| ANALYTICAL TESTING |

Forced Degradation Studies for Biopharmaceuticals

The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.
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| QUALITY |

Pharmaceutical Quality: Where Do We Need to Go from Here?

As the pharmaceutical industry moves toward continuous manufacturing, new documents are needed to provide flexible guidance that meets the new process requirements.
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| SCALE-UP STRATEGIES |

Practical Approaches to Tech Transfer and Scale-up of Lyophilization Processes

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.
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| INSIDE EDQM |

Significant Revisions and Updates to the European Pharmacopoeia

Revisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.
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| FORMULATION |

A QbD Method Development Approach for a Generic pMDI

Application for sirdupla uniformity of delivered dose methodology.
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Tackling Moisture Challenges in Solid Dosage Manufacturing

Armin Gerhardt, associate professor of Pharmaceutical Science, Concordia University Wisconsin School of Pharmacy, discusses the effects of moisture on product quality and how to achieve good control of moisture during pharmaceutical manufacturing operations.
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| API SYNTHESIS & MANUFACTURING |

Upstream and Downstream Operations Can Impact Biologic API Uniformity

Bioprocess operations—from cell line selection to final filtration—can influence the consistency and purity of biologic drug substances.
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| TROUBLESHOOTING |

Choosing Containment Strategies For Highly Potent APIs

Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies. Engineering controls are the first line of defense in handling HPAPIs. Engineering controls reduce risk in HPAPI handling.
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| REGULATORY WATCH |

FDA and Manufacturers Seek Safer Pain Medications

The campaign against opioid abuse opens door to more innovative therapies.
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| TRACK AND TRACE |

Waking up to Track-and-Trace Benefits

With deadlines only a few years away, some companies have not started serialization programs, while others are taking a tactical, short-term approach, losing out on potential business benefits.
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| GUEST EDITORIAL |

The Value of Saving Lives

Policies for patient access to life-saving therapies must keep pace with biomedical innovation.
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| OUTSOURCING|

Outsourcing of Biomanufacturing in 2016

Growth may be slowing, but outsourcing activity remains healthy.
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| ASK THE EXPERT |

Reporting Quality Metrics to FDA

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
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| PRODUCT SPOTLIGHT |

Penetrometer for Quality Monitoring

The penetrometer PNR 12 from Anton Paar, used for quality monitoring, features the Pharma Qualification Package--Smart PNR 12, which fulfills GMP and United States Pharmacopeia (USP) <1058> regulations and can be used to perform qualification processes.
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Operator Stations Ensure Functionality

The NEMA 4X Operator Stations, from Ross, Charles & Son, include a 15-inch color touchscreen with Ethernet communications and emergency stop button with hermetically sealed contact block.
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Filling and Closing System Reduces Decontamination Cycle

The FlexPro 50, from Groninger, is a modular filling and closing system designed to process vials, cartridges, and syringes, as well as vials in bulk and trays.
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Ultracentrifuge Allows for Multi-Wavelength Analysis

The Optima AUC from Beckman Coulter Life Sciences is an ultracentrifuge that determines molecular weight, size shape, and polydispersity.
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| Webcasts |

Strategies to Accelerate Early Phase Clinical Trials

On Demand
Learn about adaptive clinical trials, patient recruitment strategies, and advanced biomarker analysis tools designed that can accelerate drug development and clinical testing processes.
Sponsored by SGS

Building the Future: Using Simulation Effectively

On Demand
Join our free webinar for a case study on the handling of complex manufacturing expansion projects, with insight on simulation and visualization tools, innovations for manufacturing of parenterals, effective team building, and more.
Sponsored by Baxter