EDITOR'S DESK

  • Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations
    Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations

    I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.

Samsung Bioepis: Applying The "Hunger" For Biosimilars To Novel Drugs

Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.

New U.S And Canadian Facilities Boosting Biologics Capacity

Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.

Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”

There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"

2018 Outlook: Biosimilar Trends To Watch

Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.

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GUEST CONTRIBUTORS

  • Does Quality Even Matter? 10 Things Quality Departments Should Stop Doing Now
    Does Quality Even Matter? 10 Things Quality Departments Should Stop Doing Now

    Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success. What would cause business partners to look at quality in such a way?

  • Nontraditional Design Concepts To Accelerate CAR T Processing
    Nontraditional Design Concepts To Accelerate CAR T Processing

    Cell therapies, in particular, chimeric antigen receptor modified T cells (CAR-T), are showing enormous therapeutic promise, with cancer remission rates over 80 percent.1 This alone is forcing cell therapy manufacturing companies to develop strategies to build and scale up production at levels never contemplated before.

  • 4 Strategies To Prevent Manufacture And Distribution Of Substandard Medications
    4 Strategies To Prevent Manufacture And Distribution Of Substandard Medications

    Counterfeit medications aren’t the only prescription drug-related threat to public health. If a legitimate product is not manufactured according to quality standards or becomes degraded as it travels through its supply chain, it can be ineffective at best or deadly at worst. However, separating the issues of counterfeit and substandard medications is a difficult proposition.

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BIOPROCESSING WHITE PAPERS

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INDUSTRY INSIGHTS

  • Making Next Generation Manufacturing Work In Bioprocessing
    Making Next Generation Manufacturing Work In Bioprocessing

    When it comes to downstream bioprocessing, we already have many of the technologies we require – we only need to focus on adapting them.

  • What Are Exosomes?
    What Are Exosomes?

    Gain an understanding of  exosomes which are recently attracting attentions of researchers as new mediators of cell-cell communication transporting biomolecules such as lipids, proteins, and RNAs in vivo.

  • Different Environments Where Bacterial Endotoxins Can Be Found
    Different Environments Where Bacterial Endotoxins Can Be Found

    They are many environments that may be contaminated with bacterial endotoxins, since Gram-negative bacteria are characterized by their great level of ubiquity.

  • Dancing In The Bioprocessing Ballroom: Voices Of Experience
    Dancing In The Bioprocessing Ballroom: Voices Of Experience

    Single-use technology is well-established, and has made its way into commercial licensed facilities, but there is more innovation in this field which will further enhance its versatility into new markets and technologies. The closed-system ballroom manufacturing approach will enable biomanufacturers to take full advantage of the flexibility offered by single-use systems, while driving out risk and is particularly suitable for applications that require multiple or rapid change-overs, and therapies with small scale production.  

  • Perfecting Perfusion In Bioprocessing
    Perfecting Perfusion In Bioprocessing

    As the need for smaller plants, flexible manufacturing and competition intensifies in the biopharma industry, so does the need for intensified processes

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LIFE SCIENCE INDUSTRY EVENTS

Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
6th Annual Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
Patients Registries & Real World Evidence Summit January 30 - 31, 2019
Miami, FL
PAP 2019 March 5 - 6, 2019
Baltimore, MD
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TRAINING COURSES

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