EDITOR'S DESK

  • A Second Reformation: Returning Biosimilar Regulations To Scientific Roots
    A Second Reformation: Returning Biosimilar Regulations To Scientific Roots

    In light of BioApproval's Chris Webster’s recent publication and future presentation at the upcoming DIA Biosimilars conference, I spoke with him to learn more about the "Confirmation of Sufficient Likeness" approach and the scientific evidence that has informed this proposed biosimilar regulatory paradigm shift away from Totality of Evidence.

Cutting Through The Noise: The Bright Side Of Biosimilar Progress

Because negative news and opinions seem to create greater waves, I thought I would take stock of the positive news that may not have come over your desks or (more realistically) cellphones in the past few weeks. While it’s easy to get bogged down by negative speculation, there’s progress being made and companies and experts fighting daily to keep this industry moving forward, even if it feels glacial.

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.

More From Our Editors

GUEST COLUMNISTS

  • Examining FDA’s New Patient Labeling Draft Guidance
    Examining FDA’s New Patient Labeling Draft Guidance

    In accordance with the increasing emphasis on human factors as it applies to medical products and their associated written materials, the FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.

  • Pharmaceutical Transport Validation — Where To Begin?
    Pharmaceutical Transport Validation — Where To Begin?

    This article provides a road map for transport validation, which is used to qualify packaging for the entire product supply chain. When transport validation is done incompletely, poorly, or not at all, it can result in off-label drugs that are potentially harmful to patients.

  • Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”
    Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”

    With all the attention on the costs of pharmaceutical products, there is an upcoming regulatory “dead zone” that will potentially delay market entry of certain insulin products, adversely impacting insulin prices for consumers and payors. A recent Senate bill has been proposed to address this regulatory anomaly. Industry players should monitor this bill and other efforts to address the insulin dead zone, given how critical this product is to so many people.

  • FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018
    FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018

    In this two-part article, FDA Supervisory Consumer Safety Officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 Program Director Art Czabaniuk, and OPQO Division 3 Investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. Part 1 unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.

  • Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?
    Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?

    Are the methods used for developing the current generation of biopharmaceuticals, monoclonal antibodies, hormone replacements, etc., applicable to the next generation of Cellular and gene therapies?

  • Project Execution Models For Biopharmaceutical Facilities
    Project Execution Models For Biopharmaceutical Facilities

    Project execution and project management are probably two of the topics that are most written about but least understood by the biopharmaceutical industry. This article is not about the theory of management, but it is a primer on approaches to project execution, some of which may assist the reader in understanding their path of least risk.

  • Is Your Personnel Hygiene Plan Up To Date?
    Is Your Personnel Hygiene Plan Up To Date?

    Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.

  • Negotiating Quality Technical Agreements: Strategies for Non-Quality Professionals
    Negotiating Quality Technical Agreements: Strategies for Non-Quality Professionals

    Of the four critical documents that must be negotiated and executed by both sponsor and CDMO (NDA, quotation, MSA/SA, and QTA), the QTA is often the least-prioritized by the procurement team. Yet, in practice, the QTA will be the most useful for development- and clinical-stage companies, because it provides a framework for operations and a road map for building quality systems.

More From Our Guest Columnists

BIOPROCESSING WHITE PAPERS

  • Demystifying Extractables Testing
    Demystifying Extractables Testing

    It is critical anyone utilizing single-use technology understands the differences between the various guidances available for extractables analysis and which testing approaches are most suited to the study goals.

More Bioprocessing White Papers

BIOPROCESS ONLINE CONTENT COLLECTIONS

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Download this free collection of articles and learn how to let go of legacy aseptic filling line equipment, seven common filling blunders and how to avoid them, nontraditional design concepts for CAR T processing, what to do when your isolator is taking too long to de-gas. Herman and Erich Bozenhardt bring a collective 54 years of bioprocess facility design and production experience to the pages of this comprehensive ebook.

LIFE SCIENCE INDUSTRY EVENTS

How to Write SOPs That are GCP Compliant and Implementable September 17 - 17, 2019
1pm-2:30pm EDT, Online Training
Root Cause Analysis & CAPA Identification: A Step-by-Step Guide for Manufacturers September 24 - 24, 2019
1pm-2:30pm EDT, Online Training
Smarter Development Of Chromatography Processes September 24, 2019
Time: 11:00 AM Eastern Daylight Time. Duration: 1 hour
Stability Programs – Key Factors in Meeting FDA/ICH Expectations September 26 - 26, 2019
1pm-2:30pm EDT, Online Training
More Industry Events

TRAINING COURSES

How to Write SOPs That are GCP Compliant and Implementable September 17 - 17, 2019
1pm-2:30pm EDT, Online Training
Root Cause Analysis & CAPA Identification: A Step-by-Step Guide for Manufacturers September 24 - 24, 2019
1pm-2:30pm EDT, Online Training
Stability Programs – Key Factors in Meeting FDA/ICH Expectations September 26 - 26, 2019
1pm-2:30pm EDT, Online Training
Sterility Failure Investigations – A Step-by-Step Process for Success September 30 - 30, 2019
1pm-2:30pm EDT, Online Training
More Upcoming Courses