| EXPRESSION SYSTEMS |

The Search for Next-Gen Expression Systems

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.
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| ASEPTIC MANUFACTURING |

Aseptic Transfer Technology: Weighing Up the Advantages of Varying Approaches for Sterile Drug Manufacturing

The author reviews current approaches to sterile containment and compares several sealed transfer and barrier techniques, including isolators, restricted access barrier systems, and split butterfly valve technology.
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| PROCESS CONTROL |

Moving Toward Unified Process Control for Biopharma

Traditional barriers between upstream and downstream bioprocessing are slowly starting to break down, as biopharma embraces more advanced analytics and process control.
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| PARTICLE CHARACTERIZATION |

Testing Foreign Particulate Matter in Inhaled Products

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates in inhaled drug products.
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| PACKAGING |

Selecting Primary Packaging for Parenterals

Traditional glass and polymeric materials compete for market share in primary packaging for parenteral drug products.
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| SUPPLY CHAIN |

Serialization: Scaling Down for the Final Stretch

Vendors are offering template-based models and direct data-filing services to help smaller companies meet imminent deadlines.
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| EU REGULATORY WATCH |

Collaboration on GMP Inspections Has Been Successful but Challenges Exist

EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.
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| OUTSOURCING |

Fifteen Years of Progress: Biopharmaceutical Industry Survey Results

This article highlights 15 years of changes in biopharmaceutical manufacturing.
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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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