EDITOR'S DESK

  • Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway
    Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway

    Though the FDA has taken great efforts in the past year to stand up for biosimilars and establish the BAP, one expert argues the agency can do more to confidently and simply underscore the quality of biosimilar products and to reconsider the need for the additional studies required of biosimilars, especially — but not just limited to — clinical studies.

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?"

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GUEST CONTRIBUTORS

  • Reimagining Quality Operations In The Life Sciences
    Reimagining Quality Operations In The Life Sciences

    This is the third of three articles focusing on an effort to address what appear to be systemic issues across quality departments, informed by a multinational group comprising chief quality officers (CQOs) from pharma, device, animal health, and consumer goods companies. It will examine how to achieve cross-functional ownership of quality and the efforts of the CQO team to build quality for the 21st century, including exploring the creation of formal degree programs in quality.

  • How Technology Will Reshape The Future Of Aseptic Processing
    How Technology Will Reshape The Future Of Aseptic Processing

    Using new and existing technologies to improve aseptic processing manufacturing may provide the need and opportunity for new approaches to process control and monitoring. In some cases, improvements to these approaches will require the use of existing technology. In other cases, they will be required to support the implementation and use of new technology.

  • How To Write An Effective Validation Master Plan
    How To Write An Effective Validation Master Plan

    A validation master plan (VMP) outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. Master plans are written to assist an organization with validation strategies or to provide control over a specific process.

  • Overcoming The Unique Filling Challenges Of Autologous Therapies

    Autologous (patient-derived) therapies represent unique challenges to processing. One-patient, single-batch is a radical change from the scale our industry is accustomed to. At this level the filling is more analogous to limited Phase 1 clinical trial materials or even preclinical applications. The logistics and required compliance of manufacturing these personalized therapies is drastically different and presents a combinatorial explosive problem. One aspect of this process where traditional methods fall apart is filling of these therapies.

  • What Is Skinny Labeling — And Will It Work For Biosimilars?

    “Skinny labeling” refers to the practice of follow-on drug manufacturers seeking approval for some but not all the indications for which the branded drug has been approved. In the small molecule drug world, it has been a successful strategy for generic drug makers to get around the brand’s follow-on “new use” patents that keep the brand from falling off the “patent cliff” long after the expiration of the original patents. This strategy is starting to be used in the biosimilar realm.

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BIOPROCESSING WHITE PAPERS

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INDUSTRY INSIGHTS

  • Are Today’s Processes Efficient Enough For The Future Of Vaccine And Viral Vector Production?
    Are Today’s Processes Efficient Enough For The Future Of Vaccine And Viral Vector Production?

    By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.

  • Take C&GT Supply Challenges By The Horn
    Take C&GT Supply Challenges By The Horn

    While traditional biotechnology focuses on material inventory, cell therapy products must account for the entirety of a patient’s journey in order to develop a robust supply strategy. These concepts will be discussed in much more detail at the 2019 PDA Cell and Gene Therapy Conference. The conference will provide insight on process development, supply chain, validation, new advances in gene therapy, the patient experience and more!

  • 3 Steps To Determine Need For Performing A Shipping Lane Qualification
    3 Steps To Determine Need For Performing A Shipping Lane Qualification

    Materials moving through the Pharmaceutical Supply Chain encounter many threats which could negatively impact product integrity. Learn how perform various risk assessments to adequately determine the level of control required to ensure the safe transport of products.

  • Vendor Views On Bioprocess Innovation
    Vendor Views On Bioprocess Innovation

    Two industry experts explain how vendors contribute to improving and enhancing bioprocess operations.They give insight on the future of single-use technologies and continuous bioprocessing in this ever changing market.

  • Are You Prepared For The Complexity Of Pediatric Drug Development?
    Are You Prepared For The Complexity Of Pediatric Drug Development?

    Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays.

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LIFE SCIENCE INDUSTRY EVENTS

PAP 2019 March 5 - 6, 2019
Baltimore, MD
IVT's Statistics in Validation March 6 - 7, 2019
Philadelphia, PA
Medical Device Validation Week March 12 - 14, 2019
Minneapolis, MN
Life Sciences Accounting and Reporting Congress March 20 - 22, 2019
Philadelphia, PA
15th Annual Pharma Forum 2019 March 24 - 27, 2019
New York, NY
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TRAINING COURSES

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