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Tag: Sterility

August 5, 2025

Challenges in Sterile Filling

Clinical, CMC, Parenteral Drugs, Pharmaceutical Development, Pharmaceutical Manufacturing

Stuart R. Gallant, MD, PhD Parenteral products require sterility whether they are liquid vials, lyophilized vials, or prefilled syringes.  This week’s post on Pharmatopo addresses…

Stuart Gallant
June 11, 2025

Small Molecule and Antibody Release Specifications—Lessons Learned

Analytical, CMC, Knowledge, Parenteral Drugs, Pharmaceutical Manufacturing

Stuart R. Gallant, MD, PhD Drug substance and drug product release specifications have numerous uses throughout the product lifecycle.  They guide process development and provide…

Stuart Gallant
September 1, 2023

Subcutaneous Suspensions for Challenging Formulations

CMC, Parenteral Drugs, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmacy

Stuart R. Gallant, MD, PhD In today’s post, we will look at subcutaneous suspensions as a way of meeting difficult drug delivery challenges.  To decide…

Stuart Gallant

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