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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.

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  • 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:
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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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