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.

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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.

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BIOPROCESSING WHITE PAPERS

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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

  • Cut It Out: The Role of Gene Editing Technologies in Combating HIV
    Cut It Out: The Role of Gene Editing Technologies in Combating HIV

    HIV has been one of the largest public health challenges facing the world in the past few decades. Approximately 36.7 million people were infected with HIV, as reported by the World Health Organization, at the end of 2015. Despite the public attention and large population impacted by this virus, developing a cure for HIV has been particularly difficult. To successfully cure an infected individual the virus would need to be fully eradicated from their body, which is difficult because HIV is extraordinarily good at hiding in a person’s cells. In fact, part of the virus’ replication cycle is to insert itself into the host’s DNA. Once there, HIV appears to be undetectable and it can stay in the cells for the lifetime of the cell. In this state, the virus is termed “latent.”

  • Data Integrity, Startups, & Cloud Storage: Don’t Let This Happen To You!
    Data Integrity, Startups, & Cloud Storage: Don’t Let This Happen To You!

    Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.

  • Bad Quality Is Contagious: Stop Before It Spreads
    Bad Quality Is Contagious: Stop Before It Spreads

    Disregarding the rules in the regulated industry is like a contagious disease. If you don’t control it in the beginning, you and your organization will be lost. In advanced stages, it could require the termination of many employees with this disease.  When the FDA recommends you hire fresh eyes for quality systems on a warning letter, it actually means your problem is institutionalized. That’s why I recommend a biannual general audit by a third party. Even if you think you can go more than two years without an audit, this bad behavior can grow roots and can infect the quality culture of your organization. Then, when you do receive a visit from the FDA, it will be easier to correct unwanted behaviors and to renew your quality system, if needed. By Rosario Quintero-Vives, Sr. Regulatory & Compliance Specialist, RQV Consulting

  • Environmental Isolates: What’s The Proper Use Of In-House Cultures?
    Environmental Isolates: What’s The Proper Use Of In-House Cultures?

    Use of environmental isolates in the pharmaceutical microbiology laboratory has been increasing in popularity. This article discusses the current regulations andguidance documents, regulatory expectations, and expert opinions on the use of environmental isolates.

  • The U.S. Biosimilar Market: Where Is It Today? Where Is It Going?
    The U.S. Biosimilar Market: Where Is It Today? Where Is It Going?

    The U.S. biosimilar market is relatively new. It took another two years for the FDA to issue the first draft guidelines for developing and registering a biosimilar in the United States, and another three years until the first biosimilar was approved.

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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
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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
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