EDITOR'S DESK

  • Behind Samsung Bioepis’ 5-Year Rise To Biosimilar Fame
    Behind Samsung Bioepis’ 5-Year Rise To Biosimilar Fame

    Samsung Bioepis celebrated its fifth anniversary in February 2017. I met with Paul Song, VP at Samsung Bioepis, to learn more about the company's motto, "Process innovation," which is credited for the company's swift rise to leadership in the European market.

Biosimilar Makers To Congress: Time To Act On REMS Legislation

REMS and voluntary restricted distribution programs have become a significant stumbling block for biosimilar companies. The Subcommittee on Health Care, Benefits, and Administrative Rules recently held a hearing on these controversial practices. If there was one big takeaway from the presenting witnesses, it’s that the biosimilars industry is ready for legislative action against these abuses.

The 4 Most Notable Biosimilar Interchangeability Hurdles

Though the interchangeability draft guidance seemed to be well-received by biosimilar makers, I’m hesitant to interpret the surprising post-guidance quietness to mean companies have no concerns about the bar it sets for attaining interchangeability.

IQPC Biosimilars Event Emphasizes Need For Regulatory Alignment

I recently attended the IQPC Biosimilars Analytical Similarity, Clinical Studies, and Market Entry conference. This event, which took attendees into the heart of biosimilar development (the analytical and statistical work) was a great example of the scientific challenges developers may face while working with different regulatory agencies.

Should Your Biosimilar Really Be A Biobetter?

A few months ago, Eagle Pharmaceuticals agreed to acquire Arsia Therapeutics.This move will help Eagle partner with biosimilar companies to turn biosimilar candidates into biobetters. As Eagle CEO Scott Tarriff describes, the company’s business model of reformulating and improving existing small molecules is well-suited to the biologics space — especially considering his expectations of how the biosimilar space will play out.

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GUEST CONTRIBUTORS

  • Are “Do-Overs” Practical In Biopharmaceutical Manufacturing?
    Are “Do-Overs” Practical In Biopharmaceutical Manufacturing?

    What should a manufacturer do when an API (drug substance) or intermediate from a biopharmaceutical manufacturing process does not meet specification, or when a process has operated outside the validated operating range?  What if, for instance, a chromatography step does not reduce the host-cell protein content to the required amount due to overload of protein or a variation in buffer pH?

  • Amgen Vs. Sandoz: Who Will Win Over The Supreme Court?
    Amgen Vs. Sandoz: Who Will Win Over The Supreme Court?

    These are formative days for biosimilar developers in the U.S. courts. Last month, the biosimilar market witnessed its first legal settlement, between Mylan and Genentech for trastuzumab, and further settlements are sure to follow. On April 26, the Supreme Court began hearing the case between Amgen and Sandoz regarding the infamous “patent dance.” The Court’s ruling (expected in July) will have significant ramifications on how quickly new biosimilars reach the market.

  • Brexit & The Biopharma Industry: What Happens Next?
    Brexit & The Biopharma Industry: What Happens Next?

    Last year, after the fateful June 2016 Brexit referendum that ended in a shocking win for the “Leave” camp, I wrote an article discussing the options going forward and the uncertainty that faced the biopharmaceutical industry. Now, almost a year later and after the official triggering of Article 50 — through a letter delivered by Eurostar, no less — have we actually learned anything new?

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BIOPROCESSING WHITE PAPERS

  • The Future of BioManufacturing

    The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.

  • Checklist For Multivariate Analysis Best Practice

    You are unlikely to create the final model in your first attempt. Use the power of multivariate analysis to select interesting samples based on the instrumental measurements before you put them through the lab.

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Making Novel Therapies A Reality Part 1
    Making Novel Therapies A Reality Part 1

    Cell therapy, gene therapy, and RNA-based therapies. Right now, those are the classes of therapies we’re considering novel. If you look at it historically, ten years ago, recombinant proteins and monoclonal antibodies would have been novel therapies, but now they’ve become very much standardized. So now that bar has moved a little bit, and the novel therapies are really cell and gene therapies, and to a certain extent the RNA therapies.

  • Top Five Tips For Chromatography Sample Preparation
    Top Five Tips For Chromatography Sample Preparation

    Chromatography comprises a group of molecular separation techniques commonly used in proteomics to isolate proteins of interest from heterogeneous samples. Despite the fact that these methods are purification strategies in their own right, it would be ill advised to introduce crude sample to your chromatography setup from the outset. The vast majority of samples encountered require some form of processing before they can be placed on the analytical instrument.

  • The Multivariate World Is Expanding For Research And Industrial Data Analysis
    The Multivariate World Is Expanding For Research And Industrial Data Analysis

    The field of chemometrics has been around for quite some time now and has played its role in both research and industrial environments. While the multivariate research toolbox is well established and ever increasing, its industrial counterpart is only beginning to see widespread use in the last decade.

  • Integrating Quality Control Tools Into Print Workflow Automation Solutions
    Integrating Quality Control Tools Into Print Workflow Automation Solutions

    Artwork must be right the first time and every time. Even a simple mistake has the potential to be catastrophic, resulting in product recalls, fines, write-offs and potential lawsuits.

  • The Standardization Of Single-Use Components For Bioprocessing
    The Standardization Of Single-Use Components For Bioprocessing

    As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. 

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