| UPSTREAM PROCESSING |

N-Glycan Analysis of Biotherapeutic Proteins

This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
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| RESIDUAL IMPURITIES |

Managing Residual Impurities During Downstream Processing

Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
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| MANUFACTURING |

Particle Analysis Techniques Help Meet Regulatory Requirements

An increase in biologics raises awareness of particle generation and its role in negative patient outcomes.
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| ANALYTICS |

A Novel Metric for Continuous Improvement During Stage Three

How statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.
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| SUPPLY CHAIN |

Storing and Shipping Frozen APIs in Single-Use Containers

As more companies decouple drug substance from finished drug manufacturing operations, an integrated approach can ensure safe, reliable logistics for frozen storage and shipping.
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| GUEST EDITORIAL |

Drug Spending Not Driving Rising Healthcare Costs

New reports indicate that drug prices are slowing compared to other healthcare costs.
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| US REGULATORY BEAT |

Efficient Manufacturing Critical for Accelerated Drug Development

Approval of breakthrough therapies requires expedited quality assessment.
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| PERSPECTIVES ON OUTSOURCING |

Update on Continuous Bioprocessing: From the Industry's Perception to Reality

Although widespread adoption of continuous bioprocessing has been slow, some processes have been an exception.
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| TROUBLESHOOTING |

Troubleshooting Lab Operations: Be Proactive, Not Reactive

This article reviews systems and processes that enable a laboratory to approach troubleshooting in an effective way, while also taking a proactive, preventive approach to managing atypical laboratory scenarios.
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