• EDGE Confocal Imaging Technology
    EDGE Confocal Imaging Technology

    Increasingly, scientists are being challenged to study more biologically-relevant model systems, and this often means imaging thick, demanding 3D samples that may also be alive. Read how IRIS and EDGE confocal imaging can offer high contrast imaging of thicker samples.

  • Improving Cell Image Analysis Workflows Through Machine Learning
    Improving Cell Image Analysis Workflows Through Machine Learning

    Artificial intelligence (AI) provides exciting opportunities for fast, accurate, and unbiased cell image analysis. Read this guide to machine learning in high content analysis and see the benefits AI can bring to your automated cell imaging.

  • FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics
    FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics

    While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.

  • A Delicate Balance: Patent Exclusivity, Innovation, And Competition
    A Delicate Balance: Patent Exclusivity, Innovation, And Competition

    Overall, arguments calling into question the value of biologics competition tie into what I think is an even more important question worth asking in this country: What global responsibility does the U.S., as the largest pharmaceutical market, have in terms of promoting greater access to medicines?

  • Scaling A mAb Production Process To A Single-Use Platform
    Scaling A mAb Production Process To A Single-Use Platform

    The transfer of a monoclonal antibody production process between scales, often referred to as scale-up or scale-down, is a difficult task. This study reviews moving a monoclonal antibody production process from a microscale bioreactor to the Xcellerex XDR single-use platform.

  • Do The Arguments For Pharmaceutical Price Increases Make Sense?
    Do The Arguments For Pharmaceutical Price Increases Make Sense?

    This article will share recent analysis of price increases within the healthcare sector in an effort to understand the growth of healthcare expenditures and pharmaceutical prices over time.

  • Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics
    Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics

    Learn what challenges exist when developing biologic drugs to be efficacious but safe and how novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.

  • Is It Time To Throw In The Towel On Biosimilars In The U.S.?
    Is It Time To Throw In The Towel On Biosimilars In The U.S.?

    Rob Wright takes issue with Peter Bach, M.D., and Mark Trusheim’s recommendation that the U.S. would be better served by abandoning continued biosimilar drug development.

  • Now & Next: Mavupharma
    Now & Next: Mavupharma

    Saurabh Kapure, Vice President, Business Development, USA for Jubilant Biosys, recently sat down with Michael Gallatin, Ph.D., president and co-founder of Mavupharma (Mavu), the drug discovery and development company, to discuss some of the latest developments in the industry and at Mavu. In this Q&A, Dr. Gallatin shares his thoughts about Mavupharma, his role at the company, the evolution of biopharma, drug discovery, development, and the road ahead for the industry with Saurabh.

  • 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.

  • Breast Cancer Patient Organization Sets Sights On Biosimilars
    Breast Cancer Patient Organization Sets Sights On Biosimilars

    During our discussion, I learned more about this patient organization and its biosimilar education goals, as well as what type of information could be particularly helpful for the breast cancer patient community at this point in time.

  • Biosimilar Education Strategies for Physicians And Clinicians
    Biosimilar Education Strategies for Physicians And Clinicians

     

    Free collection of articles highlighting some of the dynamics playing out in the hospital setting for biosimilars, as well as how physicians and drugmakers can foster a greater understanding of biosimilar medicines.

  • What Can Cell & Gene Efforts Teach Biosimilar Makers?
    What Can Cell & Gene Efforts Teach Biosimilar Makers?

    Not only are the issues impacting cell and gene therapies relatable on the biosimilar side, I’m hoping this particular strategy can inspire creative thinking as scrutiny into the buy-and-bill landscape continues to intensify.

  • Cutting Through The Noise: The Bright Side Of Biosimilar Progress
    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.

  • How To Adapt Your Existing Biomanufacturing Process To Maximize Production
    How To Adapt Your Existing Biomanufacturing Process To Maximize Production

    Achieving “smarter”, more flexible workflows requires a complete understanding of today’s novel solutions and technologies, which, when applied appropriately, can push the boundaries of drug development and offer critical advantages in an increasingly competitive industry. 

