• Biosimilar Lessons From The EU
    Biosimilar Lessons From The EU

    Suzette Kox, the senior director of the Biosimilars Medicines Group and chair of the biosimilars committee of the International Generic and Biosimilar Medicines Association, offers the European perspective on several topics that are currently being debated in the U.S.

For U.S. Biosimilar Success, Look Beyond Borders

In any industry, there are the experts who become known as the foremost voices of the industry. Biosimilar evangelist, Bert Liang, CEO of Pfenex and chair of the Biosimilars Council describes how far the U.S. biosimilar industry has progressed, as well as how far it has yet to go, offering biosimilar makers some important goals to strive for.

FDA Emphasizes Regulatory Flexibility In Biosimilar Reviews

A study recently published in the BJCP go a long way toward providing a clear example of what regulatory flexibility looks like in the EMA. But where does the FDA, which got a late start with biosimilars, stand in terms of regulatory flexibility today?

How To Prepare Your Biosimilar Company For Interchangeability

While attending a recent biosimilars conference, I heard few clear opinions about whether interchangeability will be a beneficial strategy for biosimilar makers. However, in an interview, Pankaj Mohan, CEO of pure-play biosimilar company Oncobiologics, offered a very straight-forward perspective.

3 Lessons From The GPhA Biosimilars Council Conference

This inaugural conference touched upon many of the topics one would expect, including reimbursement, interchangeability, naming, the global markets, and IP challenges. But I felt three overarching topics were particularly worthy of being singled out.

More From Our Editors


  • A Risk-Based Approach To Environmental Monitoring & Control For Pharmaceutical Distribution

    Over the past few decades, many companies have spent time and capital investment in assessing and mitigating risk factors across the extended supply chain. However, even for those companies that have designed and implemented state-of-the-art operational supply and logistics networks, there is always risk that products may be impacted by variations in temperature, humidity, or other deviations from ideal conditions at any stage across the chain of custody.

  • Single-Use Continuous Manufacturing: The New Paradigm In Biopharmaceutical Processing

    Two significant trends in biopharmaceutical production are coming together. For years, single-use systems have been gaining traction as a way to make processing of biotherapies more efficient. More recently, the industry has also been eyeing continuous manufacturing options to replace traditional “batch” processing methods — again, with the goal of obtaining greater efficiencies.

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  • Controlled Cultivation of Stem Cells – Factors to Consider When Thinking of Scale-Up

    Great hopes and expectations are linked to stem cells as a tool for drug discovery and to stem cell-derived products in therapeutic applications. Though several products have made it to commercial stage, most of the research is still performed in small scales using simple cultivation systems such as spinner flasks or T-flasks.

  • Implementing PAT And Qbd Real-Time Particle Size Measurement For The Pharmaceutical Industry

    As the pharmaceutical industry implements PAT and QbD, their symbiotic nature becomes increasingly obvious. Both are catalysts towards the longer term goals of continuous operation and real-time release — the realization of a transformed way of working. This article reviews changing practice within the pharmaceutical industry using the example of real-time particle size analysis to explore the analytical solutions needed and the benefits they deliver. By Malvern Instruments

More Bioprocessing White Papers


  • Four Steps To Conducting A Successful Data Integrity Audit
    Four Steps To Conducting A Successful Data Integrity Audit

    Auditing is a critical aspect of an overall data integrity assurance plan. To successfully audit the integrity of data, auditors must possess specific knowledge, insights, and skills.

  • 6 Types Of Diseases In Humans Related To Endotoxins Of Gram-Negative Bacteria
    6 Types Of Diseases In Humans Related To Endotoxins Of Gram-Negative Bacteria

    By entering the bloodstream, Gram-negative bacteria cause immune system reactions and lead to the activation of different chains of non-cellular reactions. One of the components of the cell wall of this family of bacteria are lipopolysaccharides, which form complexes of high molecular weight known as bacterial endotoxins, due to the toxic effect that they cause in other organisms.

  • BIO 2016 Survey: Where Is Biopharma Headed?
    BIO 2016 Survey: Where Is Biopharma Headed?

    15,937 industry leaders, 40% of which were C-level executives, attended the BIO International Convention in San Francisco that ran June 6-9. The MilliporeSigma team used this opportune gathering of the biopharma industry to unveil the findings of a study that it recently sponsored with The Economist Intelligence Unit, titled The Changing Biopharma Risk Equation.

  • 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.

  • Selecting The Optimal Resins For Aggregate Removal
    Selecting The Optimal Resins For Aggregate Removal

    The success of any biologic drug, for example, monoclonal antibodies (mAbs), recombinant proteins, or biosimilars, depends greatly on downstream purification. Among the challenges process scientists often face during this process is the formation and/or removal of aggregates of monomers.

More Industry Insights


The Top Method Validation Mistakes – And How to Avoid Them November 2, 2016
1pm-2:30pm EST, Online Training
2016 PDA Outsourcing/CMO Conference November 3 - 4, 2016
Washington, DC
Pharma EXPO November 6 - 9, 2016
McCormick Place, Chicago, IL
Cancer Immunotherapy November 7 - 8, 2016
San Francisco, CA
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The Top Method Validation Mistakes – And How to Avoid Them November 2, 2016
1pm-2:30pm EST, Online Training
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner November 9, 2016
1pm-2:30pm EST, Online Training
Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle November 15, 2016
1pm-2:30pm EST, Online Training
"Powering Up" Your GMP Training - Make Training Fun! November 16, 2016
1pm-2:30pm EST, Online Training
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