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Our white papers are written by technical experts from many different fields, exploring and commentating on a range of complex subjects.

CSE 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 white paper thumbnail 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 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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Global MRLs for Food Pesticides White Paper 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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Identifying Adventitious Agents in Cell & Gene Therapy Production 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 Characterisation: Genetic Stability and Identity Testing at SGS (Glasgow) 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 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 Subtrate 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 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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Right to know Act White paper thumbnail 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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