EDITOR'S DESK

  • Pfenex’s New CEO Sizes Up Biosimilar Industry’s Future
    Pfenex’s New CEO Sizes Up Biosimilar Industry’s Future

    Newly-appointed Pfenex CEO, Eef Schimmelpennink, faces the challenge of determining how to adapt Pfenex to a constantly changing future. Though it's still very early in his tenure, Schimmelpennink highlights some areas he will keep in mind as he steers Pfenex's future biosimilars onto the market.  

The Evolving Landscape Of Biosimilar Risk Management Programs

In a presentation at the 2017 World Biosimilars Congress, Asif Mahmood, disease area safety and strategy lead at Pfizer, shed some light on global risk management strategies and the challenges of launching these programs.

The Evolution Of Russia’s Biosimilar Regulatory Pathway

In a recent article, I discussed the market opportunities and reimbursement system in Russia. But in addition to this snapshot of the market, my conversation with BIOCAD's Roman Ivanov highlighted how the Russian biosimilar regulatory system was established, as well as the challenges BIOCAD has faced during it evolution.

Russia’s Biosimilar Market At A Glance

After my discussion with BIOCAD's Roman Ivanov, it’s clear the Russian biosimilar market is a prime example of the positive impact biosimilars can have on a nation. However, Russia's biosimilar market has evolved quite differently than those of the EU and U.S.

Plant-Based Biosimilar Development Takes Root In Brazil

In June 2017, Canadian company PlantForm announced it was beginning construction for a pilot biologics and biosimilar manufacturing facility in Brazil. Given Brazil’s ongoing efforts to establish a local biotechnology industry, I reached out to learn more about PlantForm’s progress in navigating the regulatory landscape to bring its biosimilars closer to market.

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GUEST CONTRIBUTORS

  • Are You Prepared For The EU’s FMD Safety Features Delegated Regulation?
    Are You Prepared For The EU’s FMD Safety Features Delegated Regulation?

    The European Union’s (EU) Falsified Medicines (FMD) Directive 2011/62/EU amends Directive 2001/83/EC to safeguard public health by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines. It also introduces new rules to more rigorously regulate the supply chain.

  • Validation Of Visual Inspection As An Analytical Method For Cleaning Validation
    Validation Of Visual Inspection As An Analytical Method For Cleaning Validation

    It has never been clear whether visual inspection is reliable since it has never actually been validated. If it can be validated, then the use of this technique for release of equipment would be justified and might even be used in place of traditional swab methods, which take substantial amounts of time and resources to develop, validate, and perform.

  • Using Trending As A Tool For Risk-Based Thinking
    Using Trending As A Tool For Risk-Based Thinking

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. While the concept of risk management is not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.

  • Can New York City Lead In Life Sciences?

    New York City has long aspired to become a life sciences hub, but while the city seems to have all the elements necessary to foster such industry growth, it has continually fallen short of this goal. New York currently ranks a distant third behind both Greater Boston and the San Francisco Bay Area, and there’s some work to do if it hopes to catch up.

  • Can Biosimilars Increase The Profitability Of Generics Manufacturers?

    Generic drug prices are falling. For confirmation, look no further than the recent earnings reports from generic manufacturers and pharmaceutical wholesalers whose profits from distributing generic pharmaceuticals are also declining.

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BIOPROCESSING WHITE PAPERS

  • What Is Multivariate Analysis?

    Most of the problems in the world are multivariate in nature - meaning that there are many variables that contribute to them. We cannot simply use the season of the year to predict the weather, as many other variables are part of the relationship to weather.

  • Speed Up The Pace Of Chemical Research And Development

    Today’s chemical development labs are busy places that create fascinating new chemicals, new formulations and new products that boost the bottom line. But are these labs as efficient as they could be?

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INDUSTRY INSIGHTS

  • Biosimilar Developers Must Scale Mountains of Data
    Biosimilar Developers Must Scale Mountains of Data

    The U.S. FDA approved Sandoz’s filgrastim product, Zarxio, a biosimilar of Amgen’s Neupogen. This was a big step for the Agency, and one some feel was long in coming. The same product was approved for marketing in Europe six years earlier (under the name Zarzio).

  • Bioburden Sources You Might Have Missed
    Bioburden Sources You Might Have Missed

    A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.

  • Anticipating The Formulation Challenges Of Complex Molecules
    Anticipating The Formulation Challenges Of Complex Molecules

    Due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.

  • Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off
    Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off

    With biologics filling the pipelines of life sciences companies more than ever, the biopharmaceutical industry needs to rethink its view of quality. Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research.

  • Cost And Impact Of A Bioburden Incident
    Cost And Impact Of A Bioburden Incident

    Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks.

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LIFE SCIENCE INDUSTRY EVENTS

15th Annual Global Forum September 25 - 29, 2017
Chicago, IL
The HireLifeScience.com Career Fair 2017 September 26, 2017
Edison, NJ
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner September 28, 2017
1pm-2:30pm EDT, Online Training
Organizational Strategies for Reducing Human Error in GMP Environments October 3, 2017
1:00 - 2:30 PM EDT, Online training
More Industry Events