• Pfizer’s Key Questions For CMO Innovation
    Pfizer’s Key Questions For CMO Innovation

    As it turns out, Bernie Huyghe of Pfizer has a flair for interrogative statements. This has served him well as a leader in the biopharmaceuticals and vaccines outsourcing group at the company. It also helped lead a room full of bio/pharma and CMO professionals through the subject of innovation in the external development and supply chain.

Pharma’s Super Heroes Of Innovation

The supply chain is Pharma’s new super hero of innovation. But like any super hero, drug development and manufacturing providers struggle with a dual identity. One is conservative, steadfast, an order-taker. The other – the one Pharma wants today – breaks out into innovation and ingenious solutions. Can CMOs serve Metropolis in both capacities? We’ll find some answers in this sneak preview.

Top (Secret) Quality Concerns For Selecting CMOs: How Important Are Records?

Five experts go undercover to prioritize a secret top-ten list of quality topics for Pharma and Bio sponsors selecting contract development and manufacturing organizations (CMOs). After weeks of discussion, they select a venue full of drug industry sponsors and service providers to unveil their work. They aren’t aware, though, that the audience will have its own stab at the list.

The Price At My CMO Isn’t Right … But How Do I Know?

“What we’re doing up here is never done – focusing on that one input in public. Instead of focusing on money, you talk openly about ‘value.' Well, what is that? Or it’s all about ‘relationships.’ The industry talks partnership in public, but behind closed doors, aren’t prices and costs closing or breaking outsourcing business deals?”

Riding With The Drug “Serializers” Of Pharma

A recent article with GSK mentioned the assistance Pharma is receiving from external serialization vendors and partners. Like in Wild West movies, the initial decision to bring in these benevolent gunslingers — I call them serializers — is difficult. Unlike the movies, though, there’s no moral equivalence: Few pharmaceutical companies — or packaging service providers — will achieve timely serialization compliance without this outside help.

More From Our Editors


  • A Risk-Based Approach To Environmental Monitoring & Control For Pharmaceutical Distribution
    A Risk-Based Approach To Environmental Monitoring & Control For Pharmaceutical Distribution

    Over the past few decades, many companies have spent time and capital investment in assessing and mitigating risk factors across the extended supply chain. However, even for those companies that have designed and implemented state-of-the-art operational supply and logistics networks, there is always risk that products may be impacted by variations in temperature, humidity, or other deviations from ideal conditions at any stage across the chain of custody.

  • Single-Use Continuous Manufacturing: The New Paradigm In Biopharmaceutical Processing
    Single-Use Continuous Manufacturing: The New Paradigm In Biopharmaceutical Processing

    Two significant trends in biopharmaceutical production are coming together. For years, single-use systems have been gaining traction as a way to make processing of biotherapies more efficient. More recently, the industry has also been eyeing continuous manufacturing options to replace traditional “batch” processing methods — again, with the goal of obtaining greater efficiencies.

  • Quality Systems 101: Basic Concepts & Considerations
    Quality Systems 101: Basic Concepts & Considerations

    Whether you are a life science startup with a brick-and-mortar office or working as a virtual company, at some point the question comes up: Do we need a quality system? Or perhaps your question is, What is a quality system?

  • 6 Tips For Better Time Management In Pharmaceutical Operations

    We all want to maximize the productive use of our time, correct? Over the span of my pharmaceutical industry career, I have been fascinated with this topic. It started when one of my supervisors in supply chain gave copies of The 7 Habits of Highly Effective People to me and the rest of his staff, which became one of many books on time management I have read.

  • What Recent FDA Enforcement Actions In The EU Mean For FDA/EMA Cooperation

    FDA and the EU have taken serious enforcement actions against firms in the other’s geographic jurisdiction during the calendar year 2016. In the preceding article, we looked at European inspectorate actions against sites in the U.S. Issues identified as problematic included deficiencies in aseptic processing of parenteral drugs, data integrity concerns, lack of controls to prevent cross-contamination, and failure to adequately address observations from previous inspections. FDA had inspected each of the three facilities within the past year.

More From Guest Contributors


  • Thermo Fisher Integrates Checkweighing, Marking And Verification Thermo Fisher Scientific achieved its goal to eliminate line splitting, save space and, ultimately, cut costs for pharmaceutical manufacturers. They developed an integrated solution for checkweighing, marking and verification functions.
  • Alternative Design Of PTFE Liner Represents An Improvement In Hose Construction PTFE (polytetrafluoroethylene) was discovered in 1938. While the bore of the PTFE liner is effectively smooth, the outside surface is convoluted to provide ‘hoop strength,’ so the liner is self-strengthened and does not need to be bonded with an adhesive to the outside braid or rubber layers. By Rod Anderson, Managing Director, Aflex Hose Ltd.
More Pharma Onine White Papers


  • Solutions to Today’s Biomanufacturing Challenges
    Solutions to Today’s Biomanufacturing Challenges

    With more complex molecules in development, changing capacity needs, uncertain forecasts and increased competition, the market demands flexibility and innovative approaches to address today’s new challenges.

  • The FDA Says You Are Responsible . . . But Do You Know You Are?
    The FDA Says You Are Responsible . . . But Do You Know You Are?

    An FDA warning letter was recently issued to a contract testing lab that contained a clear warning.

  • USP Chapter 1207 Package Integrity Evaluation – Sterile Products

    Selecting primary packages for assuring the integrity of a sterile package can be much more complicated than many drug formulators realize. A new USP chapter was released recently to provide guidance on the integrity of packaging intended for sterile products. This article provides an overview of each of the sections in the new 1207 chapter that became live on August 1, 2016.

  • Fighting Cancer With Targeted Drugs
    Fighting Cancer With Targeted Drugs

    “Cancer” is a collective term that describes numerous different and malignant new tissue formations.

  • Container Closure Integrity Testing Of Complex Drug Delivery Systems
    Container Closure Integrity Testing Of Complex Drug Delivery Systems

    New injection-delivery systems have introduced new challenges to package validation and product development, particularly for container closures. Each component coming in contact with the critical product path must be validated to provide a reliable sterile barrier. Planning for container-closure integrity testing of the delivery system is crucial.

More Industry Insights


PMRG 2016 Institute (Pharmaceutical Market Research Group) October 24 - 26, 2016
Cherry Hill, NJ
7th International Conference on Bioinformatics October 24 - 25, 2016
Holiday Inn Rome Aurelia, Via Aurelia, Rome,Italy
ISPE Europe Conference on BIOTECHNOLOGY October 24 - 25, 2016
10th Digital Pharma East October 24 - 27, 2016
Philadelphia, PA
More Industry Events