| API SYNTHESIS AND MANUFACTURING |

Managing Potentially Potent APIs

CDMOs have established strategies for handling new chemical entities with unknown biological activity.
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| SOLID-DOSAGE DRUGS |

Choosing Capsules: A Primer

Capsules offer certain benefits over tablets for oral-solid dosage drugs, and several types of capsules are available.
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Is Your Tablet Hard to Swallow? Guidance Addresses Drug Tablet Design

EMA and FDA guidance encourages design of drug products to improve patient compliance.
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| SINGLE-USE BIOREACTORS |

Testing and Simulation Approaches for Single-Use Bioreactor Scale-up

Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.
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| EXCIPIENTS |

The Real Complexity of Excipient Composition

This article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.
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| FDA AUDITS |

Teaming Up for FDA Inspections

Just as FDA strengthens ties between reviewers and plant inspectors, proactive manufacturers are involving different disciplines in preparation for FDA audits.
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| ANALYTICS |

Automated Visual Particle Inspection

This article discusses fully automatic inspection of glass and plastic containers and factors that affect particle detection rate.
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| PROCESS OPERATIONS |

Reinventing Lean Six Sigma for the Pharmaceutical Industry

Instead of rigidly applying statistical tools, experts suggest that pharma embrace statistical thinking, but focus on reducing variability and adding value for patients.
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| STATISTICAL SOLUTIONS |

Singlet Determination Revisited

Is there a difference between a specification and a standard?
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| PACKAGING |

Improved Materials Enhance Parenteral Packaging

Manufacturers introduce innovations in glass and plastic packaging for injectables.
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| REGULATORY WATCH |

FDA User Fees Promote Manufacturing Readiness

Industry and FDA face new fee structures and new challenges in implementing fee initiatives.
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Pharmaceutical Environmental Pollution and Antimicrobial Resistance

The European Commission is striving to tackle environmental pollution by pharmaceuticals as a means of curbing antimicrobial resistance.
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| OUTSOURCING OUTLOOK |

Up and Away, M&A

Mergers and acquisitions are positive for the CDMO industry, but there is a downside.
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| ASK THE EXPERT |

Making Decisions Based on Risk

Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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| FROM THE EDITOR |

Pharma's Role in Puerto Rico's Future

Reeling from financial and tropical storms, Puerto Rico needs stable industry for recovery.
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