COMPLEX GENERIC APIS: A PRIMER
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.
SGS North America Inc.
-
US
-
2015On CPHI since
Other Content from SGS North America Inc. (9)
-
News SGS joins with Biophytis to launch international trial of COVID-19 related respiratory failure treatment
The CRO will undertake this clinical trial at multiple sites worldwide, starting at the AZ Sint Maarten hospital in Mechelen, Belgium. -
Brochure Bioanalysis Testing Solutions
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).
-
Brochure Biologics Testing Services
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.
-
Brochure Extractables & Leachables Testing Services
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.
-
Brochure Biosafety Testing Services
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.
-
Whitepaper DETECTION OF MYCOPLASMA IN BIOPHARMACEUTICALS VACCINES AND GENE CELL THERAPIES
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.
-
Whitepaper EXTRACTABLES AND LEACHABLES: DETERMINING RISK IN SINGLE-USE SYSTEMS FOR THE BIOLOGICS INDUSTRY
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.
-
Whitepaper Cell substrate Characterization - Genetic Stability and Identity Testing at SGS
Genetic stability and identity testing are key requirements for regulatory approval of therapeutic biological products produced using a cell bank system.
-
Brochure SGS Life Sciences Drug Development Services
Our experts provide effective and efficient testing solutions for analytical development, biologics characterization, biosafety and quality control, as well as clinical research services.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance