ATMPs, Cell and Genetic therapies - or whatever other jurisdictions use – have come a long way. I am unsure how many of us have forgotten the early failures and setbacks. There was a time, in the early years, when serious side effects, such as deaths, endangered the field. It prompted the regulators to halt research, introducing various constraints and safeguards. In Europe, it felt like every...
Opening keynote addresses at the 2023 ISPE Facilities of the Future Conference focused on innovation in planning for future pandemics and reinventing medicines for a healthier world. The two-day conference on 31 January–1 February featured a range of sessions on topics including biomanufacturing, cell and gene therapy, digital transformation and Pharma 4.0™, emerging technologies, and facility...
On December 9-10, 2022, the two-day Senlan Bay Forum – ISPE Biopharmaceutical Engineering Summit 2022 was successfully held in Shanghai Peony Garden! The summit focused on the segmental production of macromolecules; the difficulties in the industrialization of gene and cell therapy; the construction of compliant and efficient CGT facilities; the process performance qualification (PPQ) for...
The ISPE Commissioning and Qualification (C&Q) Community of Practice (CoP) Steering Committee has developed a C&Q benchmarking survey intended to provide a comprehensive view of the current state of the industry, including adoption rate of Quality Risk Management (QRM) Based Integrated C&Q, C&Q best practices and key performance indicators. Completing this industry benchmarking...
Most Life Sciences manufacturers face issues while tracking material, equipment, and finished products in one way or another. While RFID solutions have been in use for a long time, they still can fail to identify the object because of constraints of reading requirements of distance. Real Time Location Systems (RTLS) solution can work as a panacea to overcome those constraints. These solutions...
