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Though the interchangeability draft guidance seemed to be well-received by biosimilar makers, I’m hesitant to interpret the surprising post-guidance quietness to mean companies have no concerns about the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

  •  Trump’s Deregulatory Agenda:  What It Could Mean For Biopharma & Medtech Companies
    Trump’s Deregulatory Agenda: What It Could Mean For Biopharma & Medtech Companies

    President Trump promised to take action to streamline the federal government. Within just a few days of taking office, he launched his deregulatory agenda, and he has now issued several executive orders that build on each other. How the concept will be implemented and by whom will continue to evolve with the addition of key staff.

  • How To Optimize Your Stability Program At Each Phase Of Drug Development [Checklists Included]
    How To Optimize Your Stability Program At Each Phase Of Drug Development [Checklists Included]

    A drug stability program that is above reproach is critical to successfully navigating the complexities of drug development. A well-managed stability program with thoughtfully constructed protocols demonstrates your lab and quality systems are in control.

  • FDA’s Quality Metrics Guidance: Reading Between The Lines
    FDA’s Quality Metrics Guidance: Reading Between The Lines

    One week before we published the article 5 Important Takeaways From The FDA's Revised Quality Metrics Guidance, Life Science Connect attended a thought-provoking presentation about said guidance at a local ISPE event in Philadelphia. While the article covered several key things the guidance document did communicate to industry, the ISPE presentation — given by Lou Angelucci, currently a project management consultant to Johnson & Johnson — focused more on what the guidance document failed to say and do … and the implications of those omissions. We tracked down Lou after his talk and asked him to elaborate on some of the issues he had raised.

  • 4 Key Considerations When Engaging A New GMP Contract Service Provider

    Integrating a contract service provider (CSP) as part of a supply chain to bring a product to market is a critical decision that impacts business performance and carries regulatory and compliance risk. The selection considerations can vary substantially as your program moves from early development contract research to commercial manufacturing and analytical support.

  • Are You (Inadvertently) Teaching Your Personnel To NOT Think?

    At a GxP Training and Networking Symposium, I had the opportunity to talk to a variety of people I hadn’t interacted with before. A common theme in many of my conversations was a little disturbing.

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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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LIFE SCIENCE INDUSTRY EVENTS

Best Practices in CMC Dossier Preparation – Facing Tough Challenges April 24, 2017
1pm-2:30pm EDT, Online Training
CellWorld April 25 - 26, 2017
San Fancisco, CA
Cleanroom Microbiology – A Foundational Introduction April 27, 2017
1pm-2:30pm EDT, Online Training
More Industry Events