| LOT RELEASE TESTING |

Unprocessed Bulk Testing for Biopharmaceuticals

Unprocessed bulk material harvested directly from the bioreactor should be tested for contamination prior to downstream processing.
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| LAB OPERATIONS |

NIST Fluorescence-Based Measurement Services

Fluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.
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| PEER-REVIEWED |

Separation and Purification of a Tissue-Type Plasminogen Activator from Trichoderma reesei

This research proposes a method for separating and purifying tissue-type plasminogen activator from a fungal cell source.
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| UPSTREAM PROCESSING |

Achieving Process Balance with Perfusion Bioreactors

Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run.
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|MANUFACTURING |

Overcoming Challenges in ADC Bioconjugation at Commercial Scale

Bioconjugation requires aseptic manufacturing and containment for cytotoxic payloads.
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|OUTSOURCING|

Contract Organizations Expanded in Autumn

CMOs and CDMOs made investments in new and expanded facilities and services in the last quarter of 2018.
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| FROM THE EDITOR |

Bringing Quality into the Forefront

Innovation may capture headlines, but quality programs are the foundation to biopharma success.
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| REGULATORY BEAT |

Quality Manufacturing Key to Reducing Drug Shortages

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.
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| ASK THE EXPERT |

Investigation Timeliness vs. Thoroughness: Finding the Right Balance

A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.
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