EDITOR'S DESK

  • The Debate On Standards In Biologics Development Heats Up
    The Debate On Standards In Biologics Development Heats Up

    Though it’s only natural to expect animated scientific discussion between the FDA and USP which have long been partners-in-science, I found myself caught off-guard by just how firmly the FDA has been putting its foot down and making its thoughts known on the role certain standards — in particular, USP monographs — should (or should not play) in biologics development.

FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?

In this first of what will be a two-part article, USP's Fouad Atouf highlights the challenges presented by the FDA’s newest guidance while remaining optimistic that the large amount of data recommended today will open doors to more efficient development in the (hopefully) near future.

Why We Should Celebrate The FDA’s Biosimilar Comparative Analytics Guidance

Despite the importance of the process the FDA is outlining in the guidance, I’ve surprisingly heard little chatter — positive or negative — about what the agency is now outlining and what this may mean for biosimilars and the biosimilar regulatory paradigm moving forward. Here are a couple of the biggest takeaways to note.

3 Countries To Watch In The MENA Region

Though there is a large handful of countries that, to date, don’t have biosimilar pathways established, a few countries have been slowly gearing up to be leaders in paving the way for biologics and biosimilars. In this article, I’ll discuss the potential of these three markets, as well as the business considerations Challand highlighted for companies considering entering the MENA region.

MENA: Biosimilar Market Challenges And Regulatory Considerations

Throughout her presentation, Challand gave us a good look at the current state of the biologics market in MENA and the ongoing educational and collaborative efforts that could help shape the markets in this region. She also shared several important considerations for regulators and biosimilar companies looking to expand their business to MENA.

More From Our Editors

GUEST CONTRIBUTORS

  • 4 (More) Microbiological Root Cause Analyses Lessons From Sherlock Holmes
    4 (More) Microbiological Root Cause Analyses Lessons From Sherlock Holmes

    Bias can take many forms and is often not easily recognized by an investigator. Sherlock Holmes was keenly aware of bias' potential impacts and so did not allow bias generated through speculation, random hypothesis, or previous experience to determine or redirect the course of his investigations. Applying more of Holmes’ famous observations and investigative principles can uncover hidden bias and greatly increase an investigator’s chance of finding that elusive definitive root cause.

  • Applications For Single-Use Systems In Biosimilar Development
    Applications For Single-Use Systems In Biosimilar Development

    Exploring the benefits, challenges, and future of disposable systems in biosimilar manufacturing.

  • Cutting Packaging Costs: What Life Sciences Can Learn From Consumer Packaged Goods
    Cutting Packaging Costs: What Life Sciences Can Learn From Consumer Packaged Goods

    Industries can (and should) learn from one another. As the life sciences market continues to become more competitive and social pressure to reduce healthcare costs increases, consumer packaged goods (CPG) approaches and strategies to cut packaging costs can be applied to life sciences to achieve these objectives. 

  • IPR For Biosimilars: Examining The Benefits And Drawbacks

    Whether Inter Partes Review (IPR) is the right choice for biosimilar developers will depend on the particular circumstances surrounding each drug candidate. But given the benefits of IPR proceedings, they must at least be considered as a potential tool for challenging patents.

  • Equipment Change Control For GMP Production Facilities — Proving It All Works

    The first article in this two-part series outlined the six primary stages of equipment change control and discussed the first two stages: (1) determining the equipment utility/IT requirements and (2) pre-installation assessment, utility evaluation, and remediation. This article describes the final four stages of this process: (3) evaluating the impact of new equipment installation on previously validated utilities, (4) executing validations for new equipment, (5) review of equipment turn-over packages and validation reports, and (6) performing change control effectiveness checks.

More From Guest Contributors

BIOPROCESSING WHITE PAPERS

  • Off-Site Storage Of Biological Specimens And Biologics For Risk Mitigation

    Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment.

  • Avoiding Hemolysis Blood Sample Collection Processing

    Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state then it is equally important that hemolysis and the need for a re-draw is avoided. This paper explains how hemolysis can be prevented during specimen collection and handling.

More Bioprocessing White Papers

FREE CLEANING VALIDATION E-BOOK

Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.

INDUSTRY INSIGHTS

  • The Pivotal Role Of Standardization In FFPE Tissue Block Collection
    The Pivotal Role Of Standardization In FFPE Tissue Block Collection

    Given the significant potential of formalin-fixed paraffin-embedding tissues, this material must be collected, documented and preserved properly in order to gain its full potential.

  • 5 Proven Steps To Successfully Select & Onboard Outsourced Logistics Partners
    5 Proven Steps To Successfully Select & Onboard Outsourced Logistics Partners

    In preceding articles in this series, we reviewed some of the challenges and remediation approaches for the storage and distribution of life science products, highlighting some of the specific risks related to storage, transportation, and material control across an extended chain of custody. This brings us to the final article, in which we will discuss best practices for selecting the partners that will be an extension of your staff for monitoring and control across an ever-changing global landscape.

  • Are You Asking Too Much From Your Filler?
    Are You Asking Too Much From Your Filler?

    The core mission of the pharmaceutical industry is to manufacture products for patients to cure them, vaccinate them, or alleviate a symptom, often by manufacturing a liquid injectable or an oral solid, among other therapies. In this article, we will focus on the aseptic injectable, from a general standpoint, to see what we are doing with our aseptic filling systems and why.

  • Bispecific Antibody Purification: Insights And Case Studies
    Bispecific Antibody Purification: Insights And Case Studies

    New modalities, like bispecific antibodies, present unique challenges compared to mAb production. For purification, there’s not just one right answer to which strategy to use. Here are some industry insights to help you navigate the bispecific jungle.

  • Equipment Change Control For GMP Production Facilities — Proving It All Works
    Equipment Change Control For GMP Production Facilities — Proving It All Works

    The first article in this two-part series outlined the six primary stages of equipment change control and discussed the first two stages: (1) determining the equipment utility/IT requirements and (2) pre-installation assessment, utility evaluation, and remediation. This article describes the final four stages of this process: (3) evaluating the impact of new equipment installation on previously validated utilities, (4) executing validations for new equipment, (5) review of equipment turn-over packages and validation reports, and (6) performing change control effectiveness checks.

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

FDA's eCTD Ad-Promo Guidance Is Finalized: Are You Ready? August 7 - 7, 2019
1pm-2:30pm EDT, Online Training
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error August 8 - 8, 2019
1pm-2:30pm EDT, Online Training
More Industry Events

TRAINING COURSES

FDA's eCTD Ad-Promo Guidance Is Finalized: Are You Ready? August 7 - 7, 2019
1pm-2:30pm EDT, Online Training
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error August 8 - 8, 2019
1pm-2:30pm EDT, Online Training
More Upcoming Courses