EDITOR'S DESK

  • Are Drones Feasible In Biopharma?
    Are Drones Feasible In Biopharma?

    Back in March, UPS and autonomous drone technology provider Matternet announced they had collectively begun delivering medical samples via unmanned drones at WakeMed’s flagship hospital and campus near Raleigh, N.C.

The Debate On Standards In Biologics Development Heats Up

Though it’s only natural to expect animated scientific discussion between the FDA and USP which have long been partners-in-science, I found myself caught off-guard by just how firmly the FDA has been putting its foot down and making its thoughts known on the role certain standards — in particular, USP monographs — should (or should not play) in biologics development.

FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?

In this first of what will be a two-part article, USP's Fouad Atouf highlights the challenges presented by the FDA’s newest guidance while remaining optimistic that the large amount of data recommended today will open doors to more efficient development in the (hopefully) near future.

Why We Should Celebrate The FDA’s Biosimilar Comparative Analytics Guidance

Despite the importance of the process the FDA is outlining in the guidance, I’ve surprisingly heard little chatter — positive or negative — about what the agency is now outlining and what this may mean for biosimilars and the biosimilar regulatory paradigm moving forward. Here are a couple of the biggest takeaways to note.

3 Countries To Watch In The MENA Region

Though there is a large handful of countries that, to date, don’t have biosimilar pathways established, a few countries have been slowly gearing up to be leaders in paving the way for biologics and biosimilars. In this article, I’ll discuss the potential of these three markets, as well as the business considerations Challand highlighted for companies considering entering the MENA region.

More From Our Editors

GUEST COLUMNISTS

  • Asia Bioprocessing Capacity Trends: Overall Growth, But Cell Therapy Shortages Loom
    Asia Bioprocessing Capacity Trends: Overall Growth, But Cell Therapy Shortages Loom

    Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually. New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production for major markets, with capacity involving commercial-scale stainless steel and single-use bioreactors.

  • Does A Phase 1 Virtual Biopharma Company Need A cGMP Quality System?
    Does A Phase 1 Virtual Biopharma Company Need A cGMP Quality System?

    Virtual pharmaceutical/biotech companies often receive conflicting advice regarding the need to establish an internal cGMP quality system. Either they’re told “you need an extensive set of cGMP SOPs” or “you don’t need any cGMP SOPs at all.” Which advice is correct?

  • 4 Important Things To Consider Before Developing A Drug Delivery Device
    4 Important Things To Consider Before Developing A Drug Delivery Device

    This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development.

  • 2019 U.S. State Policy Trends Impacting Pharma Manufacturers
    2019 U.S. State Policy Trends Impacting Pharma Manufacturers

    If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.

  • Establishing And Maintaining A Treatment Network For Your Cell And Gene Therapy Product
    Establishing And Maintaining A Treatment Network For Your Cell And Gene Therapy Product

    Delivering cell and gene therapies is an expensive and highly complex process, and there are a number of critical metrics that manufacturers should consider when selecting treatment sites. Subsequent activities — preparing sites to receive and initiate therapy, and managing site training and ongoing certification — can be equally, if not more, challenging.

  • How To Prepare For An FDA Inspection
    How To Prepare For An FDA Inspection

    An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections and will generally result in inspectional observations.

  • 3 Surefire Approaches To SOP Harmonization
    3 Surefire Approaches To SOP Harmonization

    We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

  • How 2 Recent Court Cases Could Impact Follow-On Biologics Strategy
    How 2 Recent Court Cases Could Impact Follow-On Biologics Strategy

    As follow-on biologics litigation expands, and the FDA provides additional information on the approval process for follow-on biologics, industry and observers are gaining clarity on how the Biologics Price Competition and Innovation Act (BPCIA) functions in practice. This article provides insight into two recent developments that will impact strategic and economic considerations for biologics developers.

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BIOPROCESSING WHITE PAPERS

  • Minimizing Sterile Filtration Risk Through Quality By Design

    Steps to ensure products are free from microbial contamination and achieve a sufficient level of risk mitigation against potential bioburden issues for these applications.

  • Biosimilars: Regulatory Trends And Manufacturing Considerations

    Regulatory approval of a biosimilar requires comprehensive knowledge of both the process and the molecule while process development with the end goal in mind will help to achieve a robust manufacturing process.

  • Off-Site Storage Of Biological Specimens And Biologics For Risk Mitigation

    Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment.

  • Industry Trends Changing Sterile Filtration

    To help meet the needs of both large- and small-scale operations, suppliers of sterilizing-grade filters have developed new products and technologies to help meet the needs of today’s biomanufacturing processes. Industry trends toward intensified processing and increased implementation of single-use systems are changing approaches to sterile filtration and bioburden control in biomanufacturing processes.

  • Using A CMO To Streamline Process Characterization

    While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

More Bioprocessing White Papers

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LIFE SCIENCE INDUSTRY EVENTS

Lyophilization - An Introduction to the Scientific Principles August 27 - 27, 2019
1pm-2:30pm EST, Online Training
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell Line August 29, 2019
Time: 11:00 AM Eastern Daylight Time. Duration 1 Hour
BioProcess International September 9 - 12, 2019
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The Top Method Validation Mistakes – And How to Avoid Them September 9 - 9, 2019
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Lyophilization - An Introduction to the Scientific Principles August 27 - 27, 2019
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The Top Method Validation Mistakes – And How to Avoid Them September 9 - 9, 2019
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Pediatric Clinical Trials: Special Considerations and Requirements September 13 - 13, 2019
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How to Write SOPs That are GCP Compliant and Implementable September 17 - 17, 2019
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