• Biosimilar Lessons From The EMA
    Biosimilar Lessons From The EMA

    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.

More From Guest Contributors


  • 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


  • From Outsourcing To Partnership
    From Outsourcing To Partnership

    A recent survey by the Economist Intelligence Unit questioned biopharma industry leaders about their plans and concerns for the future. Along with excitement over expanding into novel therapies and emerging markets, they expressed serious concerns about risk mitigation. To combat risk, they raised the potentially contradictory options of building internal capacity and using outside experts. We spoke with Sebastien Ribault – Director of the MilliporeSigma BioDevelopment Center – to get his take on this duality and how it’s changing the nature of partnership.

  • Reducing Analytical Method Steps For Accelerated Product
    Reducing Analytical Method Steps For Accelerated Product

    With an increasing number of products being considered for accelerated development, both the industry and regulators are looking for ways to safely hasten product development and approval times to ensure availability of innovative and low-cost drugs for patients.

  • 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.

  • Direct-to-Patient Practices Improve Clinical Trials For Manufacturers
    Direct-to-Patient Practices Improve Clinical Trials For Manufacturers

    Researchers are increasingly seeing the benefit of a patient-centric approach using the “direct-to-patient” model in order to overcome these challenges and move studies ahead more effectively.

  • A Growing Number Of Pharmas Are Thinking Outside The Box
    A Growing Number Of Pharmas Are Thinking Outside The Box

    Everyone knows the mantra – reduce, reuse, recycle – but reusing temperature-sensitive packaging has not been the normal practice in the pharmaceutical/life science sectors. However, changes are afoot.

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
More Industry Events


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
More Upcoming Courses