FROM THE EDITOR

Building Cancer Assassins: Kite Pharma Talks CAR T-Cell Therapy

Improvements in molecular biology and the understanding of immunology have generated compelling results in recent clinical trials for CAR T-cell therapies. As a result, interest in this area has increased tremendously. I recently spoke with Dr. Marc Better, VP of product sciences at Kite Pharma, about what challenges and opportunities await any company entering this growing market.

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BIOPROCESS INSIGHT

  • How To Reduce The Complexity And Mitigate Risk In Qualifying Active Temperature Controlled Systems
    How To Reduce The Complexity And Mitigate Risk In Qualifying Active Temperature Controlled Systems

    Every shipment of life science products is precious cargo, not only to the shipper, but to the patient at the end of the chain. That transportation process must be strictly qualified to ensure that the product is not lost to damage or spoilage. Even with the most careful planning, losses may occur due to human error.

  • Modular Facility Design: A Cost-Effective Option In The Post-Blockbuster Drug Era
    Modular Facility Design: A Cost-Effective Option In The Post-Blockbuster Drug Era

    The pharmaceutical industry has undergone a sea of change in recent years as manufacturers have adapted to the end of the era of large-volume production of mass-market blockbuster drugs. With firms now focusing in on subpopulations of patients, there is a need for lean, adaptable facilities that can switch quickly between multiple products in multiple formats. Modular facilities can meet this need. While not a panacea, for the right project characteristics, ‘Modularity in Design’ can deliver significant and quantifiable long-term value.

  • Serialization: The Key To Success For Pharmaceutical Manufacturers
    Serialization: The Key To Success For Pharmaceutical Manufacturers

    This white paper is an abridged version of this paper on the serialization of pharmaceuticals. Download it to learn more about the benefits of recent developments in control technology, handling large volumes of data, transparency and tracking, how future-oriented solutions can help combat evolving rules and regulations, and more.

  • A cGMP-Ready Purification Process For Adenovirus Purification
    A cGMP-Ready Purification Process For Adenovirus Purification

    Large-scale downstream processing of viruses for clinical applications poses challenges different from those of many biotherapeutics. 

  • Improve Your Facility Monitoring System To Comply With Regulatory Requirements
    Improve Your Facility Monitoring System To Comply With Regulatory Requirements

    A facility monitoring system (FMS) is a process monitoring tool that collects data from sensors such as optical particle counters, differential pressure sensors, and temperature probes in realtime. Acronyms are independent monitoring system (IMS) or environmental monitoring system (EMS). Software presents that data as information; real-time alarms notify facility operators of alert limits to enable an immediate response to an unwanted event or excursion. Reports and trend graphs can be produced.

  • Rapid Development And Scale Up Of A Biosimilar
    Rapid Development And Scale Up Of A Biosimilar

    Increasing and competitive market of Biosimilars requires a rapid platform from cell line development to process development and scale-up to manufacturing.

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BIOPROCESS CONTRIBUTING EDITORS

  • Could 96 Percent FDA Drug Approval Rate Harm Biosimilar Market?
    Could 96 Percent FDA Drug Approval Rate Harm Biosimilar Market?

    Last week, Matthew Herper of Forbes published an eye-opening article providing a closer look at FDA approvals in recent years, coming to the conclusion that the industry is facing what could be a dangerously high approval rate for new drugs. But how could high approval rates be a bad thing?

  • FDA Releases Long Awaited Guidance On Biosimilars Naming
    FDA Releases Long Awaited Guidance On Biosimilars Naming

    After months of debate between reference product makers and generic manufacturers, the FDA released its long-awaited guidance proposing a naming strategy for biosimilars.

  • Could AbbVie Hurt Itself With Biosimilar Labeling Demands?
    Could AbbVie Hurt Itself With Biosimilar Labeling Demands?

    In May, the FDA changed its stance on several key points of its draft version of the “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.” In accordance with these changes, any biosimilar licensed under the PHS Act § 351 (k) no longer needs to contain a statement on its label indicating that it is a biosimilar.

  • Do Biosimilars Fit Into The Innovation Paradigm?
    Do Biosimilars Fit Into The Innovation Paradigm?

    As an industry, pharma is inundated with the term “innovation.” Patent laws and data exclusivity negotiations like the stalled Trans-Pacific Partnership (TPP) are centered around protecting innovation. Bayer recently established a team dedicated solely to pursuing innovation — though board member Kemal Malik was quick to tell Life Science Leader magazine that most people in the industry “have a tough time explaining [innovation].”

  • Could Birth Of “Big Generic” Be Foreshadowing “Big Biosimilar?”
    Could Birth Of “Big Generic” Be Foreshadowing “Big Biosimilar?”

    The past few weeks, the generics market has seen several players jump ship and one company grow significantly — and to some, alarmingly — larger.

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