FROM THE EDITOR

What Is the Industry Underestimating About An ADC Supply Chain? – Part 2

In this article, Dan Bell, vice president of regulatory compliance and technical affairs for Marken, discusses regulatory challenges, and both he and Nathan Ihle, Ph.D., VP of CMC Strategy and Management at Seattle Genetics, offer best practices to apply when planning your ADC supply chain.

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PHARMA MANUFACTURING INSIGHTS

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    End-To-End Solutions For Critical H1N1 Vaccine Deliveries

    Partner with 3PL client to orchestrate the critical delivery of millions of doses of temperature-sensitive vaccine to key locations and waiting patients around the world. Without a baseline, there were unique logistical challenges in creating the best cold chain system to ensure product integrity.

  • Distributing Temperature-Sensitive Pharmacueticals Is A Risky Business
    Distributing Temperature-Sensitive Pharmacueticals Is A Risky Business

    It is evident when reviewing the Good Distribution Practice guidelines that there has been a shift in emphasis towards Risk Management in the distribution of temperature-sensitive pharmaceuticals. Whether it’s the publication of the recent EU guidance, the revisions from USP or the PDA’s technical report 58, there can be no mistaking one thing - shippers and manufacturers are ultimately responsible for examining their supply chains using a ‘risk-based’ approach.

  • 5 Misconceptions About Global Shipping Of Temperature-Sensitive Products
    5 Misconceptions About Global Shipping Of Temperature-Sensitive Products

    It’s no secret that drug development has undergone explosive global growth over the last decade. But is there a secret to moving time- and temperature-sensitive products seamlessly across the globe? What are the critical considerations for global specialty logistics — and how do they differ from country to country? Let’s explore five misconceptions about shipping internationally.

  • The Impact of Well-Designed Weighing Processes On Product Quality
    The Impact of Well-Designed Weighing Processes On Product Quality

    Companies involved in the production of pharmaceutical products are well aware of the importance of consistency and accuracy in manufacturing processes. Batches that fail quality inspections waste time, labor, effort, and resources. This further leads to a loss in profits and market reputation, as well as compromises human health and safety.

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PHARMA CONTRIBUTING EDITORS

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  • Cold Chain Open House 2014 Webinar
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  • rommelag USA, Inc.
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  • Alconox, Inc.
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