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BioQuality - Turning Information into Practical Knowledge

Welcome to BioQuality

Things you can do here:

  • Scroll down to see the latest news from our blog (if you are coming from our Facebook page, the two most recent News posts are always available to everyone; if you want to see earlier posts, just sign up-it’s free-see below)
  • Sign up for a Free Membership. As a Member,
    • you will have access to our complete BioQuality News Blog, and
    • our Special Issues on Biosimilars and Biological Potency (coming soon)
    • Plus, many more great features will be added soon, such as Inspection Results, Compliance Checklists,  mini-Tutorials and more–all free
  • Become a BioQuality Subscriber and enjoy the easy way to keep up with Inspection Results, Stories on regulatory and technical Trends and Hot Topics, the latest Literature, and much more
  • Take a look at a Sample Issue of BioQuality (coming soon)
  • Check back, because we will be adding new features


Subscription Prices (includes 12 monthly issues of BioQuality plus use of our subscriber area at no additional charge):

    • Single subscription (no further reproduction or distribution allowed) $695.00 US per year
    • Small company site license (for companies with 300 or fewer employees; allows you to distribute BioQuality to any employee at your site) Please inquire.
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    • Multiple site license: inquire for pricing information


Our Mission

Our mission is to provide professionals in biologics and biopharmaceutical companies the knowledge they need to function effectively and to avoid problems with the FDA and other regulatory authorities.

BioQuality Newsletter was founded by two scientists, Dr. Laureen Little and Dr. Thomas Pritchett in 1995. They were dissatisfied with how little coverage biologics and biopharmaceutical issues were receiving in existing newsletters. Since that time, BQ has grown into a weekly publication with thousands of readers worldwide and remains the only newsletter that focuses exclusively on biologics and biopharmaceuticals.

Learn More

Subscribe Today & Enjoy:

  • 3 weekly and one combined monthly edition of the only newsletter focused solely on biopharmecutical and biologics quality and regulatory issues. Each Issue includes:
    • Summarized Notices of Deficiency (483s) from recent inspections
    • Lead and other articles covering regulatory and technical Hot Topics and Trends
    • A Literature Search for professionals by a practicing professional
    • Federal Register Notices
  • In addition, all subscribers get full access to the Subscribers Only area of this website featuring:
    • Categorized and searchable 483s from 2010 to the Present (more back years coming soon)
    • Searchable Stories from past issues of BioQuality, 1998 – Present
    • And many new features coming soon


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The Latest BioQuality News

Coming soon!

Coming Soon!

Flurry of Papers Published on Unwanted Immunogenicity

Unwanted immunogenicity is a significant problem for many biopharmaceuticals, and its detection is crucial for development, approval, and successful commercialization of these products. Several papers have been published recently on this important topic. Following are brief synopses of two of these papers. For references to 10 more recent publications, see our upcoming April-May issue. Preclinical

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Turning Information into Practical Knowledge