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

  • Recovery Studies: Common Issues & Using Statistical Tools To Understand The Data
    Recovery Studies: Common Issues & Using Statistical Tools To Understand The Data

    This article is the first in a series of articles that will explore some of the typical issues that may be encountered during recovery studies and show how the use of statistical tools for assessing the recovery data can provide greater insight into the results and enable data-driven decisions concerning recovery studies. In this installment, we will look at three case studies.

  • FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis
    FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis

    In Part 1 of 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 presented #10 through #6 of the top drug GMP inspection citations for FY2018 and provide insight into the observations. This part counts down citations #5 through #1.

  • Think A Quality Culture Doesn’t Affect Your Bottom Line? Think Again
    Think A Quality Culture Doesn’t Affect Your Bottom Line? Think Again

    Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen. News of a pharmaceutical company receiving an FDA Complete Response Letter and Form 483 — citing data manipulation and breaches — drove this point home recently. Based on the FDA observations made in this case, there is clear evidence that components of a voluntary quality assurance (VQA) culture were missing.

  • Does Blockchain Make Sense For The Cell & Gene Therapy Supply Chain?
    Does Blockchain Make Sense For The Cell & Gene Therapy Supply Chain?

    Understanding the impact and requirements for a clearly defined supply chain strategy and implementing this into the complex environment of cell and gene therapies is not a simple task. It requires dedication and participation from all the stakeholders across the development-to-delivery life cycle. All the details need to be defined, simulation models developed, and risk assessed — and remediation plans put in place. 

  • 5 Barriers To Blockchain Adoption In The Rx Supply Chain — And How To Overcome Them
    5 Barriers To Blockchain Adoption In The Rx Supply Chain — And How To Overcome Them

    Blockchain has already started to find fit-for-purpose use cases in the pharmaceutical industry. Some of the largest pharma companies in the world are now conducting pilots and are expected to move towards production cases in the coming year. But for blockchain to succeed, several remaining obstacles must still be overcome.

  • 7 Speed Bumps To Avoid When Outsourcing Clinical Supply Manufacturing
    7 Speed Bumps To Avoid When Outsourcing Clinical Supply Manufacturing

    Any company with successful Phase 1 study data must ensure sufficient and consistent supply of drug product for possible Phase 2 and Phase 3 trials. For this reason, Phase 1 companies planning to outsource manufacturing of their clinical supply should take some essential steps early in the clinical manufacturing campaign to assure a timely and reliable supply of material throughout their clinical trials.

  • What Celgene Corp. v. Peter Means For Biosimilar Developers
    What Celgene Corp. v. Peter Means For Biosimilar Developers

    A recent decision by the U.S. Court of Appeals for the Federal Circuit has indicated that pharmaceutical makers with patent protection are unlikely to receive any compensation from the government for the loss of their patents during inter partes review (IPR) decisions by the Patent Trial and Appeal Board (PTAB).

  • 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.

More From Our Guest Columnists

BIOPROCESSING WHITE PAPERS

  • Role Of Cell Based Potency Assay In Functional Characterization Of Therapeutic Monoclonal Antibodies (mAbs)
    Role Of Cell Based Potency Assay In Functional Characterization Of Therapeutic Monoclonal Antibodies (mAbs)

    Characterization of an originator monoclonal antibody (mAb), or comparability study between originator mAb and biosimilar candidate mAb, are challenging due to the highly complex and variable structure of monoclonal antibodies. The characterization of therapeutic monoclonal antibodies should include a wide range of analytical techniques; as well as binding and cell-based potency assays in order to reflect the main mechanism of action and effector function of the mAb of interest.

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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.

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LIFE SCIENCE INDUSTRY EVENTS

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
Sterility Failure Investigations – A Step-by-Step Process for Success September 30 - 30, 2019
1pm-2:30pm EDT, Online Training
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TRAINING COURSES

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
Clinical Research Project Management - 7 Breakthrough Behaviors For Success October 3 - 3, 2019
1pm-2:30pm EDT, Online Training
More Upcoming Courses