EDITOR'S DESK

  • DIA Biosimilars Conference Reveals “More Questions Than Answers”
    DIA Biosimilars Conference Reveals “More Questions Than Answers”

    During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”

Pfizer’s Cultural Evolution To “Tell The Biosimilar Story”

Pfizer's Tracy Dianis presents a candid look into the cognitive and cultural transition that needed to occur in her own mindset, as well as within Pfizer, in order to embrace biosimilar development.

Biosimilar Regulatory Best Practices: Don’t Fear Exploration

In the first of this two-part article, Sandoz's Cindy Cao shares lessons learned from working with the FDA and reveals that there is still a lot of room for exploration and innovation in biosimilar development.

What These Two Mottos Must Mean For The Biosimilar Industry

I recently attended the Association for Accessible Medicines (AAM) Biosimilars Council’s Leading on Biosimilars conference.In addition to the many tidbits of knowledge I took away from this event, two terms kept resurfacing throughout the conference I feel are worth delving into more deeply.

Pfenex’s New CEO Sizes Up Biosimilar Industry’s Future

Newly-appointed Pfenex CEO, Eef Schimmelpennink, faces the challenge of determining how to adapt Pfenex to a constantly changing future. Though it's still very early in his tenure, Schimmelpennink highlights some areas he will keep in mind as he steers Pfenex's future biosimilars onto the market.  

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GUEST CONTRIBUTORS

  • Using Quality Tools To Build A Cohesive R&D Environment
    Using Quality Tools To Build A Cohesive R&D Environment

    Developing products in the life sciences industries is complex. Basic quality tools can be used to bring the complexity into focus and help streamline the development strategy. These tools can help identify your primary goals and assess potential risks and failure modes to enable agile thinking early in development, where experimental outcomes often indicate the need to alter your development strategy.

  • A Framework For Measuring Training ROI Using Quality Metrics
    A Framework For Measuring Training ROI Using Quality Metrics

    This article proposes an approach using data-driven insights from standard quality culture and performance metrics, with CoPQ calculations, to measure training return on investment (ROI). Calculation of ROI answers the question, “Is this investment worth the expense?” It measures how much money is earned or lost from investment in training and the impact of training on the bottom line.

  • An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection
    An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection

    This article discusses how the maximum safe surface residue (MSSR) can be combined with the visual residue limit (VRL) to assess the acceptability of visual inspection for detecting the possibility of compound carryover in shared facilities.

  • The FDA/EU Mutual Recognition Agreement — What You Need To Know

    The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether statutory and regulatory requirements of the respective authorities have been met.

  • Bioprocessing Trends To Watch In 2018

    The current situation in biopharma is exciting, with new technologies, biosimilars, cellular and gene therapies, and opportunities in emerging markets.  And these innovative platforms are going to continue to need improved manufacturing technologies in the future.

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BIOPROCESSING WHITE PAPERS

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INDUSTRY INSIGHTS

  • What Water Treatment Advancements Mean For Pharma
    What Water Treatment Advancements Mean For Pharma

    Pharmaceutical water is key to the production of pharmaceutical drug products, and there have been a number of technological advancements in high-purity pharmaceutical-grade water.

  • The Changing Biopharma Risk Equation
    The Changing Biopharma Risk Equation

    As pharma companies expand, they are looking more and more to biologics for their next potential blockbusters. However, this class of product—ranging from well-established large molecule drugs to truly novel therapies—poses major challenges because of their scientific complexity and sophisticated development requirements.

  • Keys To Successful Implementation Of Single-Use Technology
    Keys To Successful Implementation Of Single-Use Technology

    How and why collaboration improves single-use products.

  • Comprehensive Solutions For Aggregate Issues
    Comprehensive Solutions For Aggregate Issues

    Aggregate molecules are mostly physically and chemically similar to monomers, their presence in the final purified product, especially a therapeutic mAb, is undesirable due to multiple reasons. 

  • Speaking The Regulatory Language
    Speaking The Regulatory Language

    The recent survey by the Economist Intelligence Unit asked biopharma execs about their hopes and concerns for the future of the industry. The results showed there was great excitement about the emergence of new markets and novel therapies, but this was tempered by worry over the complex maze of regulatory requirements. We spoke with Frithjof Holtz, Director of Advocacy and Surveillance for MilliporeSigma, to explore the interplay of emerging markets and regulatory harmonization.

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