| FORMULATION |

The Case for Extended Dwell Flat Tooling

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.
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| PEER-REVIEWED RESEARCH |

Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating Tablets

This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.
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| MANUFACTURING |

Exploring a Modern Control Strategy for Wurster Coating

A process control system based on PAT can compensate for variations in particle size, resulting in more consistent coating thickness.
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| QUALITY|

Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory Template

A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
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| EXTRACTABLES AND LEACHABLES |

E&L Risk Assessment for Biologic Drug Products

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.
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| SUPPLY CHAIN |

Reducing the Risk of Pharma Air Transport

Air transport continues to be the most secure way to ship valuable therapies, but it is also the riskiest. Standards are helping to improve service quality.
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| OUTSOURCING ANALYTICS |

Outsourcing Glycan Analysis

Industry experts discuss the challenges of performing glycan analysis and how companies can gain specific expertise from outsourcing partners.
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| FROM THE EDITOR |

FDA Is Not Playing Games with Biosimilars

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.
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| US REGULATORY WATCH |

FDA Seeks to Revive Quality Metrics Initiative

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
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| ASK THE EXPERT |

Submitting Extractables and Leachables Data to Regulators

The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.
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