Analytical Development
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 work 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 intimately with you to understand your needs and establish the analytical objectives and development scope you 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 clinical phase needs, we incorporate many of the following options:
Option
Method development
Method optimization
Method transfer
Method validation
Support stability studies
Optimization of routine methods
Focus
Establish product quality & process control relevant procedures
Robustness and cost reduction
Preparation for cGMP manufacture
Preparation for cGMP manufacture
Determining shelf-life in accordance with ICH Guidelines
Life cycle management and cost reduction
Siegfried has analytical development locations both in Zofingen (Switzerland) and Pennsville, NJ (USA). These two facilities offer a wealth of experience from more than 500 method validations developed in accordance with ICH Guidelines.
With our vast experience in cGMP compliance, we can support and advise you in all the analytical aspects of the pharmaceutical sector (purity profiles, impurity tracking, establishing limits, structure determination, genotoxic contamination, heavy metal determinations, etc.).
Development Team
Our teams from Process & Chemical Development work closely with Siegfried’s pilot plants and Quality Control specialists to ensure your analytical development goals are met.
Similarly, for projects involving both Drug Substance and Drug Product, we operate in close cooperation with Drug Product Analytical Development to characterize the active ingredient and generate its specifications.
Technology
We use the latest technology in analytical instrumentation including:
- HPLC, UPLC, GC (controlled via a CDS central server)
- LC-MS, GC-MS, NMR, IC, DSC, particle sizes, AAS, UV, IR 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.
Analytical Project Management
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.