| API SYNTHESIS AND MANUFACTURING |

Conjugation Chemistry with Highly Potent Compounds

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.
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| PRODUCT QUALITY |

Ensuring Quality in Solid and Semi-Solid Dosage Forms

Industry experts and FDA’s Office of Pharmaceutical Quality discuss the challenges, trends, and regulations involved in ensuring quality in solid and semi-solid dosage forms.
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| FILTER INTEGRITY TESTING |

Failure Mode Effects Analysis for Filter Integrity Testing

Understanding of the risks associated with FMEA is crucial in lot release testing.
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| SHIPPING SERVICES |

Shipping: Proactive Risk Management

Technology is making it easier to stop problems before they can affect patients and the bottom line.
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| PEER-REVIEWED RESEARCH |

Concept Design for Establishing an Eco-Friendly Pharmaceutical Production Facility in Malta

The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.
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Ruggedness of Visible Residue Limits for Cleaning Validation

Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.
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| PACKAGING FORUM |

Blister Pack Optimization

Science-based software and testing services expedite the material selection process and ensure blister packs deliver adequate barrier protection for solid-dosage forms without over-packaging.
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| FROM THE EDITOR |

More Outsourcing? More Monitoring.

A global API marketplace increases the burden of supply chain monitoring for drug companies.
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| TROUBLESHOOTING |

Understanding Measurement Uncertainty in Weighing: Balance Calibration

A program for calibration and routine testing of weighing instruments ensures accurate results.
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| OUTSOURCING OUTLOOK |

CMC Development is Hot

Demand is driving expansion and consolidation of formulation and clinical trial materials services.
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| REGULATORY WATCH |

Vaccine Development Faces Urgency and Challenges

Global outbreaks energize vaccine R&D and drive production modernization.
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| ASK THE EXPERT |

Requirements for Product Technology Transfer

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss requirements for successful product technology transfer.
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| Webcasts |

Monoclonal Antibody Purification by Protein A Affinity and Hydroxyapatite Mixed Mode: Multi-Column Continuous Chromatography

On Demand
Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process.
Sponsored by Tosoh Bioscience

Establishing a Risk Management Plan for Compliance and Pharmacovigilance

On Demand
Risk Management Plans have become a cornerstone in the pharmacovigilance of new drugs. It was introduced to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. In this webinar, EtQ and HighPoint Solutions will cover the regulations around the European Medicines Agency’s Risk Management Plan and also the FDA's Risk Evaluation and Mitigation Strategy.
Sponsored by EtQ