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.

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...

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...

It’s hard to imagine life without instantaneous weather and time; however, some readers of this blog may know when weather, some years ago, was a mystery, and accurate time required a call from a pay phone to verify the correctness of your new Timex© watch!

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.

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...

Building off of the success of the 2022 ISPE Aseptic Conference, the program committee has developed a robust program covering key areas in aseptic manufacturing, processing, and filling for students, emerging...

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,...

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 &...

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...

ISPE’s Women in Pharma^® ended the year strong with their latest webinar: Digitalization in Business Processes that Support Sustainability & Economy of Means.

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...

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...

The ISPE Singapore Affiliate 2022 Conference and Exhibition is a WRAP! I was fortunate to chair both the pre-conference symposium opening plenary and the ‘Post Pandemic Transformation’ track.

A key challenge in life sciences is the detrimental effect of unplanned downtime and lost batches due to unanticipated equipment failure. Traditional maintenance programs are calendar or condition-based and can range from being overly conservative to reactive, leaving money on the table (over-maintenance - “just in case”), or jeopardizing productivity altogether. As described in the ISPE Good...

As one of the founders of Cheme Engineering, Nik Krpan was instrumental in the start-up of the company. He became president of the company in 2012. Nik says that leading the company through continued growth has been an exciting aspect of his career. “We started with five people and now we have more than sixty. It’s been really rewarding to be part of a creating an environment where people can...

The 2023 ISPE Aseptic Conference will devote one entire day to case studies related to aseptic manufacturing projects. For us, seeing the real-life challenges that the industry is facing and how project teams...