| INTELLECTUAL PROPERTY |

Protecting Biopharm's Intellectual Capital

Safeguarding the know-how behind biopharmaceutical innovation is crucial to the industry's future, but, in the US, some argue it is becoming increasingly difficult to do.
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| UPSTREAM PROCESSING |

Optimizing Late-Stage and Commercial Cell-Culture Processes

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.
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| DOWNSTREAM PROCESSING |

The Challenge of Disruptive Technologies in Bioprocessing

Increasing demand for biologics is driving the need for innovation in bioprocessing.
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| MANUFACTURING |

Industry 4.0 in Biopharmaceutical Manufacturing

Modern technologies, including Industry 4.0 and the Industrial Internet of Things, offer opportunities to increase biopharmaceutical manufacturing efficiency.
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| ANALYTICAL TESTING |

Advances in Analytics for Bioprocessing

Process analytical technology tools have enabled manufacturers to monitor and control their production processes.
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| REGULATIONS |

Biosimilars Raise Manufacturing and Regulatory Challenges

FDA seeks more efficient testing to spur development of less costly biotech therapies.
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| EARLY DEVELOPMENT PIPELINE |

Early Development Obstacles of Biosimilars and Biobetters

Biosimilars and biobetters face developmental challenges to achieving commercialization.
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| FROM THE EDITOR |

Be Quick, But Don't Hurry

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.
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| ASK THE EXPERT |

Seeking Regulatory Advice

Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
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