| PEER-REVIEWED RESEARCH |

Identifying the Structure of an Unknown Impurity in a Topical Gel

This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.
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| MANUFACTURING |

Understanding Containment for Tabletting

Risk levels should be considered when designing containment for pharmaceutical tabletting equipment to enhance operator safety.
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| OPERATIONS |

Packaging Preserves the Cold Chain

More sustainable and functional packaging protects temperature-sensitive drugs.
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| SUPPLY CHAIN |

Being Vigilant in Supplier Oversight

Risk assessments, audits, and good communication between sponsor and supplier are key elements of supplier oversight.
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| OUTSOURCING |

Biomanufacturing: Demand for Continuous Bioprocessing Increasing

But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options.
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| ANALYTICS |

Alternative Cleaning Validation Methods for Biologics

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.
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| EDITOR'S COMMENT |

Making Every Effort

As COVID-19 rapidly spreads, the bio/pharma industry is committing significant efforts to fast track development of therapies.
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| EUROPEAN REGULATORY WATCH |

Learning Lessons in Crisis Management

Regulatory emergency planning has been put to the test with the COVID-19 pandemic.
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| ASK THE EXPERT |

Critical Knowledge for Preparing Audits

Addressing data integrity, quality culture, aging facilities, investigations/corrective actions and preventive actions, and risk management is key when conducting audits, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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