| SUPPLY CHAIN |

Synchronizing Anticounterfeiting Efforts

Serialization and complementary authentication technologies are needed in order to meet DSCSA and FMD regulations.
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Decoding Serialization Regulations

The author discusses upcoming serialization and transaction data collection regulations including the US Drug Supply Chain Security Act, the European Union Falsified Medicines Directive, and the EU Delegated Regulation.
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| FORMULATION |

Particle Size Reduction for Investigational New Drugs

Modern air jet milling can be used to investigate the feasibility of micronization as a solubilization approach in formulation development.
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| QUALITY |

Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ Batches

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
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| FACILITY DESIGN |

Facility Design Issues for Single-Use Processes

Single-use systems demonstrate advantages over stainless-steel systems for biopharmaceutical manufacturing facilities.
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| EQUIPMENT AND OPERATIONS |

New and Updated Laboratory Equipment Optimize Efficiency

The past several months have seen new product releases and updates made to already available laboratory equipment.
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| DISSOLUTION TESTING |

Understanding Dissolution Testing

Industry experts discuss best practices for dissolution testing of poorly soluble, immediate-release, and controlled-release formulations and the different analytical approaches used.
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| INHALATION DRUG MANUFACTURING |

Extractables and Leachables Testing for Inhaled Medicines

Follow guidelines for E&L studies of an orally inhaled and nasal drug product formulation in its delivery device
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| STATISTICAL SOLUTIONS |

Do You Listen to What Your Data are Telling You?

This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.
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| OUTSOURCING OUTLOOK |

Update on Continuous Bioprocessing: From the Industry’s Perception to Reality

Although widespread adoption of continuous bioprocessing has been slow, some processes have been an exception.
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| GUEST EDITORIAL |

Drug Spending Not Driving Rising Health Care Costs

New reports indicate that drug prices are slowing compared to other healthcare costs.
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| US REGULATORY WATCH |

Efficient Manufacturing Critical for Accelerated Drug Development

Approval of breakthrough therapies requires expedited quality assessment.
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| ASK THE EXPERT |

Ensure Quality in a Contract Test Laboratory

Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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| PRODUCT SPOTLIGHT |

Planetary Dispersers with PLC Recipe Controls

The Ross PowerMix Planetary Dispersers with PLC Recipe Controls from Ross, Charles & Son deliver batch-to-batch consistency in the mixing of high-solids, high-viscosity applications.
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Paperless Recorder Shortens Sampling Intervals

The SMARTDAC+ GX series panel-mount type paperless recorder from Yokogawa Electric Corporation comes with new functions, including sampling intervals as short as one millisecond and the control and monitoring of up to 20 loops.
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Sterilizer Uses Pulsed Light Technology

The Robotic Pulsed Light Sterilizer (RPLS1) from Steriline uses pulsed light technology for ready-to-use nest sterilization and can sterilize tubs of syringes, vials, and cartridges.
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Control Box Connects Lab Sensors and Pumps

The Easy Control Box from Mettler Toledo connects any lab sensor and pump to make real-time measurement and controlled dosing available to non-experts.
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