| API SYNTHESIS & MANUFACTURING |

Building Capacity for Potent API Production

Demand for highly potent APIs continues to rise.
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| ASEPTIC MANUFACTURING |

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

Facilities using a matrix of multi-functional cleanrooms can be adapted to efficiently manage the capacity uncertainty of multiproduct commercial manufacturing.
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| SUPPLY CHAIN |

FDA Provides More Clarity on DSCSA

As EU firms strive to meet central and local data-onboarding requirements, FDA extends a time buffer that also increases supply-chain-management complexity.
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| PROCESS MODELLING |

Design Space Characterization and Risk Assessment Through Mechanistic Modelling

Mechanistic process and product modelling turns data into knowledge that can be extrapolated with known confidence.
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| EDITOR'S COMMENT |

Fasten Your Seatbelts …

… Brexit may be a bumpy ride.
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| EUROPEAN REGULATORY WATCH |

Guidelines on Integral Drug-Device Combinations

Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.
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| OUTSOURCING REVIEW |

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 PARAXEL.
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