Environmental Monitoring and Reporting Facilitated by LIMS

Jul 27, 2017

Environmental monitoring (EM) is an essential part of any pharmaceutical, medical device or biotechnology manufacturing process. It ensures that microbiological and particulate levels in the controlled manufacturing environment are maintained within acceptable limits. The EM programme will involve a regular regime of testing based on location and frequency. The results are used to monitor trends and trigger the appropriate corrective action if a limit is exceeded. Simon Wood PhD, Product Manager at Autoscribe, submits a feature on laboratory information management systems. ...

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The Advantages of LC/MS in Identifying Residual Impurities in Biopharmaceuticals

Jul 27, 2017

Fergus Hall, PhD, Section Manager, Pharmaceutical Chemistry at Eurofins BioPharma Product Testing, looks at the complexity of detecting and quantifying residual impurities which are usually present at low concentrations within difficult sample matrices. He will discuss the broad selection of detection methodologies currently available, specifically focusing on the advantages of high-performance liquid chromatography mass spectrometry (HPLC/MS) for process validation studies. ...

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Working with Difficult Preparations – Risks, Regulations, and Considerations

Jul 27, 2017

Safety testing is a crucial part of drug development and is dictated by pharmacopoeial guidelines, which must be followed when performing each step of the process. Ideally, the method development stage is when any potential sample preparation problems are resolved to make the routine analysis easier; however, depending on the product in question, this can become a lengthy process as preparation methods can vary broadly. John McKenzie PhD, FRSC Chief Executive Officer at Wickham Laboratories Ltd looks at risks, regulations, and considerations. ...

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Propelling Holistic Risk Management Using a Next-generation RBM Approach

Jul 27, 2017

As the nature of clinical trials grows ever more complex, the requirement for an improved risk-based monitoring (RBM) approach increases. Such an approach improves the quality of clinical studies and facilitates better adherence to new guidelines from regulatory agencies. When implemented effectively, RBM reduces site monitoring costs, enhances oversight and provides a near real-time overview of data. It can enable life science companies to prioritise resources around identifiable risks relating to the safety of participants, and the quality and integrity of clinical trial data. In this technical editorial, Sudeep Pattnaik, President & CEO of ThoughtSphere, analyses holistic risk management. ...

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Will Graph Database Technology Uncover Pharma’s Hidden Insights?

Jul 27, 2017

By definition, medical research is about dealing with large quantities of data. That’s even truer in the leading edges of the life sciences, where tackling the thorny issues in genomics and personalised treatments has to take place at the petabyte and increasingly the exabyte, rather the mere megabyte and gigabyte level in terms of promising dataset size. Neo Technology’s Emil Eifrem looks at how life science researchers can probe large datasets efficiently and expose new insights with the unique power of graph technology. ...

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