• For U.S. Biosimilar Success, Look Beyond Borders
    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.

Biobetters: How Much Competition Should Biosimilar Makers Expect?

In the last few weeks, news stories have surfaced reminding the biosimilar industry that biobetters are alive and, for the most part, well. Overall, there are upwards of 500 biobetters in development worldwide. But should the biosimilar industry really be concerned about biobetters quashing the use of biosimilars?

More From Our Editors


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

  • Utility System Design Considerations For Single-Use Bioprocessing
    Utility System Design Considerations For Single-Use Bioprocessing

    Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. This article is the fourth in a six-part series on how single-use systems are changing the modern biotechnology facility and process design paradigm.

  • Quality Systems 101: Basic Concepts & Considerations

    Whether you are a life science startup with a brick-and-mortar office or working as a virtual company, at some point the question comes up: Do we need a quality system? Or perhaps your question is, What is a quality system?

  • 6 Tips For Better Time Management In Pharmaceutical Operations

    We all want to maximize the productive use of our time, correct? Over the span of my pharmaceutical industry career, I have been fascinated with this topic. It started when one of my supervisors in supply chain gave copies of The 7 Habits of Highly Effective People to me and the rest of his staff, which became one of many books on time management I have read.

More From Guest Contributors


  • Race Is On To Discover Vaccine To Save Salmon Originally, Microtek International Ltd. worked with a French press and Gaulin homogenizer, but they posed contamination and equipment cleaning problems. After a demonstration at the lab, the Microfluidizer processor's performance and sterilization features convinced Microtek to get one immediately. Submitted by Microfluidics
  • Grant Payment Practices: Five Requirements For Stronger Investigator Relationships

    In the clinical trials industry, profitability and regulatory compliance pressures continue to mount. Consequently, pharmaceutical companies are striving to maximize their research and development spending by reducing clinical trial cycle times and focusing on their core competencies—all while maintaining high standards of quality. By James M. Dicesare and Kevin T.Williams, Clinical Financial Services, LLC (CFS).


More Bioprocessing White Papers


  • Solutions to Today’s Biomanufacturing Challenges
    Solutions to Today’s Biomanufacturing Challenges

    With more complex molecules in development, changing capacity needs, uncertain forecasts and increased competition, the market demands flexibility and innovative approaches to address today’s new challenges.

  • 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.

  • 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.

  • Reducing Upstream Processing Scale-Up Risks Using QbD
    Reducing Upstream Processing Scale-Up Risks Using QbD

    Scientists and engineers seeking to develop manufacturing processes for new biopharmaceutical drugs face a number of challenges. Upstream process development must deliver a high-yielding cell culture to meet Cost of Goods (CoGs) objectives. The process must be robust to ensure high batch success rates with a low risk of contaminations and minimal variations in cell growth performance. The biological product must maintain the required product quality attributes, during scale-up from laboratory to commercial scale. Biopharmaceutical companies must address these complex challenges in the shortest possible timeframe and at reasonable effort and cost during development. Doing so allows the early evaluation of products in the clinic and, therefore, effective resource allocation behind projects from the pipeline that are most likely to be successful all the way to the market.

  • When Orphan Drugs Make All The Difference
    When Orphan Drugs Make All The Difference

    Orphan drugs, those medications that are typically produced in small quantities for limited patient populations, are growing in importance worldwide. Once largely considered too costly to produce, given the limited number of patients affected by a particular disease, new technology and new breakthroughs in biopharma have changed the landscape, allowing more orphan drugs to be produced than ever before, thus saving countless lives that would otherwise be lost.

More Industry Insights


2nd Antibody Drug Conjugates Conference October 24 - 25, 2016
Boston, MA
4th Antibody & Protein Therapeutics Conference October 25 - 26, 2016
Boston, MA
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
More Upcoming Courses