• 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.  

More From Our Editors


  • 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 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.

  • Best Practices For Data Integrity Oversight At Your Contract Manufacturer

    Part 1 of this two-part article addressed FDA warning letter enforcement actions and discussed things that can go awry in these relationships related to data governance and data integrity. In Part 2, we turn our attention to health authority GMP guidance on contractual relationships and best practices that should be considered in this area.

More From Guest Contributors


  • Be In Control Of Product Quality – Do Not Just Rely, But Understand

    Maik W. Jornitz, President, G-CON Manufacturing LLC

    Past experiences have shown that too often product quality is based on sole reliance of vendor certifications, statements and promises. To diminish such reliance new technologies started to be implemented, like process analytical technologies (PAT), process controls, automation etc. often once again overexerted as the solution to all problems. Activities that supposedly result in higher product quality due to better process controls. Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC

  • Improve Operational Efficiency In Biomanufacturing With Comprehensive Automation Solutions

    This white paper outlines how connectivity and comprehensive automation solution can facilitate technology transfer and scaling from process development to final manufacturing scale.

More Bioprocessing White Papers


More Industry Insights