• Merck’s Vision Behind Award-Winning Technology And Partnership For High Throughput Upstream Process Development
    Merck’s Vision Behind Award-Winning Technology And Partnership For High Throughput Upstream Process Development

    Automation and disposable technology have offered considerable efficiency improvements to speed cell line development; however, a major challenge with process development for biologics is how labor intensive it can become.  Many different interactions and parameters can impact product quality and product titer, which typically requires iterative rounds of statistical experimentation using up to 20 reactors or more per study. For cell culture mAb processes, this development work can take three to four months to complete, which adds considerable cost for a company in multiple ways. Because of this challenge, Dr. David Pollard, executive director of BioProcess Technology & Expression, BioProcess Development at Merck, and his dedicated technology group wanted to see how the benefits of automation and disposable technologies could be translated into tools to drive high throughput upstream process developmen

More From The Editor


More Pharma Mfg Insights


  • The Challenge Of Managing Regulatory Submissions & Correspondence

    Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.

    Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.

  • ISPE Releases Drug Shortages Prevention Plan At Annual Meeting

    ISPE has released its Drug Shortages Prevention Plan at a media conference held during its annual meeting at Caesars Palace in Las Vegas. Present at the conference were new president and CEO John Bournas, strategic advisor John Berridge, and Drug Shortage Prevention Plan leaders Joe Famulare, Paul D'Eramo, Donna Gulbinski, and Sam Venugopal.

  • ISPE Set To Address Drug Shortages At Annual Meeting

    Drug shortages continue to plague the pharmaceutical industry. According to a GAO report on shortages, dated February 2014, the number of shortages continues to increase in the U.S., as well as around the world. In 2007 there were 154 shortages, 114 new shortages and 40 ongoing from a prior year. In 2012, there were 456 shortages, 195 news ones and 261 ongoing. As of June 30, 2013, there were already 73 new shortages and 288 ongoing.

    The public health importance of these shortages cannot be overemphasized. Shortage situations have included zinc for parenteral nutrition in neonates and premature infants, doxorubicin for ovarian and other cancers, and Propofol for anesthesia.

    Clearly something needs to be done. “ISPE believes efforts to address this complex and multi-faceted problem of drug shortages requires close collaboration and clear communication between the pharma industry and global health authorities,” says Francois Sallans, VP and chief quality officer for Johnson & Johnson, and presenter at the 2014 ISPE-FDA CGMP Conference. “We believe The Drug Shortages Prevention Plan being assembled by ISPE will provide guidance to pharma and global health authorities to manage drug shortages more effectively. But more importantly we are looking into ways for the two groups to manage these shortages more proactively as well. That is an important component that we need to have in place in order to make these shortages rare, but short-lived.”

  • What Can You Learn From The Educational Planning Process Of BIO?

    In my role as the 2015 co-chair of the BIO International’s educational planning committee, I am privy to what goes into creating one of our industry’s largest annual events. As many of you are involved in organizing your own customer educational programs (e.g., The Emerson Exchange) or have been asked to serve on an event planning committee, I thought a behind the scenes look into how BIO goes about the process would be helpful to your efforts. Here are some of the best business practices I have witnessed thus far.

  • Innovation In Clinical Trials: Is It Time To Change The Paradigm?

    “People hate change. This is true in the life sciences industry and everywhere in the world. I think it’s a major, major problem.”

    That statement, by Glen de Vries, president of Medidata, seems to sum up the challenge many have with trying to bring down the cost of clinical trials. To bring down costs we need to implement new, efficient, and available technologies. Unfortunately implementing new technologies involves change, which many people in this industry do not seem to want to embrace.

    Hopefully, that attitude may soon be changing. One of the trends de Vries has seen in the past year is a focus on innovation originating at the executive level. More managers, especially those in the C-suite, are saying we need to figure out how to do things differently.

More From Pharma Contributing Editors


  • QbD: An Effective Roller Compation Process
    QbD: An Effective Roller Compation Process

    A description of the Roller Compaction process and the various process parameters that affect the quality of the roller compacted ribbons. Feed rate, compaction pressure, and roll speed are all discussed.

  • Quality and Manufacturing Complete Control- Keeping Documents on Track
    Quality and Manufacturing Complete Control- Keeping Documents on Track

    Trying to keep track of up-to-date documents and templates can be like chasing down…well you know. But with EMC Documentum Quality and Manufacturing time-consuming reviews and approval efforts can be minimized with centralized control and a unified document repository- all while adhering to GMP compliance and mitigating risks and delays.

  • R&D Submissions Ready- The Mission Control from EMC Documentum
    R&D Submissions Ready- The Mission Control from EMC Documentum

    EMC Documentum Research and Development delivers the control and collaboration needed to sit in the mission control seat. With predefined taxonomies, workflows and templates you can ensure both compliance and up-to-date regulatory submissions.

