White Papers
Our white papers are written by technical experts from many different fields, exploring and commentating on a range of complex subjects.
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Cell Substrate Characterization: Genetic Stability & Identity Testing at SGS
Learn about genetic stability and identity testing, key requirements for regulatory approval of therapeutic biological products produced using a cell bank system. |
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Transmission Electron Microscopy: Applications in Biosafety Testing
This white paper looks at the role Transmission Electron Microscopy (TEM) plays in biological sciences and in the assessment of biological safety, particularly in virology. |
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Cell Substrate Characterization In-Vitro Based Detection Methods
Regulatory authorities such as the US Food & Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) impose stringent limits on the amount of microbial contaminants and impurities present during the manufacturing of biological medicines and vaccines. |
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Nucleic Acid Amplification Techniques (NAT) to Address Biosafety of Biological Therapies
Over the past 15 years, nucleic acid amplification techniques (NAT), also referred to as polymerase chain reaction (PCR), have played an increasingly important role in the characterization and evaluation of biosafety for human biological therapies. |
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California Cleaning Products: Right to Know Act
The California Cleaning Product Right to Know Act of 2017 is the first legislation in the United States requiring cleaning products to publicly disclose a defined and regulated list of ingredients. This white paper provides an introduction to the Act and details the products covered and the requirements for disclosure. |
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Detection of Mycoplasma in Biopharmaceuticals, Vaccines, and Gene Cell Therapies
The detection of mycoplasma contamination is of utmost concern in bio-therapeutic and vaccine manufacturing. Now that streamlined assay validation procedures and GMP validated NAT tests are readily available, these methods can provide manufacturers with confidence in results required in production and batch release of products. |
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Developing Effective Risk Mitigation Practices in Response to California Proposition 65
Businesses operating in California, USA, need to understand Proposition 65 (Prop 65). In this white paper we explain Prop 65 and consider effective risk mitigation practices. |
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Identification of Surface Impurities and Particles by Means of Special Analysis Methods
This paper describes some special analytical techniques, their advantages and disadvantages and their application for particle material identification as well as for surface contamination characterization. |
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European Union ROHS2 - Understanding Requirements and Compliance Strategies
The EU’s RoHS2 Directive restricts the use of certain hazardous substances in electrical and electronic equipment. In this white paper we consider the terms of this regulation and the ways stakeholders can ensure compliance. |
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Global Access Program (GAP) for Electrical & Electronics (E&E) Products
This white paper cautions how, without demonstrating compliance and achieving certification against the relevant national and international standards, manufacturers and importers will struggle to reach new markets. |