Biologics Characterization
Product Description
SGS North America Inc.
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US -
2015On CPHI since
Categories
SGS North America Inc.
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US
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2015On CPHI since
More Products from SGS North America Inc. (15)
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Product Environmental Monitoring
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... -
Product Regulatory & Medical Affairs
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... -
Product Biologics Characterization Services
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... -
Product Extractables & Leachables Testing
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... -
Product Quality Control Testing
Analytical chemistry services from SGS provide you with the bio/pharmaceutical expertise and regulatory qualifications to perform the necessary raw material testing, and testing on APIs, finished products, packaging material and medical devices. -
Product Analytical Chemistry
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... -
Product Microbiological Testing
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... -
Product Method Development & Validation
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... -
Product Biosafety Testing
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 ... -
Product Stability Studies
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... -
Product Bioanalytical Testing
As a leading bioanalytical service provider, with GLP/GMP compliant laboratories, we are able to serve pharmaceutical and biopharmaceutical companies of all sizes with a range of tests for drug development at both pre- clinical and clinical stages – from early to late phase. We also develop assays (includi... -
Product Package and Container Testing
SGS is an industry leader in Package and Container Testing (USP, EP, JP, BP), providing full packaging testing for the drug industry. The safety and efficacy of any pharmaceutical product is inextricably linked to its packaging. Containers or closures that do not meet the physical, chemical, or biologi...
SGS North America Inc. resources (10)
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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).
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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.
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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.
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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.
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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.
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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.
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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.
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Whitepaper 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.
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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.
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