• Analytical QbD at Teva: Knowledge Is Power Only When You Share It
    Analytical QbD at Teva: Knowledge Is Power Only When You Share It

    Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.

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    You need to transport high-value, specialty or clinical trial products around the world. You know that shipment integrity is essential—that you can’t afford temperature excursions resulting from a shipment getting delayed in customs, that shipments gone awry can result in devastating losses for your organization.

  • New Requirements In Global Clinical Supply Spur Evolution And Innovation
    New Requirements In Global Clinical Supply Spur Evolution And Innovation

    Who knew clinical trial logistics had so much in common with the automotive and high-tech industries? That certainly seems to be the case with trends like just-in-time (JIT), customer-managed inventory (CMI) and vendor-managed inventory (VMI).

  • Big Pharma Vetran, Peter Bigelow, Will Help “Tell It Like It Is” At Outsourced Pharma West
    Big Pharma Vetran, Peter Bigelow, Will Help “Tell It Like It Is” At Outsourced Pharma West

    Peter Bigelow is both excited and motivated for Outsourced Pharma West in San Francisco November 10-11, by the targeted subject (drug development and manufacturing outsourcing) and streamlined format (all panelist and attendee discussion; no presentations).

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    Recommended Mixing Equipment For Fish Oil Supplements

    Food and pharmaceutical manufacturers rely on a range of high speed mixers to accomplish emulsification. In the processing of fish oil supplements, for instance, High Shear Mixers are used to prepare emulsions under 10,000 centipoise (cP).

  • Scaling Up For Biopharmaceuticals
    Scaling Up For Biopharmaceuticals

    Biopharmaceuticals are at the forefront of medical research, and there is no doubt that demand is increasing for bio-based vaccines, hormone- and protein-based drugs, and gene- and cell-based therapies. Dallas, Texas-based research firm Market and Markets predicts the U.S. biopharmaceutical market will reach $144 billion by 2016, having shown 11.2 percent annual growth since 2009. However, the marked increases in development and commercialization, along with increases in production yield and efficiency, mean biopharmaceutical manufacturers face challenges in processing and packaging.

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    A message to biotech start-ups, scientist-entrepreneurs and life sciences organizations banking on your exciting protein-based drug-discovery programs and technologies: When it comes to the timing of your investment, if you don’t pay now, you might pay (much) more later. 

  • Industry Insights From The Executive Director Of Compliance At Seattle Genetics

    Kristin Rand always had a fascination with questions science had not yet answered, and she developed an interest in genetics while still in high school. She obtained an undergraduate degree in the Diagnostic Genetic Sciences program at UCONN. FDA law and bioethics were the focus of her graduate degree in law, and she later earned a master degree in industrial-organizational psychology.

    After serving in various positions at Wyeth and Genentech, she landed at Seattle Genetics, where she currently serves as executive director of compliance. In this piece she discusses trends in pharma compliance, and challenges companies can expect to face in 2014 and beyond.

  • WIB Profile - bluebird bio Scientist On 10 Years Of Performing Tech Transfers

    Kelly Kral has worked in the pharmaceutical industry for more than 10 years. She started her career at Genzyme, working as a process engineer developing a fed batch process for the production of adenovirus in HEK293 suspension cells. Her responsibilities included media screening, cell growth characterization, and virus production in shake flasks, spinners, and bioreactors. She assisted in process transfer to a CMO and authored process documentation, skills she used extensively in her work as group leader for upstream process development at Percivia and in her current role of scientist I at bluebird bio.

  • Pharmaceutical Customers In An Outsourcing Provider Merger -- Part 3 Of Interview With CEO of Newly Formed DPx Holdings B.V.

    This final article in our series featuring Jim Mullen, CEO of newly formed DPx Holdings B. V., discusses how to keep the focus on customers during M&A activity, and the broader transformation of sponsor–provider relationships in the pharmaceutical outsourcing industry.

  • eTMF Survey: Lagging Technology Adoption Will Impact Clinical Trials

    When you think of the pharmaceutical industry, you probably do not picture firms that are anxious to jump on new technologies, or willing to adopt new tools that have not been proven successful. New technologies are now available to facilitate the collection of data in clinical trials, yet Big Pharma and CROs are not climbing over one another to be the early adopters. So is it really surprising that with electronic trial master files (eTMF) now available to clinics, and bearing the blessing of the FDA, that many sites continue to amass large volumes of paper?

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  • Introduction to Pharmaceutical Bag Filling and Sealing Equipment
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    Umbra bag filling and sealing machinery for all sorts of dry products in the food, pharmaceutical, chemical, and agricultural industries. A single Umbra packaging machine can fill bags of any material with varying fill weights and with different closure techniques, providing an extremely versatile solution to customers looking for high flexibility.

  • What Is mHealth? Video
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  • PTI Inspection Overview Video
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    Video overview of PTI’s non-destructive inspection solutions for leak detection, seal integrity, package integrity and container closure integrity testing. We manufacture technologies ranging from high voltage leak detection (HVLD), vacuum decay, to airborne ultrasound.

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  • Southwest Airlines Cargo
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    The integrated resources of Hach help you monitor compliance to pharmaceutical water and cleanroom facility standards. Our world-renowned instrumentation combined with our associates' expertise gives you the confidence to move towards parametric release and process peace of mind.

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