FROM THE EDITOR

Scale-Up Of Autologous Cell Therapies Realized Through Technological Collaboration

The autologous cell therapy market is experiencing tremendous growth, but under the current system for manufacturing these products, companies struggle to get a return on their investments. However, a recent partnership between Octane and Lonza may finally offer a cost-effective solution to scale-up that could give companies new hope for commercialization.

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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 Harper 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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