The Biopharmaceutical industry continues to grow and deliver life-changing medicines to patients as evidenced by the number of drug approvals by the FDA year after year. In 2022 alone CDER approved 37 novel drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biological products under Biologics License Applications (BLAs). This has all been...
The 2022 ISPE Pharma 4.0™ Emerging Leader Hackathon event was organized by the ISPE Emerging Leaders DACH Affiliate in collaboration with the ISPE Pharma 4.0™ Community of Practice (CoP) Plug and Produce Subcommittee. The goal was to bring together students and young professionals from different fields of study and countries together to explore the emerging challenges and opportunities in...
The lifecycle of interfaces is of crucial importance for the interoperability of systems from different technical and organizational areas within or between companies.
Interfaces are the integration points of connected systems for the transmission of master or transaction data including status updates. Interfaces are typically parts of data streams or data hierarchies, e.g., Lab...
The pharmaceutical industry is rapidly evolving. The major trends in the recent years are (1) fully automated production such as continuous manufacturing and (2) the adoption of digitalized processes for paperless production. Both approaches have significant implications for Annex 1 compliance and the role of Contract Manufacturing Organizations (CMOs) in production facilitating these...
