switzerland), Evionnaz (Switzerland) and Pennsville, (USA), bringing a wealth of experience with more than 500 method validations in accordance with ICH Guidelines.
Having vast experience in cGMP compliance, we are able to support and advise our customers on relevant analytical aspects in the pharmaceutical sector (purity profiles, impurity tracking, establishing limits, structure determination, genotoxic contamination, heavy metal determinations, etc.).
For projects involving both Drug Substance and Drug Product, we similarly operate in close cooperation with Drug Product Analytical Development for characterization of the active ingredient and generation of specifications.
Modern analytical instruments available:
→ HPLC, UPLC, GC (controlled via a CDS central server)
→ LC-MS, GC-MS, ICP-MS, NMR, IC, DSC, particle sizes, AAS, UV, IR, NIR, Raman and wet-chemical standard methods for the release of raw materials, intermediate products and APIs.
The analytical data, standards, specifications and testing guidelines are managed using a validated LIMS system.
With Siegfried’s approach to project management, you can expect your own dedicated analytical project manager who coordinates the project’s internal analytical aspects with your analytical department and external service partners.
Once method development is complete, Quality Control puts a well-defined process in place to ensure smooth method transfers for routine operation.