Platform Technologies and Regulatory Sandboxes

Rubrik: europharm

(Treffer aus pharmind, Nr. 12, Seite 1082 (2025))

von Fritschen M | Schmidt L | Ehmann F | Broich K | Vieths S | Hildebrandt M | Stegemann S | Bilanin M

Platform Technologies and Regulatory Sandboxes / A Blueprint for Accelerated Innovation in EU Pharmaceutical Legislation · von Fritschen M, Schmidt, LL.M. F, Ehmann F, Broich K, Vieths S, Hildebrandt M, Stegemann S, Bilanin M · HTW Berlin und DG SANTE European Commission und European Medicines Agency und Bundesinstitut für Arzneimittel und Medizinprodukte und Paul Ehrlich Institut und TUM School of Medicine, BZKF und Leibniz JointLab First in Translation und GSK, on behalf of EFPIA, Vaccines Europe
Platform Technology Regulatory Sandbox EU Pharma Legislation PTMF Patient Innovation The current revision of the EU pharmaceutical legislation represents the most significant reform in over 2 decades. Its goal is to ensure faster, equitable access to innovative medicines for patients while strengthening EU competitiveness through more flexible tools. Two such instruments were featured prominently in the opening session of the Human Medicines Track at the TOPRA Symposium 2025: the concepts of “Platform Technologies” and the “Regulatory Sandbox”. Together, they modernize the EU regulatory framework to accommodate emerging scientific modalities and adaptive innovative pathways (tab. 1). Stage Legal source [ 1 ], ...

Aseptic Transfer Systems

Rubrik: Technik

(Treffer aus pharmind, Nr. 11, Seite 1034 (2025))

Krebsbach T | Lehmann F

Aseptic Transfer Systems / For Isolator and RABS · Krebsbach T, Lehmann F · SKAN
Isolator Aseptic Processing Annex 1 Material Transfer Aseptic Transfer Advisor (ATA) Over the past 2 decades, isolator technology has deservedly positioned itself at the forefront of the safest production environments in the pharmaceutical industry [ 1 ], both in the manufacturing and quality control of sterile medicinal products. This is also reflected in Annex 1 of the EC GMP Guide published in Aug. 2022, which explicitly recommends the use of barrier technology, as it significantly increases product protection against potential contamination in the form of endotoxins/pyrogens, particulate matter, and microbial contaminants caused, e.g. by personnel, materials, or the environment [ 2 ]. Consequently, ...

Electron-Beam Tunnel

Rubrik: Reinraum

(Treffer aus Tech4Pharma, Nr. 02, Seite 84 (2025))

Holzer M | Lehmann F

Electron-Beam Tunnel / An Annex-1-Compliant RTU Transfer System · Holzer M, Lehmann F · Skan
Ebeam Surface sterilization Ionizing radiation Pre-filled/Pre-sterilized RTU packaging material Isolator technology Aseptic transfer The sterilization of surfaces with beta rays (electron-beam, ebeam) has been known for a long time and has been well accepted in the food and medical device industry as well as by the U.S. Food and Drug Administration (FDA) and other regulatory authorities in the pharmaceutical industry [ 1 ]. What is new for the pharmaceutical industry is the speed at which ready-to-use (RTU) packaging material can be aseptically fed into the aseptic filling area of high-speed filling lines using an ebeam tunnel with continuous feeding. With ...