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

  • 7 Surefire Ways To Motivate A Life Science Consultant
    7 Surefire Ways To Motivate A Life Science Consultant

    Consultants play a significant role in the pharmaceutical, biopharmaceutical, vaccine, and medical device industries. They are experienced resources in crisis situations; when new facilities are being installed; under circumstances requiring technical expertise; and during regulatory emergencies, remediations, consent decrees, and other planned and unplanned situations. Problems often occur between clients and consultants, and both contribute to them. Motivational enablers/drivers increase the probability that a project will be completed successfully, provided the consultant acquires their own motivational abilities coupled with experience that meets the project requirements.

  • Emerging Best Practices For Contamination Management In Pharmaceutical Manufacturing
    Emerging Best Practices For Contamination Management In Pharmaceutical Manufacturing

    Despite quality audits and third-party oversight, contamination of prescription and over-the-counter (OTC) pharmaceutical products is still prevalent. This is despite the adoption of cGMP practices, SOPs, risk mitigation methods, and metrics such as key performance indicators. We evaluated various emerging practices to overcome contamination issues. Novel batch concentration tests and dedicated capacity utilization have proven to overcome the source of contaminants. For technology adoption in continuous manufacturing, which is unclear in terms of compliance, the FDA Emerging Technology Team could be used for advisory oversight.

  • The Complex Litigation Surrounding Remicade And Its Biosimilar Challengers
    The Complex Litigation Surrounding Remicade And Its Biosimilar Challengers

    Control of the Remicade and biosimilar market is being aggressively contested by Janssen, J&J, Celltrion, Hospira, and Pfizer. This article discusses the legal issues being decided in each of the federal court cases surrounding Remicade.

  • Big Data Vs. Small Data: What’s The Proper Prescription For You?

    This article will explain what Big Data and small data are, build your fluency with the benefits and risks of each, and provide recommendations to improve our data-rich future.

  • When And How To Implement Data Integrity Practices In The Product Development Lifecycle

    Data integrity is frequently discussed in many industries. It is more formally defined within the life sciences industry through regulation (e.g., current good manufacturing practices [cGMPs], good laboratory practices, good clinical practices, the application integrity policy) and in guidance documents from health agencies, including the FDA and WHO. These regulations set the expectations for companies to ensure data integrity and traceability by establishing and monitoring the effectiveness of their quality systems.

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BIOPROCESSING WHITE PAPERS

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • A Call To Action: Industry Innovators Seek New Technologies To Advance Personalized Medicine
    A Call To Action: Industry Innovators Seek New Technologies To Advance Personalized Medicine

    Despite their potential to increase the efficiency healthcare, autologous cell therapy treatments present significant challenges to most companies when it comes to development and manufacturing. 

  • Single-Use Adoption Drives Need For Range Of Sterile Connector Technologies
    Single-Use Adoption Drives Need For Range Of Sterile Connector Technologies

    The adoption of disposable bioprocessing equipment has already been widespread for small-scale applications at the development and clinical manufacturing stages.

  • How To Rapidly Create Single-Use Biomanufacturing Capacity
    How To Rapidly Create Single-Use Biomanufacturing Capacity

    To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.

  • The Future Is “Cloudy” For Data Integrity In Life Sciences
    The Future Is “Cloudy” For Data Integrity In Life Sciences

    Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.

  • Top Five Tips For Chromatography Sample Preparation
    Top Five Tips For Chromatography Sample Preparation

    Chromatography comprises a group of molecular separation techniques commonly used in proteomics to isolate proteins of interest from heterogeneous samples. Despite the fact that these methods are purification strategies in their own right, it would be ill advised to introduce crude sample to your chromatography setup from the outset. The vast majority of samples encountered require some form of processing before they can be placed on the analytical instrument.

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LIFE SCIENCE INDUSTRY EVENTS

Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings November 28, 2017
1pm-2:30pm EST, Online Training
The Top Method Validation Mistakes – And How to Avoid Them November 29, 2017
1pm-2:30pm EST, Online Training
Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle December 6, 2017
1pm-2:30pm EST, Online Training
Auditing Validated Computer Systems In A GxP Environment December 12, 2017
1pm-2:30pm EST, Online Training
Building An Effective GMP Training System: A Risk-Based Approach December 19, 2017
1pm-2:30pm EST, Online Training
More Industry Events

TRAINING COURSES

Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings November 28, 2017
1pm-2:30pm EST, Online Training
The Top Method Validation Mistakes – And How to Avoid Them November 29, 2017
1pm-2:30pm EST, Online Training
Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle December 6, 2017
1pm-2:30pm EST, Online Training
Auditing Validated Computer Systems In A GxP Environment December 12, 2017
1pm-2:30pm EST, Online Training
Building An Effective GMP Training System: A Risk-Based Approach December 19, 2017
1pm-2:30pm EST, Online Training
More Upcoming Courses