  • It Might Look Like Just A Box - But It's A Lot More Than That
    It Might Look Like Just A Box - But It's A Lot More Than That

    Envirotainer R&D continuously strives to improve reliability – it is core of all our operations. As a market leader, Envirotainer also takes on the role of driving innovation of existing products and solutions for the future.

  • Cold Chain Open House 2014 Webinar
    Cold Chain Open House 2014 Webinar

    Camille Madelon, Strategy and Business Development Director, states, “The industry needs innovation to stay competitive and relevant in the future – to meet new demands, for example due to changing regulations, emerging markets and new drug segments such as personalized medicine.”

More Videos


  • Federal Equipment Company
    Federal Equipment Company

    For more than 50 years, Federal Equipment Company has been a trusted name in the processing equipment industry. As one of the world’s top suppliers, Federal Equipment is dedicated to providing quality used equipment, outstanding service and competitive prices to meet the needs of the pharmaceutical and related process industries.

  • TASI Group: Bonfiglioli Engineering and Sepha
    TASI Group: Bonfiglioli Engineering and Sepha On-line 100% Leak Testing Machines|Laboratory Leak Testing Machines|Systems for package Integrity control and testing
  • STERIS Corporation
    STERIS Corporation

    STERIS is a global leader in infection prevention, contamination control, surgical and critical care technologies, and more.

  • Envirotainer

    We are a global market leading provider of an air cargo cold chain transportation concept to pharmaceutical companies and their logistics partners. We are unique and the benchmark for global air cargo cold chain management and logistics solutions.






The Information Source for the Pharmaceutical Manufacturing Industry

Welcome to Pharmaceutical Online, the premier sourcing site for the pharmaceutical manufacturing industry, find industry information on critical environment, particle sizing, pharma process control, pharma material handling, tablet production, pharma sterilizing, pharma cleaning, pharma filtration, pharma packaging, pharma inspection, & much more. Use our product showcase, and offline search service to expedite your discovery of new products and services. Our goal is to help buyers, like you, identify and select suppliers.

Pharmaceutical Online is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute. Please take a moment to join our community and discover the benefits of your free membership.

Newsletter Signup
Newsletter Signup
By clicking Sign Me Up, you agree to our Terms and that you have read our Privacy Policy.


Just because the November debut of PharmaExpo is over, doesn’t mean the learning and networking has to stop.  

Learn More


Monitoring Informed Consent (IC): Frequently Asked Questions

February 2, 2015
1pm-2:30pm EST, Online Training

Regulatory Affairs for Biologics – A Compliance Primer

February 4, 2015
1pm-2:30pm EST, Online Training

Surviving a FDA GCP Inspection – Preparation Techniques for Success

February 5, 2015
1pm-2:30pm EST, Online Training

FDA Guidance on Social Media: Questions Answered and Unanswered

February 10, 2015
1pm-2:30pm EST, Online Training

Strategic Clinical Project Management: Principles and Practical Applications

February 11, 2015
1pm-2:30pm EDT, Online Training
More Upcoming Courses


More From Life Science Webinars


  • The Importance Of Automation In Conjunction With Single-Use Systems

    Single-use mixing is an established technology in biopharmaceutical manufacturing operations. The next genesis of this technology is combining the benefits of single-use with the automation historically available only in conventional systems.  The Saltus® platform delivers on the promise of next generation single-use mixing by providing an integrated control platform which uses automation to facilitate increased process robustness for the end-user.

  • How To Adopt A New Pharmaceutical Innovation Paradigm

    Dan Balan, president of Fast Track, discusses the urgent need for pharma to address and revise the innovation paradigm.

  • The Future Of Pharmaceutical Checkweighing

    In his interview at Pack EXPO, Gerald Lisowski, general manager, Mettler-Toledo Hi-Speed, highlights some of the label protection, vision system, and checkweighing solutions entering the pharma and food industries. 

  • The Keys To Packaging Transdermal Patches

    At Pack EXPO, Todd and Todd interviewed Georgia Mohr, marketing director, pharmaceuticals for Bemis Healthcare Packaging, about the various  packaging solutions that exist in the transdermal patch market. 



4th CROWN Congress

January 27 - 29, 2015
Philadelphia, PA

Webinar On How to Develop a Master Validation Plan

January 27, 2015
Mississauga, ON

7th annual Pre-Filled Syringes

January 28 - 29, 2015

19th Annual Drug Delivery Partnerships

January 28 - 30, 2015
Boca Raton, FL
More Events....


Feed Image
RT @PharmTechGroup: Expert from J&J's Janssen discusses global regulatory compliance for product registrations. Free June 11 webcast. http…
3 hours ago

06.11.13 -- Temperature Monitoring Comparisons For The Pharmaceutical Supply Chain
3 hours ago