| SOLID-DOSE MANUFACTURING |

Blending Trace Ingredients

Homogeneity of the powder blend is crucial for solid-dosage drug manufacturing.
read more

| CLINICAL TRIAL MANUFACTURING |

Orchestrating Success in Clinical Trial Manufacturing

Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.
read more

| ANALYTICS |

Accepting the Challenge of Protein Characterization

Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.
read more

| CGMPS |

FDA Steps Up Enforcement of cGMPs for OTC Drugs

Senior managers of OTC drug companies are on a learning curve, as FDA warning letters cite insufficient understanding of cGMPs and inadequate responses to prior 483s.
read more

| ANALYTICAL LAB OPERATIONS |

Best Practices in the QC Micro Laboratory

Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.
read more

| SUPPLY CHAIN |

Real-Time Monitoring Drives New Logistics Solutions

As patient-centered therapies and clinical trials become more important, innovation is providing more control and transparency in the way that pharmaceuticals are delivered.
read more

| PEER-REVIEWED RESEARCH |

Quantitation of Mutagenic Impurities in APIs Using a Platform Chip-Based CE–MS Method

The ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.
read more

| FROM THE EDITOR |

The Moon, the Stars, and the Science Lab

Fifty years after the man walked on the Moon, space-based science is benefiting Earth.
read more

| US REGULATORY WATCH |

FDA Maps Strategies to Advance Cell and Gene Therapies

New tools and policies aim to support more complex manufacturing processes.
read more

| ASK THE EXPERT |

Quality Risk Management Plans Create Effective Quality Systems

Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
read more