GUEST COLUMNISTS

  • Samsung Bioepis CEO: A COVID-19 Call To Action

    There is a lot of speculation around exactly just how this pandemic will impact our own FDA timelines. But whether a drug will get approved several months later than expected is not the core issue on which we should be focused — it’s the consequences these delays or changes in our day-to-day work might have for people with severe and chronic illnesses.

  • Your Drug Or Mine? Managing Drug Delivery Device Differentiation Hazards

    To ensure that patients receive the correct product and medication dosage and to minimize the potential for medication error, drug delivery devices must be designed both to be differentiable from similar products and also to facilitate distinguishability between varying doses of the same medication.

  • How Will COVID-19 Impact Biosimilar Trends In The Top 5 European Markets?

    It is undeniable that COVID-19 will have a significant impact on biosimilar uptake, particularly in European markets in which governments cover citizens' pharmaceutical needs and where the crisis will lead to an important reduction of available resources. However, it is difficult to assess the extent to which this will occur.

  • Insulin Under The BPCIA: Opportunities And Obstacles

    As of March 23, 2020, insulin now falls under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This regulatory shift presents both new opportunities and new obstacles for developers of follow-on insulin products.

  • What To Expect From The FDA During (And After) COVID-19

    More than 100 non-COVID-19 trials have been put on hold, and only 14 percent of sites are open for enrollment. This dynamic forces an evaluation of the regulatory impacts our industry faces in the wake of COVID-19 and what to expect in the months ahead.

  • Do We Need Comparative Clinical Efficacy Testing For Biosimilars?

    This article examines the nature of comparative efficacy testing and suggests that these studies may be providing misleading evidence of safety and efficacy of biosimilars and should be replaced with more objective pharmacokinetic studies.

  • Which Biosimilar Companies Will Thrive In 2025?

    Five years after the first biosimilar was made available for prescription in the U.S., the American biosimilar market may be turning a corner on the road to sustainability.

BIOSIMILAR WHITE PAPERS

  • Increasing Productivity In Hydrophobic Interaction Chromatography (HIC) Using Capto Resins

    Downstream processes for biomolecule purification are becoming more complex. Challenges include increasing titers from upstream cell culture, greater diversity of target molecules, and a need for better productivity. HIC has characteristics designed to solve these challenges. In this study, the hydrophobicities of newer generation Capto HIC resins were compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.

  • Digital Manufacturing Of Biologics

    In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. 

  • Trends In Protein Separation And Analysis — The Advance Of Stain-Free Technology

    Stain-free technology, a technology that existed in principle since early 2000 but was only commercialized in 2010 has changed the protein separation and analysis landscape in the past few years. This article focuses on how protein visualization is accomplished using stain-free technology, its advantages and concerns as well as how stain-free technology can change the way we carry out protein separation and analysis.

  • Robust Business Continuity Program Helps To Maintain Operations In The Face Of Crisis

    Experts at Cytiva provide insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

  • Gene Selection Using PrimePCR Plates And CFX Maestro Software

    Reference gene selection and validation are very important for gene expression studies that involve different samples or experimental conditions and therefore are absolutely necessary before any further exploration. Read how PrimePCR Reference Gene Selection Panels provide an easy-to-use system with which to select appropriate reference genes.

  • 6 Regulatory Changes Affecting Bioprocessing In China

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

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BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS

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In this e-book, experts from a wide range of settings of care explain their successful biosimilar implementation initiatives, the evolving healthcare treatment landscape, and which systemic barriers still must be overcome to improve education and uptake.

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