EDITOR'S DESK

  • A Glimpse Into Thailand’s Ongoing Life Sciences Transformation
    A Glimpse Into Thailand’s Ongoing Life Sciences Transformation

    During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.

What Thailand Revealed About U.S. Pharma R&D

A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.

What To Know About Thailand’s Life Sciences Industry

About a month ago, I was offered a tremendous opportunity: to attend a media trip to Thailand to learn about the country’s burgeoning life sciences industry. Like many people in the life sciences industry, I had no idea just how much has been going on within the country in terms of life sciences.

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.

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GUEST CONTRIBUTORS

  • 7 Steps To Move Commercial Manufacturing Into Six Sigma’s “Control” Phase
    7 Steps To Move Commercial Manufacturing Into Six Sigma’s “Control” Phase

    The readers of this occasional column on the basics of Six Sigma applied in the pharma space are likely aware that we’re at our final step in our Six Sigma DMAIC roadmap, that of Control. 

  • Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination
    Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination

    Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects.

  • An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities
    An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities

    Beginning in 2004, a global team of pharmaceutical toxicologists, industrial hygienists, quality assurance professionals, a cleaning validation professional, and a representative from the US FDA participated in the development of the International Society for Pharmaceutical Engineering's (ISPE) Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP) Baseline Guide.

  • Beyond The FDA Guidance: Practical Considerations For Quality Agreements

    Much has been written in recent months about the FDA’s final guidance for industry, Contract Manufacturing Arrangement for Drugs:  Quality Agreements, issued in November 2016.  Recently, a thorough assessment of the guidance requirements and gaps was published on this website. (See FDA's New Quality Agreement Guidance — What It Says (And What It Fails To Say) and Examining FDA's New Quality Agreement Guidance.)

  • Building A Productive Relationship With FDA: Beyond The Science

    Whether your relationship with the FDA starts with pre-IND feedback or simply with an IND submission itself, these early interactions will likely form the basis for a long (and hopefully happy) marriage.  After all, this liaison could very well last beyond submission and initial approval of a marketing application to include additional trials relevant to the drug’s development and labeling.  As there is no manual available for building an effective and collegial relationship with the FDA, this article offers helpful tips to assist sponsors in establishing and maintaining this critical union.

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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.

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INDUSTRY INSIGHTS

  • Considerations To Ensure Successful Scale-up Of Single-use Processes
    Considerations To Ensure Successful Scale-up Of Single-use Processes

    Considerations to ensure successful implementation of single-use automation from laboratory-scale to large-scale production.

  • What’s Next For Single-Use Technology In Bioprocessing
    What’s Next For Single-Use Technology In Bioprocessing

    The advantages of single-use are well-known — faster, smaller, greener, cheaper, and safer — and increasing numbers of biomanufacturers have sought to reap these benefits, especially as patent expiration and increasingly globalized manufacturing continues to change the dynamics of biomanufacturing.

  • 3 Steps To Prepare For FDA’s Final Quality Metrics Guidance
    3 Steps To Prepare For FDA’s Final Quality Metrics Guidance

    Reacting to trends, including drug shortages and plant inspections that increasingly question manufacturing data integrity, FDA’s recent draft guidance Request for Quality Metrics promotes a “quality-driven corporate culture” as one of its goals.

  • CDMOs — At The Core Of Next-Generation Pharma Models
    CDMOs — At The Core Of Next-Generation Pharma Models

    In today’s pharmaceutical industry, the economic strains of keeping a company completely vertically integrated are no longer feasible. Smaller, virtual drug companies simply do not have the resources necessary to translate a molecule to a drug product.

     

  • Ensuring Barcode Accuracy From Packaging To The Patient
    Ensuring Barcode Accuracy From Packaging To The Patient

    Barcodes have changed very little over the last 60 years. Yet for pharmaceutical companies the barcode has taken on a vital role throughout the product’s lifecycle from original packaging to in hospital unit dose identification.

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LIFE SCIENCE INDUSTRY EVENTS

Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner June 7, 2017
1pm-2:30pm EDT, Online Training
Cell Therapy: Process Design Considerations To Support Commercialization June 13, 2017
1pm-2:30pm EDT, Online Training
DIA 2017 Annual Meeting June 18 - 22, 2017
Chicago, IL
BIO 2017 International Convention June 19 - 22, 2017
San Diego, CA
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