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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Retailers: Understanding the Risks of Global Supply Chains
We present an investigation into supply chain complexity, considering how to reduce risk for retailers. |
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A Consideration of H1N1/09pdm and New Variant H3N2/13 as Agents for Human Challenge Trials
Within the field of influenza research, there is becoming an increasingly large place for Human or Viral Challenge Trials (HCT). |
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Sputum Induction Method to Optimize Respiratory Patient Clinical Trials
This white paper will examine the use of sputum induction as a pharmacodynamic method to optimize respiratory patient clinical trials, including comparison to other methods, and a case study looking at asthma patients and healthy volunteers. |
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Early Phase Clinical Trials in Patients with Hepatic or Renal Impairment
FDA and EMA guidances are intended to help companies evaluate the need for conducting PK studies in renal and hepatic impaired patients. Although many procedural recommendations exist, some key questions still need to be investigated case-by-case at the early stage of the project development. |
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Transparency-One: Supply Chain Visibility
We discuss the profound transformation taking place in food shopping and shopper behavior, and the challenges in monitoring the supply chain and measuring product compliance to drive consumer trust. |
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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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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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Keeping Metallic and Non Metallic Surfaces Free of Oil and Grease
Various branches of industry are placing increasing value on the cleanliness of manufacturing components. Learn more about how SGS developed an appropriate preparation processes for investigations to determine the amount of oil and grease present on metallic and non-metallic surfaces. |
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Öl- und Fettfreiheit auf metallischen und nichtmetallischen Oberflächen
Verschiedene Industriezweige legen immer größeren Wert auf die Sauberkeit von Bauteilen. Lesen Sie wie die SGS Präparationsverfahren für die Untersuchungen zum Öl- und Fettgehalt auf metallischen und nichtmetallischen Oberflächen weiterentwickelt. |
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Primary and Higher-Order Structural Characterization Strategy for Biosimilarity Assessment
This article addresses some issues involved in meeting regulatory characterization expectations for biosimilars. |