| DEVELOPMENT |

Can Vaccine Development Be Safely Accelerated?

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.
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Delivering the Goods

The new molecules entering the development pipeline are bringing forth exciting challenges in drug delivery.
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Exclusive Interview from AAPS:
Comparative Evaluation of Commonly Employed Plasticizers in Soft Gelatin Capsules
Sponsored by: SPI
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| MANUFACTURING |

Understanding Containment for Tableting

Risk levels should be considered when designing containment for pharmaceutical tableting equipment to enhance operator safety.
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Using Online Transition Analysis to Predict Chromatography Column Failure

Advanced analytics and modeling can be used to predict downstream failures, allowing for corrective action before batches are lost.
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| 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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| 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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| QUALITY/REGULATIONS |

Comparison of Pharmaceutical Excipients and Food Ingredient Requirements

With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.
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| OPERATIONS |

Packaging Preserves the Cold Chain

More sustainable and functional packaging protects temperature-sensitive drugs.
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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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| FROM THE EDITOR |

Pharma’s Leadership Role in a Pandemic

As the coronavirus pandemic unfolds, Pharma must practice science over hype.
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| US REGULATORY WATCH |

Biosimilars Poised for Gains in US Market

FDA is encouraging alternative insulins and challenging anticompetitive practices.
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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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