EXTRACTABLES AND LEACHABLES: DETERMINING RISK IN SINGLE-USE SYSTEMS FOR THE BIOLOGICS INDUSTRY

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.

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.