Biologics Charaterization

CMC CONSULTANCY PRE-CLINICAL FORMULATION SCREENING FORMULATION DEVELOPMENT ANALYTICAL SERVICES GMP CLINICAL MANUFACTURING COMMERCIAL & SPECIALS MANUFACTURING CLINICAL TRIAL SUPPLY

SGS Life Sciences has considerable expertise in the method development of nitrosamine determination in pharmaceutical products. SGS has established a specific method for NDMA which can be applied to various different matrices. Alternatively, a platform method, based on trace-level detection by LC-MSMS, is ...

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. Regulatory bodies such as the US Food and Drug Administration (FDA) and T...

Bringing a compound from the laboratory to the market is a long and winding road with a great number of scientific, safety and regulatory challenges. SGS has been offering high quality analytical testing and clinical research services to support drug research, registration and production. 
SGS leve...

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 glo...

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 & scientific expertise.

For any of your biologics, we help you comply with the global regula...

Impurities and contaminants analysis in biotechnology products from SGS – a range of services providing impurities and contaminants characterization in biotechnology derived products and microbial contamination control.To help you meet ICH Q6B guidelines, you need accurate impurities and contaminants analy...

At SGS, we are leaders in microbiology testing services for quality control, providing a complete array of services for the bio/pharmaceutical industry.The microbiological attributes of pharmaceutical ingredients are often critical to final product quality. 
FDA expects manufacturers to measure and...

Delivering a product from discovery to the market is a long and often difficult process filled with a great number of scientific, safety and regulatory challenges. From early discovery to final product release, SGS offers a broad portfolio of high quality, analytical chemistry services using advanced metho...

From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.
When it comes to testing the stability of your pharmaceutical and biologic projects, you need world-class expertise and resources. With over 2...

 SGS realizes that the package or container that carries your product is vital to its safety and efficacy: a weak container, or one that allows contamination of your product, could put the health of your customers and your reputation at risk. SGS package and container testing services offer a ran...

As a world leader in biopharmaceutical testing services, we offer you a comprehensive range of biologics safety testing , including virology, cell and molecular biology, as well as microbiology and electron microscopy. As a result, we can help you to ensure product safety and meet your regulatory requireme...

In a consortium led by the Jenner Institute, Oxford University, SGS has joined forces with specialists in infectious diseases, research and innovation, and pharmaceuticals to rapidly develop, scale-up and produce a potential vaccine called ChAdOx1 nCov-19

Bringing a compound from the laboratory to the market is a long and winding road with a great number of scientific, safety and regulatory challenges. SGS has been offering high quality analytical testing and clinical research services to support drug research, registration and production. 
SGS leverages its conveniently located network of laboratories and clinical trial facilities present in North America, Europe and Asia-Pacific, to deliver harmonized solutions to large pharmaceutical and biotechnology firms. 
Our experts provide effective and efficient testing solutions for analytical development, biologics characterization, biosafety and quality control, as well as clinical research services. We perform a variety of tests that are bespoke, client-specific and support the full clinical development, from Phase I First-in-Human trials in our Clinical Pharmacology Units to Phase II and Phase III studies in patients.