  • Intensified Chromatography Strategies
    Intensified Chromatography Strategies

    With a newer toolbox of options to intensify downstream manufacturing operations, it is important to understand what factors should impact decisions regarding the implementation of these solutions.

  • Achieving Operational Efficiency In Today’s Fragmented Market
    Achieving Operational Efficiency In Today’s Fragmented Market

    Meeting the goals of today’s industry requires a deeper look at how to continuously achieve maximum utilization and reduce waste without sacrificing quality in the race to be first to market. 

  • 4 Steps Toward End-To-End Connected Manufacturing
    4 Steps Toward End-To-End Connected Manufacturing

    Breaking down the implementation of continuous manufacturing into the following four steps may provide some much-needed guidance as you prepare your network for the future of biomanufacturing.

  • FDA, USP Debate Standards: How Could This Impact Biosimilars?
    FDA, USP Debate Standards: How Could This Impact Biosimilars?

    Even though the FDA has argued quite passionately against the need for biologics standards, there are several reasons why I hesitate to embrace their arguments that having these standards in place (and requiring they be met) could be harmful to biosimilars.

  • Employer Roundtable Highlights Biosimilar Knowledge Gap
    Employer Roundtable Highlights Biosimilar Knowledge Gap

    Though this event encompassed a small cross-section of employers, the discussions and questions asked about biosimilars revealed the topics that need to be considered, reiterated, and regularly reinforced.

  • The Debate On Standards In Biologics Development Heats Up
    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.

  • 4 Key Usability Considerations For Biopharmaceutical Delivery Device Design
    4 Key Usability Considerations For Biopharmaceutical Delivery Device Design

    Often, the last thing on the minds of drug development teams working is the human factors engineering (HFE) performance of the drug delivery devices that will ultimately deliver their innovative medications to patients. Yet, such an oversight can cause major delays in delivering these new medications to market. 

  • The Progress And Pitfalls Of Global Biosimilar Development
    The Progress And Pitfalls Of Global Biosimilar Development

    While we’ve certainly seen progress on the march towards true global development, there’s still a way to go. There were several points I learned recently that stood out about which regulatory inconsistencies still exist between developed nations, as well as how certain aspects of regulatory science can be improved upon in the future.

  • How Can Biosimilars Make Headway In The U.S. Market?
    How Can Biosimilars Make Headway In The U.S. Market?

    ISPOR, the professional society for health economics and outcomes research (HEOR), recently held its annual conference, which brought together nearly 4,000 researchers, regulators, payers, drug developers, providers, and other stakeholders from across the healthcare continuum. During one panel session, experts in biosimilar regulatory, legal, and reimbursement discussed the crucial elements needed to foster a robust and sustainable U.S. biosimilars marketplace over the long term.

  • USP Highlights Biosimilar Analytical Development Challenges, Possibilities
    USP Highlights Biosimilar Analytical Development Challenges, Possibilities

    During our conversation about the FDA’s most recent comparability guidance, I picked one USP expert's brain about the challenges of establishing a biosimilar analytical development program, as well as why certain types of data may be more difficult to come by than others. These challenges are responsible for further complicating the question about which types of data are still necessary, and why.  

  • FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar 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
    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.

  • Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process
    Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process

    This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.

  • Physicians Speak Out About Biosimilar Value
    Physicians Speak Out About Biosimilar Value

    I particularly enjoyed a conversation amongst a panel of physicians at a recent conference, several of whom elaborated upon the value increased use of biosimilars can bring to the table — both for patients and physicians. And though savings and access are main goals, physicians also see another critical benefit of greater biosimilar use.

  • Will Biosimilars Solve The Insulin Cost-Conundrum In The U.S.?
    Will Biosimilars Solve The Insulin Cost-Conundrum In The U.S.?

    The debate on drug pricing is raising questions about why U.S. patients pay some of the highest fees in the world to access prescription medicines. Politicians are putting manufacturers of insulins under particular scrutiny.

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