Submit Your Best Content to ISPE

ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.  

What We Look For 

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...

iSpeak Blog

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...

iSpeak Blog

We are The Culture Club, a self-formed cross-CoP group of individuals who came together to discuss challenges encountered as we transition quality and validation into the digital world and identify ways to influence cultural changes needed within our industry to better enable innovation. As we are not all from the same CoP, we first needed to establish a way to connect and collaborate with all...

iSpeak Blog

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are some articles to start off the new year right! We revisit a favorite topic, sustainability—and will be updating our coverage of this topic with the upcoming March-April 2023 issue of Pharmaceutical Engineering.

iSpeak Blog

It has been a long journey from the development of primarily manual aseptic processes to fully automated systems that do not require manual intervention. Looking back in history, it was a step-by-step development forward to the current contamination control strategy (CCS) many decades ago. The risk of contamination of a sterile product from the environment (room) and the people who do work in...

iSpeak Blog

Cultural Excellence is the expressed and implied ways in which an organization operates. Excellence in organizational culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes. Culture determines quality outcomes by affecting the organization’s ability to identify and act upon near-miss shortages, ensuring the integrity of its data,...

iSpeak Blog

ISPE’s Women in Pharma® group strives to tackle unconscious biases that limit women, and other marginalized groups, within the pharmaceutical community. Over the last few years, the group has grown to be a global force across borders, connecting industry professionals through regional and international programming, including having a presence at the 2022 ISPE Annual Meeting &...

iSpeak Blog

Multi-Use Filling Line for RTU Syringes, Vials, Cartridges and Bulk Vials - Photo courtesy of INCOG BioPharma Services


The definition of technology is “the set of knowledge, skills, experience, and techniques through which humans change, transform and use our environment in order to create tools, machines, products and services that meet our needs and desires.” A...

iSpeak Blog

We are The Culture Club, a self-formed cross-COP group of individuals who came together to discuss challenges encountered as we transition quality and validation into the digital world and identify ways to influence cultural changes needed within our industry to better enable innovation. As we are not all from the same COP, we first need to establish a way to connect and collaborate with all...

iSpeak Blog

Excellence is everywhere, and it must be illuminated. For the fourth consecutive year, the annual ISPE Italy Affiliate Award for women in the pharmaceutical sector will be organized by the local group of ISPE Women in Pharma® (WIP). This important initiative was created to celebrate the commitment, perseverance, professionalism and competence of the women who work in this sector, qualities...