FROM THE EDITOR

  • How To Prepare A Facility For The Biopharmaceutical Revolution
    How To Prepare A Facility For The Biopharmaceutical Revolution

    Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. Patheon facility in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?

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PHARMA MANUFACTURING INSIGHTS

  • Lessons Learned In The Ballroom: Predicting Pharma Disposable Facilities
    Lessons Learned In The Ballroom: Predicting Pharma Disposable Facilities

    This article presents an alternative approach to the ballroom concept. It studies the lessons learned from the operation of recently commissioned facilities to predict what the next generation of disposables plant could look like. Will the “Dance Floor” concept be the next step in the evolution of fully disposable facilities? By David A. Wolton and Andy Rayner

  • How To Select The Appropriate Flooring System For Your GMP Facility
    How To Select The Appropriate Flooring System For Your GMP Facility

    By Eric Bohn, Partner, Jacobs Wyper Architects

    In today’s construction industry, there is an overabundance of flooring materials available for installation in your facility. The quality, cost, and functionality of these options vary wildly. You can run down to your local home improvement store and purchase vinyl tile for less than $1/square foot or spend over $20/square foot for specialty products of exceptional quality and durability. With so many choices, it is not always easy to know which flooring system is appropriate for your cGMP facility. 

  • Reveleris® Technologies: A Full Spectrum Of Purification Solutions
    Reveleris® Technologies: A Full Spectrum Of Purification Solutions

    Take control of your purification with the Reveleris® Prep purification system.

  • Is The SDV In Risk-Based Monitoring Misunderstood?
    Is The SDV In Risk-Based Monitoring Misunderstood?

    What’s in a name?  Not much according to Shakespeare.  But the man who penned “A rose by any other name would smell as sweet” was a 16th century poet and playwright, not a 21st century clinical research professional.  For us, names matter.  Despite recent efforts to standardize the definition of Source Data Verification (SDV), the term still means different things to different people, and that needs to be navigated very carefully. By Laurie Meehan, Polaris Compliance Consultants

     

  • Innovation In Drug Delivery To Meet Patient Needs
    Innovation In Drug Delivery To Meet Patient Needs

    Today’s patients are being afforded access to life-saving medicines wherever they are, thanks to innovation in drug delivery methods and the efforts of medicine manufacturers that are shifting operations to produce easier-to-use delivery systems as well as medicines that are more customized to meet the needs of specific patient groups. 

More Pharma Mfg Insights

PHARMA CONTRIBUTING EDITORS

  • Women In Bio Profile - Lessons Learned From 10 Years 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?

  • 7 Essential Steps To Hiring A Pharmaceutical Consultant

    In preparation for the spring 2014 hiring season, The CECON Group has recently developed guidelines for choosing the best consultant for a project. Selecting and managing a technical consultant can be a challenge, especially if the subject matter is well outside of the hiring manager’s field of expertise. In the pharmaceutical industry, consultants can help companies of any size to deal with various aspects of drug development, including the selection of suppliers and outsourcing partners.  

  • Women In Bio Profile: Industry Insights From The Executive Director Of Compliance At Seattle Genetics

    From the time she was young, Kristin Rand’s mother said she would be an actress or a lawyer. Although she thought her mother was probably correct, she didn’t like the prospect of becoming either, merely because she did not want her mother to have predicted her future. While in high school she developed an interest in genetics and the promise it held for the future of personalized medicine. Rand notes she always had an interest in the questions that science had not yet answered.  

    She began her collegiate career at Fordham University as a pre-med student but was not sure she would want to go to medical school after graduation. She opted to pursue a specialized undergraduate degree, eventually transferring to UCONN and landing on their Diagnostic Genetic Sciences Program. When she later decided to go on to graduate work, the choice was between a degree in law or molecular genetics. She chose law and finally succumbed to what her mother always felt she was naturally inclined to do. She made FDA law and bioethics the focus of her training. After working in medical communications, education, and legal for various vendor companies, she moved over to the pharma side of the house. Her first position was with Wyeth, prior to its acquisition by Pfizer. The dynamics of working in such a large and complex global organization again peaked her interest, and was the impetus for her returning to school, this time to secure a masters degree in industrial-organizational psychology.

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.

  • Online Continuous Motion Leak Tester For Efficient Container Handling

    The VeriCon 135 is a single station continuous mtion leak tester with feedscrew for efficient container handling and control.

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FEATURED SUPPLIERS

  • Nilfisk Industrial Vacuums
    Nilfisk Industrial Vacuums

    Nilfisk CFM is leading the industry in manufacturing the safest, most powerful potent compound vacuums, HEPA vacuums, and ULPA vacuums available. Our vacuum solutions range from portable, intermittent-duty models for general cleaning to continuous-duty models for process-integrated applications and central vacuum systems.

  • Infitrak, Inc.
    Infitrak, Inc.

    Infitrak is a leader in cold chain compliance services, packaging and intelligent monitoring solutions for the pharmaceutical, healthcare, food and life sciences industries.

  • Thermo Scientific Product Inspection
    Thermo Scientific Product Inspection

    Thermo Scientific Product Inspection equipment protects your brands by ensuring the quality and safety of your products. With more than 50 years of making sure little things don't turn into big problems, we know that little things can make a big difference in your bottom line.

  • Natoli Engineering Company, Inc.
    Natoli Engineering Company, Inc. Punches & Dies|Tablet Presses|Tablet Design Software|Tablet Replacement Parts|Tablet Press Accessories

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