Quality Control Testing

Employing a team of highly trained experts in the latest International guidelines and company SOPs, SGS has conducted over 800 projects including trials with patients in Western, Eastern and Central Europe, Russia, and North America. SGS’ monitoring and management offices are located in the USA, Fran...

Data management/statistics and medical writing

As one of the largest independent data management teams in Europe, SGS supports all in-house and external project needs for clients’ clinical trials, powered with Clinitrial®, Oracle Clinical® and SAS®. Clients benefit from a knowledgeable, proactiv...

In addition to acceptance tests for the installation of clean rooms in production facilities, SGS can perform routine monitoring of viable and nonviable contamination of production facilities. SGS offers a broad range of monitoring services for clean rooms and can also provide you with customized hygienemo...

The Regulatory Affairs department at SGS offers consulting in both European and U.S. registration of Biotech and, Prescription drugs, veterinary products and medical devices with comprehensive EMEA and FDA authorities expertise. SGS has established strategic submission plans using extensive country specifi...

As a pioneer of physicochemical characterization, we offer you unrivaled expertise in protein analysis. Our laboratories helped to develop mass spectrometry (MS) mapping of biotechnology products, together with other mass spectrometry strategies related to protein/glycoprotein analysis, which have become s...

The assessment of Extractables and Leachables in bio/pharmaceutical products is an important step in drug product development. Processing equipment, as well as, primary and secondary container closures are potential vectors for chemical contaminants. Monomers and polymer additives such as antioxidants, pla...

SGS provides the professional expertise and regulatory qualifications necessary to perform analytical testing of raw materials, APIs, finished products, packaging material and medical devices. Well-equipped state-of-the-art laboratories offer comprehensive testing services according to the pharmacopoei...

SGS’ range of services dedicated to biopharmaceutical product characterization bring the most recent developments in testing technology to companies across the globe. In 2010, SGS acquired the M-Scan Group, the world leaders in the application of advanced mass spectrometry
techniques for protein and c...

SGS is a leader in Microbiology Quality Control testing, providing a complete array of services for the bio/pharmaceutical industry. SGS’ scientists are published and active on the scientific committees of several organizations. Capabilities range from assessment of microbial contamination to confirmat...

SGS life science laboratories have extensive knowledge and expertise in developing and validating methods for raw materials, API’s, finished products and cleaning validation.

SGS offers development and documentation of analytical protocols and reports for proprietary and nonproprietary test met...

In 2012, SGS acquired Vitrology in order to provide a comprehensive range of biosafety services for biologics, including: virology, cell and molecular biology as well as microbiology and electron microscopy. Health Authorities, including the US FDA and the EMA, require biopharmaceuticals to undergo safety ...

From study design to storage, monitoring, analytical testing and documentation, SGS offers services to your complete satisfaction. With more than 25 years of experience and currently more than 100,000 samples in storage, SGS has the skills and the capacity to handle your stability projects. SGS can provide...

The CRO will undertake this clinical trial at multiple sites worldwide, starting at the AZ Sint Maarten hospital in Mechelen, Belgium.

With over 30 years of experience and operating out of our GLP/GCP compliant laboratories. SGS has the expertise to both develop assays from scratch (including LC-MS/MS, immunoassays and cell-based assays) and to support large scale routine sample analyses, from regulatory pre-clinical (toxicology) to early and late clinical studies (Phase I to IV).

A full package of Biologics testing services to cGMP standards from early phase characterisation including Biosafety to Quality Control release testing enabling you to outsource your biologics.

Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging.

Life-saving medicines are heavily regulated during development, manufacture and distribution. To fulfill regulatory requirements, the biopharmaceutical industry is increasingly looking for independent service providers who can deliver comprehensive characterization solutions on one site. SGS’s global center of excellence for cell bank characterization & virus testing is located in the United Kingdom and provides services with ultimate reliability, highest GLP/cGMP quality and scientific expertise.

Mycoplasma are a form of bacteria that are characterized by the absence of a cell wall surrounding the cell membrane. This renders them inert to many familiar antibiotics, including the beta-lactams, whose activity relies on cell wall disruption. Many different mycoplasma are pathogenic in humans, and they are also commonly found as contaminants in cell cultures. Although the contamination does not create turbidity, factors such as cell line growth rates and viral vaccine production can be adversely affected. This clearly poses a problem for processes that involve cell culture, and thus, being able to detect them is important.

Single-use systems (SUS) are increasingly becoming the norm in biologics development and manufacturing. Around 85% of the pre-commercial biopharmaceutical sector uses SUS and it is increasingly being adopted for commercial manufacturing. SUS have significant advantages but are not without drawbacks. A 2018 survey showed that 73.3% of biologics insiders listed contamination from extractables and leachables to be a major problem.

Genetic stability and identity testing are key requirements for regulatory approval of therapeutic biological products produced using a cell bank system.

The potential for economic reward associated with the development of complex generic medicines means there has been dramatic growth in the sector in recent years. However, opportunity is not without complexity. Unlike other medicinal products, manufacturers of complex generics cannot rely on textbook characterization or QC testing to prove compliance with regulations.

Our experts provide effective and efficient testing solutions for analytical development, biologics characterization, biosafety and quality control, as well as clinical research services.