| PEER-REVIEWED RESEARCH |

Optimizing Manufacturing Based on the Storage Stability of Pegylated Products

Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
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| MANUFACTURING |

Best Practices in Handling HPAPIs

Establishing OEL data and ensuring appropriate engineering controls are crucial aspects of safe handling.
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New Technologies for Fill/Finish Streamline Operations

Advances in fill/finish for parenteral packaging address demands for efficiency and product safety.
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| QUALITY/REGULATIONS |

Using Software in Process Validation

Software systems can help validate pharmaceutical manufacturing.
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Lessons from FDA 483s and cGMP Inspection Data

Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.
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Getting in Touch with New Guidance on Topical Products

Changing regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.
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| ANALYTICS |

The Fundamentals of Dissolution Testing

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.
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Distribution of Data: The Central Limit Theorem

Using the central limit theorem concerning the distribution of means allows one to justify the assumption of the normal distribution.
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| SUPPLY CHAIN |

Tracking Raw Materials in Biopharma Manufacturing

Automated, electronic systems for raw materials tracking improve efficiency and prevent mistakes in biopharma manufacturing.
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| OUTSOURCING |

Best Practices for Studying Stability in Biologics

Industry experts discuss the challenges and regulations of setting up a CGMP-compliant stability testing programme.
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| EDITOR'S COMMENT |

The Never-Ending Brexit?

With no plausibly approvable deal on the table in the UK government at the moment, it is possible that Brexit could be extended even further.
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| EUROPEAN REGULATORY WATCH |

Out with the Old and In with the New European Commission

A new European Commission is likely, with the support of a new European Parliament, to give a higher profile to healthcare and pharmaceutical matters during its five years in office.
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