FROM THE EDITOR

  • Tools for the Design of Vaccines to Help Reduce Clinical Failure
    Tools for the Design of Vaccines to Help Reduce Clinical Failure

    If you are involved in the pharma industry, then you are interested in saving lives. In the area of preventative medicine, therapeutic vaccines have proven to have a tremendous impact on the ability to save millions of lives. Similar to pharmaceuticals, vaccine development can take over 10 years and less than 10 percent of candidates reach commercialization. Reducing the cost of failure and increasing the chances of clinical success for vaccines is beneficial to both the pharma industry and those being treated for or protected from disease.

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OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION

  • A Witness To The History of Outsourcing
    A Witness To The History of Outsourcing

    Joe Guiles seems too young and mild-mannered to have been at the outbreak of a revolution that began many years ago. But he witnessed firsthand the inception of what would become the complete penetrability of outsourcing throughout the drug industry. 

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PHARMA MANUFACTURING INSIGHTS

  • Rouge & Biofilm: Compounding Cleaning Challenges
    Rouge & Biofilm: Compounding Cleaning Challenges

    Rouge may facilitate the development of more tenacious biofilms. Both rouge and biofilm represent cleaning and decontamination challenges to manufacturers. By Michael Gietl and Paul Lopolito

  • Electronic Drug Accountability Systems: Ensuring Compliance, Safety, And Data Integrity In Clinical Trials

    By Stefan Duerr, Associate Director Of Project Management, Cenduit

    Clinical trial sites, both foreign and domestic, have been subjected to an increasing number of FDA audits in recent years. Federal investigators cite non-compliance with federal drug accountability regulations as one of the most common problems found in site audits.1,2 A failed site audit is a serious problem for a clinical trial, leading to costly delays, non-approval of the investigational drug, or criminal liability.2,3 Ensuring compliance with federal regulations is key to the success of a clinical trial and the entire drug development program.

  • "Every 483 Observation Has A Training Component"
    "Every 483 Observation Has A Training Component"

    “Every 483 observation has a training component.” Truer words have never been spoken—I only wish it was me who said them. An FDA inspector I heard at a conference almost 15 years ago made this statement, and it forever changed how I look at 483 observations. I’ll admit up front that I have a bias towards training—after all, it’s what I do.  Others don’t necessarily share that bias, being that often training isn’t done well, isn’t timely or effective, isn’t always meaningful. I’ve heard the arguments and can even agree with some of them. But let’s set that aside for now and look at what the inspector meant.

  • Troubleshooting Load Cells

    When we have a problem with our weighing system and have to do some troubleshooting, where do we start? A good place to start is the load cell. By Dominic Barbuto, Sartorius Intec

  • Is Portable Tank Weighing Possible?

    Not only is portable tank weighing possible, but so is highly accurate portable tank weighing. In order for a portable tank system to have high system accuracy, it must have a rigid foundation that does not flex or bow, regardless of external influences. By, Steve Watson, Sartorius Intec

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PHARMA CONTRIBUTING EDITORS

  • Are Regulators Providing The Right Quality Incentives?

    If you want to get a horse to move, there are two schools of thought on how to get it done. One says stand behind the animal with a stick and hit it until it does what you want. This method is not the most humane, and would not do much to endear you to the horse. The other approach says hold a carrot in front of the horse, and get it to move of its own volition. The carrot would be a reward to the animal for doing the right thing.

    Looking at this situation in a different context, we all want quality outcomes in pharmaceutical manufacturing facilities. Good manufacturing practices will provide safe products to patients, prevent injury to workers, and minimize or eliminate plant shutdowns, which can ultimately lead to drug shortages. Guy Villax, CEO of CMO Hovione, believes the FDA and other regulatory agencies have many tools at their disposal that can be used to hit manufacturers for poor quality practices. In the future, he would like to see the oversight agencies make more use of carrots to get manufacturers producing to the standards that would benefit the entire industry.

  • Patheon Surfs Outsourcing Waves And Scoops Up Gallus Along The Way

    Jim Mullen, CEO of Patheon parent company DPx Holdings B.V., is at it again.

    On the heels of my three-part series with Mullen on the details behind the springtime merger of his company and the pharmaceutical products division of Royal DSM, he has made his next move.

    This time it is a strategic entrée into the U.S.-based market for biologics services via an acquisition of privately held Gallus BioPharmaceuticals. With Gallus, Patheon adds new capabilities at well-established sites with name-brand clientele, in St. Louis, Mo. and Princeton, N.J., to its global locations in Groningen, the Netherlands and Brisbane, Australia.

  • When To Invest In Protein Production: The Risk-Reward Calculation

    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.

  • 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.

More From Pharma Contributing Editors

PHARMACEUTICAL ONLINE VIDEOS

  • Introduction to Pharmaceutical Bag Filling and Sealing Equipment
    Introduction to Pharmaceutical Bag Filling and Sealing Equipment

    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
    What Is mHealth? Video

    AT&T mHealth Solutions are on the cutting edge of transformation in healthcare and offer solutions that enable health enterprises to engage patients, improve outcomes and lower costs.

  • AT&T mHealth Platform Video
    AT&T mHealth Platform Video

    The AT&T mHealth Platform enables enterprises and developers to rapidly develop, launch and scale enterprise and patient centric healthcare solutions. By providing a comprehensive infrastructure for the sharing of health information across healthcare enterprises, patients, and clinical professionals in a highly secured environment designed to meet HIPAA and HITECH security and privacy requirements.

  • PTI Inspection Overview Video
    PTI Inspection Overview Video

    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.

  • Real-Time Information On Microbial Contamination In Pharma Cleanrooms
    Real-Time Information On Microbial Contamination In Pharma Cleanrooms

    The BIOTRAK® Real-Time Viable Pharmaceutical Particle Counter from TSI provides real-time information on microbiological contamination in pharmaceutical cleanrooms.

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FEATURED SUPPLIERS

  • Southwest Airlines Cargo
    Southwest Airlines Cargo

    At Southwest Airlines Cargo®, we understand the urgency of pharmaceutical shipments and know that sometimes overnight is not an option. With Relentlessly Reliable® air cargo service to over 90 destinations, we provide exceptional care so your time critical shipment will arrive ontime, as planned.

  • Natoli Engineering Company, Inc.
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    Multisorb Technologies Multisorb Technologies is the world leader in active packaging technology, providing sorbent solutions for managing moisture, oxygen, odor, hydrocarbons and other volatiles in healthcare product packaging. As a long time supplier to the healthcare industry, Multisorb’s products are extensively used to ensure the stability of pharmaceutical, in-vitro diagnostic, medical device, dietary supplement and drug delivery products.
  • AT&T
    AT&T

    AT&T Inc. (NYSE:T) is a premier communications holding company and one of the most honored companies in the world. Its subsidiaries and affiliates – AT&T operating companies – are the providers of AT&T services in the United States and internationally. With a powerful array of network resources that includes the nation’s fastest and most reliable 4G LTE network, AT&T is a leading provider of wireless, Wi-Fi, high speed Internet, voice and cloud-based services.

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PHARMA EXPO 2014

As the highly anticipated November debut of Pharma EXPO approaches, we’ve developed this resource center for our readers to access the most relevant information about the event. 

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