iSpeak Blog
ISPE’s long-time Asia-Pacific Regulatory Advisor Bob Tribe retired from ISPE at the end of 2022, bringing to a close more than 18 years of service to the Society.
iSpeak Blog
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...
iSpeak Blog
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...
iSpeak Blog
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...
iSpeak Blog
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...