| API SYNTHESIS & MANUFACTURING |

Building Capacity for Potent API Production

Demand for highly potent APIs continues to rise.
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| PEER-REVIEWED RESEARCH |

Uniformity of Dosage Units, Part 1: Acceptance Value

This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.
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| MEDIA AND SUPPLEMENTS |

Media Requirements for Different Cell Sources

This article will explore the requirements for media and supplements needed to maintain newer cell lines, such as those based on human cells and fungal cells.
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| MANUFACTURING |

Multi-Purpose Biopharmaceutical Manufacturing Facilities Part II: Large-Scale Production

A matrix of multi-functional cleanrooms can be adapted for launching products.
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| PROCESS MODELING |

Design Space Characterization and Risk Assessment Through Mechanistic Modeling

Mechanistic process and product modeling turns data into knowledge that can be extrapolated with known confidence for design space characterization and risk assessment.
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| SUPPLY CHAIN: TRACK AND TRACE |

FDA Provides More Clarity on DSCSA

New FDA guidance offers a time buffer but increases supply-chain-management complexity, as active DSCSA enforcement begins.
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| FROM THE EDITOR |

Innovation and Industry Strength Recognized at CPhI

Survey results and record attendance show positive signs for various bio/pharma regions.
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| US REGULATORY WATCH |

FDA Promotes Complex Generics and Combination Products

To achieve a more dynamic marketplace, FDA is issuing guidance documents and targeted advisories to support R&D on complex generics and combination products.
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| OUTSOURCING OUTLOOK |

Single-Use Bioprocessing Equipment Trends and Adoption by CMOs

The growth in adoption of single-use systems for commercial manufacturing will be dramatic in coming years.
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| ASK THE EXPERT |

User Requirements Specifications–How Difficult Can It Be?

Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.
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