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.

More From Our Editors

GUEST CONTRIBUTORS

  • Fault Tree Analysis: Uncovering The Root Causes Of More Complex Problems
    Fault Tree Analysis: Uncovering The Root Causes Of More Complex Problems

    Part 3 of Identifying And Resolving Errors, Defects, And Problems Within Your Organization — a five-part series on operationalizing proper improvement techniques.

  • Establishing A Critical Supply Chain For Autologous Cell And Gene Therapies
    Establishing A Critical Supply Chain For Autologous Cell And Gene Therapies

    With the recent breakthroughs in cell and gene therapy, there is increased emphasis on the design and implementation of different supply chain models to support the movement of materials and drug product across the chain of care. Unlike more traditional supply chains, many of these therapies have unpredictable sources and manufacturing and infusion locations. The most extreme example is loosely referred to as the “vein-to-vein” supply chain — particularly for autologous therapies.

  • Help! My Isolator Is Taking Too Long To Degas — What Should I Do?
    Help! My Isolator Is Taking Too Long To Degas — What Should I Do?

    Probably one of the most significant developments in sterilization and aseptic practices in the pharmaceutical business is that of vaporized hydrogen peroxide (VHP) as a contact or “cold” sterilizing agent. The use of VHP in contained environments has allowed us to decontaminate working spaces, equipment, and materials and has led to the development of the reliable isolator.

  • How Will Trump’s New FTC/DOJ Reporting Requirements Impact Biosimilars?

    This article summarizes the key provisions of the new law and discusses its limitations. I then look at the FTC’s practice in evaluating “reverse payment” settlements in Hatch-Waxman litigations and discuss why similar antitrust analyses of biosimilar settlements will likely be more complex.

  • Health-Based Exposure Limits: How Do The EMA’s Q&As Compare With New And Forthcoming ASTM Standards?

    The EMA Q&As and their updates mark an important turning point in the pharmaceutical industry regarding cleaning validation and quality risk management. The new ASTM standards will provide guidance to the industry on the appropriate development of health based exposure limits, for the implementation of science- and risk-based approaches to cleaning validation, and on the use of statistical techniques for measuring the risk in cleaning and assessing the effectiveness of cleaning processes.

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BIOPROCESSING WHITE PAPERS

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Choosing Your Single-Use Technology Supplier
    Choosing Your Single-Use Technology Supplier

    To be credible, a partner needs to be able to provide technical and regulatory insight, understand your processing needs, be experienced in facility design, and provide advanced operator training.

  • The Future Is “Cloudy” For Data Integrity In Life Sciences
    The Future Is “Cloudy” For Data Integrity In Life Sciences

    Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.

  • How Your LIMS Can Help Reduce The QC Burden In Bioanalysis
    How Your LIMS Can Help Reduce The QC Burden In Bioanalysis

    The quality of your bioanalytical process will determine the quality of your study and with the right solution, the entire process can flow with a seamless assurance.

  • Getting to First-in-Human Clinical Trials: A Make-Or-Break Milestone For Small Biopharmas
    Getting to First-in-Human Clinical Trials: A Make-Or-Break Milestone For Small Biopharmas

    Whether biopharmaceutical companies have one candidate or 100, the directive is clear: moving quickly into FIH testing is essential. But, how?

  • 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.

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

Annual Cardiologists Meeting 2018 November 26 - 27, 2018
Madrid CIty
Blockchain Technology for the Life Sciences: A Comprehensive Primer November 27 - 27, 2018
1pm-2:30pm EST, Online Training
Compliant Patient Support Programs Summit November 28 - 29, 2018
Philadelphia, PA
Clinical Trial Legal and Contracting Forum December 4 - 5, 2018
Philadelphia, PA
Supporting the Patient Experience for Quality Care December 4 - 5, 2018
Philadelphia, PA
More Industry Events

TRAINING COURSES

Blockchain Technology for the Life Sciences: A Comprehensive Primer November 27 - 27, 2018
1pm-2:30pm EST, Online Training
Adverse Event Reporting: Avoiding Common Pitfalls December 11 - 11, 2018
1pm-2:30pm EST, Online Training
More Upcoming Courses