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Joanne S. Eglovitch

Senior Editor

Washington DC
Joanne Serpick Eglovitch is a senior editor for “The Gold Sheet” where she writes about manufacturing quality issues. Joanne has over 20 years of experience covering the regulated pharmaceutical and medical device industries, and helped launch the “International Pharmaceutical Regulatory Monitor” and the “International Medical Device Regulatory Monitor”. Previously Joanne covered the mortgage finance industry and the mortgage capital markets, and employment and training programs. Before her forays into newsletter journalism, Joanne worked as a general assignment reporter for a twice-weekly newspaper in southern Maryland and an editorial assistant for “Insight” Magazine, published by “The Washington Times.”
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Latest From Joanne S. Eglovitch

FDA Reports Growing Use Of Process Modeling Tools To Support Continuous Manufacturing

FDA reports “growing traction” of continuous manufacturing and a corresponding uptick in the use of models to support this mode of manufacturing. Officials explain how they assess these models during inspections.
Manufacturing Quality

NIIMBL Issues Roadmaps For Advancing Gene Therapy, Vaccine And Antibody Drug Conjugate Manufacturing

A public/private manufacturing technology partnership has produced three roadmaps to help the biopharmaceutical industry navigate some of the regulatory and analytical hurdles in developing and manufacturing gene therapies, vaccines and antibody-drug conjugates. All three roadmaps cite a knowledge gap in the industry and the need for an adequately trained workforce.

United States Manufacturing

Firms Should Characterize Their Cell And Gene Therapies Early, FDA Says

US FDA official advises that to avoid the “brick wall” of BLA rejection, manufacturers should characterize their cell and gene therapy products and develop potency assays as early as possible.

United States Manufacturing

US FDA Recommends Use Of Pre-Built Facilities To Ease Scale-Up Process For Cell And Gene Therapies

As applications for expedited review of cell and gene therapies soar, it is important for their sponsors to take certain steps to enhance prospects for smooth commercial scale-up, the director of US FDA’s center for biologics suggests.

United States Manufacturing

USP Sparks Debate Over Rapid Sterility Testing For Cell And Gene Therapies

For short-lived cell and gene therapies that must be given to patients before traditional sterility testing results can be obtained, the question is whether less sensitive rapid tests that can be completed in advance might be a better choice. Should manufacturers demonstrate a lack of viable microorganisms, or is it OK merely to show there aren’t enough of them to produce an “infectious dose”?

United States Europe

FDA Outlines Systems Manufacturers Should Have In Place For Handling Suspect Drugs Under DSCSA

Manufacturers need to have robust verification processes in place and actively communicate with their trading partners to handle suspect drugs that are not properly serialized under DSCA, FDA draft guidance document says.

United States Manufacturing
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