March 27th 2025
In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.
February 25th 2025
Drug Digest: The Shape of Things to Come: Advances and Improvements in Excipients
November 23rd 2023In this episode of Drug Digest, Pharmaceutical Technology’s European/Senior Editor, Felicity Thomas, chats about the biggest trends impacting oral and topical drug delivery and how these trends are impacting the excipient sector with Nick DiFranco and Ashley Rezak from Lubrizol Life Science Health.
mRNA Advances Allow Drug Development Focus on Rare Diseases (Part One)
November 14th 2023A discussion with Thomas Langenickel, MD, chief medical officer at Ethris, shines a light on how advances made with mRNA technology are also advancing the industry’s ability to focus on treatment of rare diseases, such as rare lung diseases.
Crucial Points from a Manufacturing Perspective (PDA/FDA Joint Regulatory Conference 2023)
October 17th 2023Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the important components of nitrosamine impurities from a manufacturing point of view as a part of his session, "Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View."
The Recent Discoveries of Nitrosamine Impurities (PDA/FDA Joint Regulatory Conference 2023)
October 16th 2023Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the recent findings of nitrosamine impurities in human drugs as a part of his session, "Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View."