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  • ICH Q2 – the Challenge of Measuring Total Organic Carbon In Modern Pharmaceutical Water Systems
    ICH Q2 – the Challenge of Measuring Total Organic Carbon In Modern Pharmaceutical Water Systems

    Total Organic Carbon (TOC) is one of the quality attributes defined in the European and USA pharmacopoeias for pharmaceutical waters. Modern water treatment systems can deliver such high purity water that TOC levels can be consistently close to zero and very difficult to measure with any accuracy. This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document from the International Conference on Harmonisation.

  • Enhanced Assurance Of Supply For Single-Use Bags
    Enhanced Assurance Of Supply For Single-Use Bags

    Single use bags’ growing adoption in the commercial production of biopharmaceutical drugs raises new challenges like consistent product quality, improved assurance of supply, robust change management and business continuity planning. By Jean-Marc Cappia, Elisabeth Vachette, Carole Langlois, Magali Barbaroux, and Heiko Hackel

  • Marken Delivers Medicine To Help Save A Child’s Life
    Marken Delivers Medicine To Help Save A Child’s Life

    It is 11 p.m. on a Wednesday in early September 2014, and a child at Mater Children’s Hospital in Brisbane, Australia is critically ill and in immediate need of a drug available only in the United Kingdom. The drug needed to save this child must consistently remain at 2-8oC in order to maintain efficacy. To further complicate the situation, quick routes with direct flights from the U.K. to Brisbane are very limited, and the pharmacy originally designated for delivery of the shipment is unable to accept weekend deliveries.

  • New Technologies Drive Efficiencies In Drug Processing And Packaging
    New Technologies Drive Efficiencies In Drug Processing And Packaging

    By Julie Ackerman, senior director PR and communications, PMMI, The Association for Packaging and Processing Technologies

    Pharmaceutical manufacturers continually seek solutions to speed products to market, ramp up production in times of outbreaks or increased demand, protect their brand integrity throughout the supply chain and streamline efficiencies to remain highly cost-effective. Of course, the critical need to ensure patient safety makes rigorous quality control and precision in pharmaceutical manufacturing incredibly important.

  • A Global Forum For Outsourcing (With Simple Objectives)
    A Global Forum For Outsourcing (With Simple Objectives)

    Perhaps the best advice I’ve heard regarding industry conferences is twofold: first, make sure you attend, and second, keep your objectives for attending simple.

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  • Pfizer Issues A Challenge – Cook Pharmica Delivers

    When Pfizer approached Cook Pharmica about producing a monoclonal antibody, Cook saw it as an opportunity to demonstrate its ability to deliver a product to the specifications the sponsor desired. Cook was fairly new at the time, and had been working with clients for just over four years. The company looked good on paper, and was one of a few facilities that could produce ingredients as well as final drug products in the same facility. Still, Cook executives knew they needed to prove they could measure up to the six driving principles (quality, cost, timeliness, adaptability, timeliness, and risk) that were crucial to Pfizer.

  • 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.

More From Pharma Contributing Editors


  • Introduction to Multivariate Data Analysis
    Introduction to Multivariate Data Analysis

    Brad Swarbrick, Vice President of Business Development at CAMO Software, gives a short introduction to multivariate data analysis, discusses some of its applications and how these powerful analytical tools are being used to improve products and manufacturing processes in a wide range of industries.

  • 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.

  • 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.

More Videos


  • World Courier Management
    World Courier Management

    World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.

  • Beckman Coulter Life Sciences
    Beckman Coulter Life Sciences

    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.

  • Lighthouse Worldwide Solutions
    Lighthouse Worldwide Solutions

    Lighthouse has the most complete line of particle counting and contamination monitoring solutions available. Including airborne particle counters, liquid particle counters, microbial samplers, facility monitoring systems





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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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Surviving a FDA GCP Inspection – Preparation Techniques for Success

October 2, 2014
1pm-2:30pm EDT, Online Training

Protocol Deviations: Calculated Risk or Risk to be Managed?

October 6, 2014
1pm-2:30pm EDT, Online Training

FDA Guidance on Social Media: Questions Answered and Unanswered

October 8, 2014
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FDA GMP Inspections – Proven Preparation & Survival Techniques

October 9, 2014
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