Future Supply Chain Trends: The Rise of the Full-service CDMO

Jul 27, 2017

Outsourcing is on the rise, not only among big pharmaceutical firms but also with smaller emerging and even virtual companies, meaning customer requirements are more varied than ever before. As outsourcing continues to gain traction within the pharmaceutical supply chain, companies need to diversify and differentiate their offering to remain competitive. Kevin Cook, CEO of Sterling Pharma Solutions, which develops and manufactures small molecule active pharmaceutical ingredients (APIs), discusses the trends driving the increased demand for contract services partners and the benefits of selecting a full-service CDMO, in place of more niche providers. ...

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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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Temperature Management – Keep Your Cool

Apr 11, 2017

The industry is experiencing an increase in sensitive and sophisticated pharmaceutics, and the compliance with new regulations governing temperature control during processing, storage and transport is on the increase. Any deviation outside the drug stability parameters can have a negative impact on the safety of a patient, which is of significant concern to pharmaceutical companies and regulators alike. In the following editorial, Heather Bogle, Supply Chain Solutions Manager, Almac Group, highlights temperature management in the pharmaceutical supply chain. ...

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