This will significantly boost the company's capacity to serve as a "one-stop shop" with fast, high-quality and cost-effective QC, complementing Solvias' established reputation in cutting-edge R&D.
With the full integration of the QC-release team from the Swiss-based Confarma AG (part of the acquisition of Confarma in 2013), Solvias has significantly expanded its physical-chemical Quality Control capabilities for both small molecules and biopharmaceuticals.
Combining cutting-edge research and development in analytics and an expanded QC capacity under one roof makes it easier for customers to consolidate outsourcing activities and simplifies the process of preparing for regulatory audits. And if unexpected issues surface during the QC process - for example, leaching from packaging materials - Solvias' R&D expertise is immediately available to solve the problem.
The QC department will concentrate on the analysis of Phase III and commercial products, including release and stability testing. The new dedicated QC department in Kaiseraugst offers a wide range of QC technologies, covering 95% of compendial methods (Ph. Eur., USP and JP), including the following:
- Chromatographic technics, including UHPLC, spectroscopic methods as well as classical wet chemistry
- Galenical tests for all dosage forms
- Aerodynamic particle sizing (e.g. NGI for inhalers)
- Enzyme activities
With the new QC department, Solvias is ideally positioned to support its clients' increasingly stringent quality and safety standards and the expanding demands of regulatory authorities. And since every customer's QC needs are different, Solvias staff-members are trained to be flexible and work with each client to find the most efficient solutions. In addition to physical-chemical testing at its headquarters in Kaiseraugst, Solvias maintains a hub for microbiological QC at its French affiliate Confarma in Hombourg.