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

The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...

iSpeak Blog

Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...

iSpeak Blog

To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...

iSpeak Blog

Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...

iSpeak Blog

Biopharmaceutical facility design is a critical aspect of the industry. Overall cost pressures in the global health system, regional requirements to deploy manufacturing rather than centralize manufacturing in one location, technology enhancements in cell biology and format, flexibility to accommodate multi-product campaigns with different production schedules, and speed-to-market are among...

iSpeak Blog

The biotechnology industry continues to evolve, advancing the frontiers of science and engineering in the design, development, and manufacture of a wide variety of therapeutic modalities. Advances in cell and gene therapies continue to offer treatments for diseases that were previously uncurable, with seven approvals in 2023, including treatments for sickle-cell disease, hemophilia, type 1...

iSpeak Blog

The International Society of Pharmaceutical Engineering’s (ISPE) Women in Pharma® group was established in 2017. Since its inception, it has grown to a community of more than 2,000 members who are actively engaged in educational, collaborative, and networking activities designed to bridge gender, cultural, organizational, and geographic boundaries, maximize the impact women have in...

iSpeak Blog

Since starting with ISPE, Edyna Miguez, has had the incredible opportunity to connect with women across the globe working within the pharmaceutical industry, as part of the ISPE Women in Pharma® program. The tenure of these rising female leaders varies, as do their cultural backgrounds. However, one fact remains consistent: they are looking to make the industry a more equitable and...

iSpeak Blog

It is an exciting time in life sciences. Many companies have focused initial artificial intelligence/machine learning (AI/ML) adoption efforts on developing and implementing ML trained algorithms, which necessitate following a controlled approach such as the GAMP® 5 ML Sub-System methodology shown below. This blog highlights key artifacts and considerations when implementing AI/ML for GxP use...

iSpeak Blog

ISPE’s Regulatory Quality Harmonization Committee (RQHC) is structured with four Regional Focus Groups (RFGs): Asia-Pacific, Europe/Middle East/Africa, Latin America, and North America. The RFGs support ISPE in its understanding and response to regulatory issues and concerns for the specific region. The RQHC Asia-Pacific RFG includes pharmaceutical professionals located in or having specific...