White Papers
Our white papers and technical bulletins are written by industry experts from many different fields, exploring and commentating on a range of complex subjects.
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Customer Service Excellence (CSE) Booklet
The launch of this new standard by the Cabinet Office on heralds the beginning of a new era in Government thinking and the promotion of Customer Service Excellence. |
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Control Viral Contaminants with Effective Testing
In this paper we look at the three principal and complementary approaches for the detection of viral contaminants in biologic-based medicines, and the identification of their origins, with our primary focus on the testing of source materials and products. |
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CDISC Library Try-out: From Implementation to Evaluation of the API
In this paper, we will explain the tool and the API calls in more detail and share our thoughts and findings on the use of CDISC Library within the tool. |
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Understanding Maximum Residue Limits For Pesticides in Food
We examine the best ways to manage pesticide residue risk in food and feed products destined for the EU, US, China and Japan. |
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Biosafety & Safety by Design: Identifying Adventitious Agents in Cell & Gene Therapy Production
In this document we look at cell and gene therapies (CGTs), an important growth sector for the biopharmaceutical industry. |
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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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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. |