The pharmaceutical industry is undergoing a remarkable transformation, with advanced modalities like antibody-drug conjugates (ADCs) and radiopharmaceuticals driving the evolution of precision medicine. These innovations are not only redefining drug development but are also improving patient outcomes through targeted therapies, reduced side effects, and expanded treatment options. The...
On 13 March 2024, ISPE concluded the 2024 Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to representatives from the Austrian Agency for Health and Food Safety (AGES), US Food and Drug Administration (FDA), Regierungspraesidium Tübingen (RP Tübingen), World Health Organization (WHO), Therapeutic Goods Administration (TGA), and...
Annex 1 has been in effect since August 2023. But what has been its impact? This topic will be discussed at the 2024 ISPE Aseptic Conference in Vienna, Austria and virtually. Speakers from both industry and...
On 7 March 2023, ISPE continued its tradition of concluding the 2023 ISPE Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to the FDA representatives. This article offers highlights from the discussion.
The new European Commission GMP Annex 1 “Manufacture of Sterile Medicinal Products” and the equivalent Annex 2 from the World Health Organization (WHO) triggered a discussion in ISPE’s Germany/Austria/Switzerland (D/A/CH) Aseptic Processing Community of Practice (CoP) Steering Committee about where to qualify air speed: “at working position” versus “at working level.” This article provides...
On 7 March 2023, ISPE concluded the 2023 ISPE Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to the FDA representatives. This article offers highlights from the discussion.
