| BIOMANUFACTURING |

Reinventing the Biomanufacturing Wheel

To achieve further cost reductions in biosimilar manufacturing, a move away from traditional models is necessary.
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| DOWNSTREAM PROCESSING |

What's New in Downstream Processing

The latest advances in downstream processing include remote monitoring, membrane chromatography technology, single-use sensors, and new uses of data analytics.
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| MANUFACTURING |

Cleaning Chromatography Resin Residues from Surfaces

Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.
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| MANUFACTURING: LYOPHILIZATION |

Changing Perceptions: An Understanding of Lyophilization Advancements

Technical advances in process understanding and control must be accompanied by a change in mindset.
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| ANALYTICS |

Leveraging Computational Models of Glycosylation for Biopharma QA

Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
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| INTERNATIONAL REGULATIONS |

Going Global in Biopharma Regulatory Affairs

Globally accepted products are becoming increasingly in demand, leading to more need for regulatory harmonization, particularly for biosimilars.
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| OUTSOURCING |

Where Automation Meets Skill Set

A look at the skill sets and training needed to tackle the increasing levels of automation in bioprocessing facilities.
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| INTELLECTUAL PROPERTY |

Predictability Improves Prospects for Biopharma Patent Holders

While it may not be getting easier, biopharma patent protection is at least becoming more predictable.
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| FROM THE EDITOR |

Keeping the Patient and Public Health in Focus

Promoting patient compliance with drug regimens extends beyond the formulation laboratory.
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| REGULATORY BEAT |

Continuous Manufacturing Gains Major Push from FDA

FDA is moving to shift industry away from step-wise batch production.
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| ASK THE EXPERT |

Channeling Customer Complaints into Quality

A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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